Food Matrices Based on Fruit Pastes as Vectors of Carbohydrates for the Prevention and Management of Protein-energy Undernutrition in the Elderly (Fruisenior)

University Hospital, Clermont-Ferrand15 enrolled

Overview

To develop more natural fruit pastes matrices that can effectively act as carbohydrate vectors in the elderly population and that are part of a normal diet while maintaining the pleasure of eating.

This is an interventional randomized, single blinded, cross over and controlled study. The main objective is the study of the kinetic modification of blood glucose with the "fruit" matrices enriched in maltodextrins, fructose and isomaltulose compared to the original recipe consisting only of simple sugars. The secondary objective is: -the assessment of the acceptability of all the fruit pastes tested (organoleptic, satiety and gastrointestinal comfort aspects).The study is composed of 7 visits Visit 1 - Selection Visit (Day -7) * Informed consent form * Clinical examination * Medical history * Anthropometric characteristics * Blood biochemical and hematological assessment * Compliance test with the original matrix will be carried out Visit 2 (D0) / Visit 3 (D7) / Visit 4 (D14) / Visit 5 (D21) / Visit 6 (D28): study period If all the biological criteria are respected, the subjects will have to come back to the clinical center for each of the 5 study periods. Volunteers will arrive fasted, without smoking in the morning. A catheter will be placed for blood sampling. After a first blood sampling for basal values, volunteers will ingest the equivalent of two bars of fruit pastes (about 80g in 10 minutes maximum) and blood will be withdrawn 15, 30, 45, 60, 90, 120 and 180 minutes after ingestion. The different matrices (5 in total) will be tested on the same volunteer. Plasma samples will be used to determine plasma glucose and fructose concentrations (aliquots stored in center for later assays) to evaluate the postprandial profiles of these two nutrients. At the end of the kinetic, the volunteers will be offered a complete meal. A satiety questionnaire will be performed before then 60 and 180 min after the ingestion of each fruit matrix. A questionnaire of satisfaction and acceptability will also be realized during the consumption of the matrix. After the 5 fruit matrix will be tested, the subject will be invited to participate in an individual interview of about 30-45min with a member of the project team. The purpose of this interview will be a qualitative approach to search for a food development that can could improve the sensory quality of the fruit pastes tested and intended for the elderly (see below). Visit 7 (D35 to D40): Participation in a discussion group (about 2 hours). During the participation in this group all 10 participants will be invited to taste the 5 products (original recipe, maltodextrin recipe, fructose recipe, isomaltulose recipe and mixed recipe comprising fructose and isomaltulose). Participants will be asked to indicate for each product their degree of appreciation for these products, their possible defects and qualities and to suggest ideas for improving their taste / texture / appearance. These interviews will alternate individual reflection phases and discussion phases according to the focus group method. Visit 7 will be the last visit of the study.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

SINGLE

Enrollment

Conditions

Healthy

Interventions

fruit paste matriceOTHER

Evaluation of the kinetics of the appearance of nutrients and the metabolic response induced by the consumption of fruit pastes (5 different matrices will be tested: 1 Original recipe, 1 maltodextrine recipe, 1 fructose recipe, 1 isomaltulose recipe and 1 mixed recipe comprising fructose and isomaltulose) in elderly healthy volunteers.

Eligibility

Sex: MALEMin age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Male subject * Subject over 65 years (included) * Subject over 61 kg (included) * Able to consume the 80g of fruit pastes in 10 minutes * Subject with a dentition consistent with the fruit paste consumption in 10 minutes * Subject with a Body Mass Index (BMI) between 21 and 30 kg/m2 * Subject agreeing to provide written consent Exclusion Criteria: * Subject with acute pathology (unstable or terminal pathology, severe dementia) * Subject with renal failure (clearance \< 60 ml/min) * Subject with metabolic syndrome (3 of the following 5 criteria: waist greater than 94 cm, blood triglyceride greater than 1.7 mmol/l, blood pressure greater than or equal to 130 mm Hg/85 mm Hg, cholesterol (HDL) less than 1.0 mmol/l in men, blood glucose greater than or equal to 5.6 mmol/l) * Person with diabetes * Subject on food restriction * Subject undergoing chemotherapy * Subject with gastrointestinal pathology * Subject in a diet incompatible with the nutritional protocol (gluten, lactose or milk intolerance, vegan)

Locations (1)

CHU de Clermont-Ferrand

Clermont-Ferrand, France

Outcomes

Primary Outcomes

Area Under the Curve (AUC) of glycemia

Area Under the Curve (AUC) of glycemia (defined in mmol/L) between T0 and T120 minutes following ingestion of fruit paste.

Time frame: Day 0

Maximum Plasma Concentration (Cmax) of glycemia

Maximum Plasma Concentration (Cmax) of glycemia (defined in mmol/L) between T0 and T120 minutes following ingestion of fruit paste.

Time frame: Day 0

Time of Maximum Plasma Concentration (Tmax) of glycemia

Time of Maximum Plasma Concentration (Tmax) of glycemia (defined in mmol/L) between T0 and T120 minutes following ingestion of fruit paste.

Time frame: Day 0

Area Under the Curve (AUC) of glycemia

Area Under the Curve (AUC) of glycemia (defined in mmol/L) between T0 and T120 minutes following ingestion of fruit paste.

Time frame: Day 7

Maximum Plasma Concentration (Cmax) of glycemia

Maximum Plasma Concentration (Cmax) of glycemia (defined in mmol/L) between T0 and T120 minutes following ingestion of fruit paste.

Time frame: Day 7

Time of Maximum Plasma Concentration (Tmax) of glycemia

Time of Maximum Plasma Concentration (Tmax) of glycemia (defined in mmol/L) between T0 and T120 minutes following ingestion of fruit paste.

Time frame: day 7

Area Under the Curve (AUC) of glycemia

Area Under the Curve (AUC) of glycemia (defined in mmol/L) between T0 and T120 minutes following ingestion of fruit paste.

Time frame: day 14

Data from ClinicalTrials.gov

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Secondary Outcomes

Area Under the Curve (AUC) of fructose

Area Under the Curve (AUC) of fructose (defined in g/L) between T0 and T120 minutes following ingestion of fruit paste.

Time frame: Day 0

Maximum Plasma Concentration (Cmax) of fructose

Maximum Plasma Concentration (Cmax) of fructose (defined in g/L) between T0 and T120 minutes following ingestion of fruit paste.

Time frame: Day 0

Time of Maximum Plasma Concentration (Tmax) of fructose

Time of Maximum Plasma Concentration (Tmax) of fructose (defined in g/L) between T0 and T120 minutes following ingestion of fruit paste.

Time frame: Day 0

Area Under the Curve (AUC) of fructose

Area Under the Curve (AUC) of fructose (defined in g/L) between T0 and T120 minutes following ingestion of fruit paste

Time frame: Day 7

Maximum Plasma Concentration (Cmax) of fructose

Maximum Plasma Concentration (Cmax) of fructose (defined in g/L) between T0 and T120 minutes following ingestion of fruit paste.

Time frame: Day 7

Time of Maximum Plasma Concentration (Tmax) of fructose

Time of Maximum Plasma Concentration (Tmax) of fructose (defined in g/L) between T0 and T120 minutes following ingestion of fruit paste.

Time frame: Day 7

Area Under the Curve (AUC) of fructose

Area Under the Curve (AUC) of fructose (defined in g/L) between T0 and T120 minutes following ingestion of fruit paste.

Time frame: Day 14

Maximum Plasma Concentration (Cmax) of fructose

Maximum Plasma Concentration (Cmax) of fructose (defined in g/L) between T0 and T120 minutes following ingestion of fruit paste.

Time frame: Day 14

Time of Maximum Plasma Concentration (Tmax) of fructose

Time of Maximum Plasma Concentration (Tmax) of fructose (defined in g/L) between T0 and T120 minutes following ingestion of fruit paste.

Time frame: Day 14

Area Under the Curve (AUC) of fructose

Area Under the Curve (AUC) of fructose (defined in g/L) between T0 and T120 minutes following ingestion of fruit paste

Time frame: Day 21

Maximum Plasma Concentration (Cmax) of fructose

Maximum Plasma Concentration (Cmax) of fructose (defined in g/L) between T0 and T120 minutes following ingestion of fruit paste.

Time frame: Day 21

Time of Maximum Plasma Concentration (Tmax) of fructose

Time of Maximum Plasma Concentration (Tmax) of fructose (defined in g/L) between T0 and T120 minutes following ingestion of fruit paste.

Time frame: Day 21

Area Under the Curve (AUC) of fructose

Area Under the Curve (AUC) of fructose (defined in g/L) between T0 and T120 minutes following ingestion of fruit paste

Time frame: Day 28

Maximum Plasma Concentration (Cmax) of fructose

Maximum Plasma Concentration (Cmax) of fructose (defined in g/L) between T0 and T120 minutes following ingestion of fruit paste.

Time frame: Day 28

Time of Maximum Plasma Concentration (Tmax) of fructose

Time of Maximum Plasma Concentration (Tmax) of fructose (defined in g/L) between T0 and T120 minutes following ingestion of fruit paste.

Time frame: Day 28

Area Under the Curve (AUC) of glucagon

Area Under the Curve (AUC) of glucagon (defined in np/mL) between T0 and T120 minutes following ingestion of fruit paste.

Time frame: day 0

Maximum Plasma Concentration (Cmax) of glucagon

: Maximum Plasma Concentration (Cmax) of glucagon (defined in np/mL) between T0 and T120 minutes following ingestion of fruit paste.

Time frame: day 0

Time of Maximum Plasma Concentration (Tmax) of glucagon

Time of Maximum Plasma Concentration (Tmax) of glucagon (defined in np/mL) between T0 and T120 minutes following ingestion of fruit paste.

Time frame: day 0

Area Under the Curve (AUC) of glucagon

Area Under the Curve (AUC) of glucagon (defined in np/mL) between T0 and T120 minutes following ingestion of fruit paste

Time frame: day 7

Maximum Plasma Concentration (Cmax) of glucagon

Maximum Plasma Concentration (Cmax) of glucagon (defined in np/mL) between T0 and T120 minutes following ingestion of fruit paste

Time frame: day 7

Time of Maximum Plasma Concentration (Tmax) of glucagon

Time of Maximum Plasma Concentration (Tmax) of glucagon (defined in np/mL) between T0 and T120 minutes following ingestion of fruit paste

Time frame: Day 7

Area Under the Curve (AUC) of glucagon

Area Under the Curve (AUC) of glucagon (defined in np/mL) between T0 and T120 minutes following ingestion of fruit paste

Time frame: Day 14

Maximum Plasma Concentration (Cmax) of glucagon

Maximum Plasma Concentration (Cmax) of glucagon (defined in np/mL) between T0 and T120 minutes following ingestion of fruit paste.

Time frame: Day 14

Time of Maximum Plasma Concentration (Tmax) of glucagon

Time of Maximum Plasma Concentration (Tmax) of glucagon (defined in np/mL) between T0 and T120 minutes following ingestion of fruit paste

Time frame: Day 14

Area Under the Curve (AUC) of glucagon

Area Under the Curve (AUC) of glucagon (defined in np/mL) between T0 and T120 minutes following ingestion of fruit paste.

Time frame: Day 21

Maximum Plasma Concentration (Cmax) of glucagon

Maximum Plasma Concentration (Cmax) of glucagon (defined in np/mL) between T0 and T120 minutes following ingestion of fruit paste.

Time frame: Day 21

Time of Maximum Plasma Concentration (Tmax) of glucagon

Time of Maximum Plasma Concentration (Tmax) of glucagon (defined in np/mL) between T0 and T120 minutes following ingestion of fruit paste.

Time frame: Day 21

Area Under the Curve (AUC) of glucagon

Area Under the Curve (AUC) of glucagon (defined in np/mL) between T0 and T120 minutes following ingestion of fruit paste

Time frame: Day 28

Maximum Plasma Concentration (Cmax) of glucagon

Maximum Plasma Concentration (Cmax) of glucagon (defined in np/mL) between T0 and T120 minutes following ingestion of fruit paste.

Time frame: Day 28

Time of Maximum Plasma Concentration (Tmax) of glucagon

Time of Maximum Plasma Concentration (Tmax) of glucagon (defined in np/mL) between T0 and T120 minutes following ingestion of fruit paste.

Time frame: Day 28

Area Under the Curve (AUC) of CCK

Area Under the Curve (AUC) of CCK (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste.

Time frame: Day 0

Maximum Plasma Concentration (Cmax) of CCK

Maximum Plasma Concentration (Cmax) of CCK (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste

Time frame: Day 0

Time of Maximum Plasma Concentration (Tmax) of CCK

Time of Maximum Plasma Concentration (Tmax) of CCK (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste.

Time frame: Day 0

Area Under the Curve (AUC) of CCK

Area Under the Curve (AUC) of CCK (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste.

Time frame: Day 7

Maximum Plasma Concentration (Cmax) of CCK

Maximum Plasma Concentration (Cmax) of CCK (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste

Time frame: Day 7

Time of Maximum Plasma Concentration (Tmax) of CCK

Time of Maximum Plasma Concentration (Tmax) of CCK (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste.

Time frame: Day 7

Area Under the Curve (AUC) of CCK

Area Under the Curve (AUC) of CCK (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste.

Time frame: Day 14

Maximum Plasma Concentration (Cmax) of CCK

Maximum Plasma Concentration (Cmax) of CCK (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste.

Time frame: Day 14

Time of Maximum Plasma Concentration (Tmax) of CCK

Time of Maximum Plasma Concentration (Tmax) of CCK (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste.

Time frame: Day 14

Area Under the Curve (AUC) of CCK

Area Under the Curve (AUC) of CCK (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste

Time frame: Day 21

Maximum Plasma Concentration (Cmax) of CCK

Maximum Plasma Concentration (Cmax) of CCK (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste

Time frame: Day 21

Time of Maximum Plasma Concentration (Tmax) of CCK

Time of Maximum Plasma Concentration (Tmax) of CCK (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste.

Time frame: Day 21

Area Under the Curve (AUC) of CCK

Area Under the Curve (AUC) of CCK (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste.

Time frame: Day 28

Maximum Plasma Concentration (Cmax) of CCK

Maximum Plasma Concentration (Cmax) of CCK (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste.

Time frame: Day 28

Time of Maximum Plasma Concentration (Tmax) of CCK

Time of Maximum Plasma Concentration (Tmax) of CCK (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste.

Time frame: Day 28

Area Under the Curve (AUC) of Grehlin

Area Under the Curve (AUC) of Grehlin (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste.

Time frame: Day 0

Maximum Plasma Concentration (Cmax) of Grehlin

Maximum Plasma Concentration (Cmax) of Grehlin (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste.

Time frame: Day 0

Time of Maximum Plasma Concentration (Tmax) of Grehlin

Time of Maximum Plasma Concentration (Tmax) of Grehlin (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste.

Time frame: day 0

Area Under the Curve (AUC) of Grehlin

Area Under the Curve (AUC) of Grehlin (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste

Time frame: day 7

Maximum Plasma Concentration (Cmax) of Grehlin

Maximum Plasma Concentration (Cmax) of Grehlin (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste.

Time frame: day 7

Time of Maximum Plasma Concentration (Tmax) of Grehlin

Time of Maximum Plasma Concentration (Tmax) of Grehlin (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste

Time frame: day 7

Area Under the Curve (AUC) of Grehlin

Area Under the Curve (AUC) of Grehlin (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste

Time frame: day 14

Maximum Plasma Concentration (Cmax) of Grehlin

Maximum Plasma Concentration (Cmax) of Grehlin (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste.

Time frame: day 14

Time of Maximum Plasma Concentration (Tmax) of Grehlin

Time of Maximum Plasma Concentration (Tmax) of Grehlin (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste.

Time frame: day 14

Area Under the Curve (AUC) of Grehlin

Area Under the Curve (AUC) of Grehlin (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste

Time frame: day 21

Maximum Plasma Concentration (Cmax) of Grehlin

Maximum Plasma Concentration (Cmax) of Grehlin (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste.

Time frame: day 21

Time of Maximum Plasma Concentration (Tmax) of Grehlin

Time of Maximum Plasma Concentration (Tmax) of Grehlin (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste.

Time frame: day 21

Area Under the Curve (AUC) of Grehlin

Area Under the Curve (AUC) of Grehlin (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste

Time frame: day 28

Maximum Plasma Concentration (Cmax) of Grehlin

Maximum Plasma Concentration (Cmax) of Grehlin (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste.

Time frame: day 28

Time of Maximum Plasma Concentration (Tmax) of Grehlin

Time of Maximum Plasma Concentration (Tmax) of Grehlin (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste.

Time frame: day 28

Area Under the Curve (AUC) of leptin

Area Under the Curve (AUC) of leptin (defined in ng/L) between T0 and T120 minutes following ingestion of fruit paste

Time frame: day 0

Maximum Plasma Concentration (Cmax) of leptin

Maximum Plasma Concentration (Cmax) of leptin (defined in ng/L) between T0 and T120 minutes following ingestion of fruit paste.

Time frame: day 0

Time of Maximum Plasma Concentration (Tmax) of leptin

Time of Maximum Plasma Concentration (Tmax) of leptin (defined in ng/L) between T0 and T120 minutes following ingestion of fruit paste.

Time frame: day 0

Area Under the Curve (AUC) of leptin

Area Under the Curve (AUC) of leptin (defined in ng/L) between T0 and T120 minutes following ingestion of fruit paste

Time frame: day 7

Maximum Plasma Concentration (Cmax) of leptin

Maximum Plasma Concentration (Cmax) of leptin (defined in ng/L) between T0 and T120 minutes following ingestion of fruit paste.

Time frame: day 7

Time of Maximum Plasma Concentration (Tmax) of leptin

Time of Maximum Plasma Concentration (Tmax) of leptin (defined in ng/L) between T0 and T120 minutes following ingestion of fruit paste

Time frame: day 7

Area Under the Curve (AUC) of leptin

Area Under the Curve (AUC) of leptin (defined in ng/L) between T0 and T120 minutes following ingestion of fruit paste

Time frame: day 14

Maximum Plasma Concentration (Cmax) of leptin

Maximum Plasma Concentration (Cmax) of leptin (defined in ng/L) between T0 and T120 minutes following ingestion of fruit paste

Time frame: day 14

Time of Maximum Plasma Concentration (Tmax) of leptin

Time of Maximum Plasma Concentration (Tmax) of leptin (defined in ng/L) between T0 and T120 minutes following ingestion of fruit paste

Time frame: day 14

Area Under the Curve (AUC) of leptin

Area Under the Curve (AUC) of leptin (defined in ng/L) between T0 and T120 minutes following ingestion of fruit paste

Time frame: day 21

Maximum Plasma Concentration (Cmax) of leptin

Maximum Plasma Concentration (Cmax) of leptin (defined in ng/L) between T0 and T120 minutes following ingestion of fruit paste.

Time frame: day 21

Time of Maximum Plasma Concentration (Tmax) of leptin

Time of Maximum Plasma Concentration (Tmax) of leptin (defined in ng/L) between T0 and T120 minutes following ingestion of fruit paste.

Time frame: day 21

Area Under the Curve (AUC) of leptin

Area Under the Curve (AUC) of leptin (defined in ng/L) between T0 and T120 minutes following ingestion of fruit paste

Time frame: day 28

Maximum Plasma Concentration (Cmax) of leptin

Maximum Plasma Concentration (Cmax) of leptin (defined in ng/L) between T0 and T120 minutes following ingestion of fruit paste.

Time frame: day 28

Time of Maximum Plasma Concentration (Tmax) of leptin

Time of Maximum Plasma Concentration (Tmax) of leptin (defined in ng/L) between T0 and T120 minutes following ingestion of fruit paste.

Time frame: day 28

Area Under the Curve (AUC) of GLP1

Area Under the Curve (AUC) of GLP1 (defined in pmol/L) between T0 and T120 minutes following ingestion of fruit paste

Time frame: day 0

Maximum Plasma Concentration (Cmax) of GLP1

Maximum Plasma Concentration (Cmax) of GLP1 (defined in pmol /L) between T0 and T120 minutes following ingestion of fruit paste

Time frame: day 0

Time of Maximum Plasma Concentration (Tmax) of GLP1

Time of Maximum Plasma Concentration (Tmax) of GLP1 (defined in pmol /L) between T0 and T120 minutes following ingestion of fruit paste.

Time frame: day 0

Area Under the Curve (AUC) of GLP1

Area Under the Curve (AUC) of GLP1 (defined in pmol /L) between T0 and T120 minutes following ingestion of fruit paste.

Time frame: day 7

Maximum Plasma Concentration (Cmax) of GLP1

Maximum Plasma Concentration (Cmax) of GLP1 (defined in pmol /L) between T0 and T120 minutes following ingestion of fruit paste.

Time frame: day 7

Time of Maximum Plasma Concentration (Tmax) of GLP1

Time of Maximum Plasma Concentration (Tmax) of GLP1 (defined in pmol /L) between T0 and T120 minutes following ingestion of fruit paste

Time frame: day 7

Area Under the Curve (AUC) of GLP1

Area Under the Curve (AUC) of GLP1 (defined in pmol /L) between T0 and T120 minutes following ingestion of fruit paste

Time frame: day 14

Maximum Plasma Concentration (Cmax) of GLP1

Maximum Plasma Concentration (Cmax) of GLP1 (defined in pmol /L) between T0 and T120 minutes following ingestion of fruit paste.

Time frame: day 14

Time of Maximum Plasma Concentration (Tmax) of GLP1

Time of Maximum Plasma Concentration (Tmax) of GLP1 (defined in pmol /L) between T0 and T120 minutes following ingestion of fruit paste.

Time frame: day 14

Area Under the Curve (AUC) of GLP1

Area Under the Curve (AUC) of GLP1 (defined in pmol/L) between T0 and T120 minutes following ingestion of fruit paste

Time frame: day 21

Maximum Plasma Concentration (Cmax) of GLP1

Maximum Plasma Concentration (Cmax) of GLP1 (defined in pmol/L) between T0 and T120 minutes following ingestion of fruit paste.

Time frame: day 21

Time of Maximum Plasma Concentration (Tmax) of GLP1

Time of Maximum Plasma Concentration (Tmax) of GLP1 (defined in pmol /L) between T0 and T120 minutes following ingestion of fruit paste.

Time frame: day 21

Area Under the Curve (AUC) of GLP1

Area Under the Curve (AUC) of GLP1 (defined in pmol /L) between T0 and T120 minutes following ingestion of fruit paste

Time frame: day 28

Maximum Plasma Concentration (Cmax) of GLP1

Maximum Plasma Concentration (Cmax) of GLP1 (defined in pmol /L) between T0 and T120 minutes following ingestion of fruit paste

Time frame: day 28

Time of Maximum Plasma Concentration (Tmax) of GLP1

Time of Maximum Plasma Concentration (Tmax) of GLP1 (defined in pmol /L) between T0 and T120 minutes following ingestion of fruit paste.

Time frame: day 28

Area Under the Curve (AUC) of incretines

Area Under the Curve (AUC) of incretines (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste

Time frame: day 0

Maximum Plasma Concentration (Cmax) of incretines

Maximum Plasma Concentration (Cmax) of incretines (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste.

Time frame: day 0

Time of Maximum Plasma Concentration (Tmax) of incretines

Time of Maximum Plasma Concentration (Tmax) of incretines (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste.

Time frame: day 0

Area Under the Curve (AUC) of incretines

Area Under the Curve (AUC) of incretines (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste

Time frame: day 7

Maximum Plasma Concentration (Cmax) of incretines

Maximum Plasma Concentration (Cmax) of incretines (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste

Time frame: day 7

Time of Maximum Plasma Concentration (Tmax) of incretines

Time of Maximum Plasma Concentration (Tmax) of incretines (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste.

Time frame: day 7

Area Under the Curve (AUC) of incretines

Area Under the Curve (AUC) of incretines (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste

Time frame: day 14

Maximum Plasma Concentration (Cmax) of incretines

Maximum Plasma Concentration (Cmax) of incretines (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste.

Time frame: day 14

Time of Maximum Plasma Concentration (Tmax) of incretines

Time of Maximum Plasma Concentration (Tmax) of incretines (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste

Time frame: day 14

Area Under the Curve (AUC) of incretines

Area Under the Curve (AUC) of incretines (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste

Time frame: day 21

Maximum Plasma Concentration (Cmax) of incretines

Maximum Plasma Concentration (Cmax) of incretines (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste.

Time frame: day 21

Time of Maximum Plasma Concentration (Tmax) of incretines

Time of Maximum Plasma Concentration (Tmax) of incretines (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste

Time frame: day 21

Area Under the Curve (AUC) of incretines

Area Under the Curve (AUC) of incretines (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste

Time frame: day 28

Maximum Plasma Concentration (Cmax) of incretines

Maximum Plasma Concentration (Cmax) of incretines (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste.

Time frame: day 28

Time of Maximum Plasma Concentration (Tmax) of incretines

Time of Maximum Plasma Concentration (Tmax) of incretines (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste

Time frame: day 28

Area Under the Curve (AUC) of insulin

Area Under the Curve (AUC) of insulin (defined in µg/L) between T0 and T120 minutes following ingestion of fruit paste

Time frame: day 0

Maximum Plasma Concentration (Cmax) of insulin

Maximum Plasma Concentration (Cmax) of insulin (defined in µg/L) between T0 and T120 minutes following ingestion of fruit paste

Time frame: day 0

Time of Maximum Plasma Concentration (Tmax) of insulin

Time of Maximum Plasma Concentration (Tmax) of insulin (defined in µg/L) between T0 and T120 minutes following ingestion of fruit paste.

Time frame: day 0

Area Under the Curve (AUC) of insulin

Area Under the Curve (AUC) of insulin (defined in µg/L) between T0 and T120 minutes following ingestion of fruit paste

Time frame: day 7

Maximum Plasma Concentration (Cmax) of insulin

Maximum Plasma Concentration (Cmax) of insulin (defined in µg/L) between T0 and T120 minutes following ingestion of fruit paste

Time frame: day 7

Time of Maximum Plasma Concentration (Tmax) of insulin

Time of Maximum Plasma Concentration (Tmax) of insulin (defined in µg/L) between T0 and T120 minutes following ingestion of fruit paste.

Time frame: day 7

Area Under the Curve (AUC) of insulin

Area Under the Curve (AUC) of insulin (defined in µg/L) between T0 and T120 minutes following ingestion of fruit paste

Time frame: day 14

Maximum Plasma Concentration (Cmax) of insulin

Maximum Plasma Concentration (Cmax) of insulin (defined in µg/L) between T0 and T120 minutes following ingestion of fruit paste

Time frame: day 14

Time of Maximum Plasma Concentration (Tmax) of insulin

Time of Maximum Plasma Concentration (Tmax) of insulin (defined in µg/L) between T0 and T120 minutes following ingestion of fruit paste

Time frame: day 14

Area Under the Curve (AUC) of insulin

Area Under the Curve (AUC) of insulin (defined in µg/L) between T0 and T120 minutes following ingestion of fruit paste

Time frame: day 21

Maximum Plasma Concentration (Cmax) of insulin

Maximum Plasma Concentration (Cmax) of insulin (defined in µg/L) between T0 and T120 minutes following ingestion of fruit paste

Time frame: day 21

Time of Maximum Plasma Concentration (Tmax) of insulin

Time of Maximum Plasma Concentration (Tmax) of insulin (defined in µg/L) between T0 and T120 minutes following ingestion of fruit paste.

Time frame: day 21

Area Under the Curve (AUC) of insulin

Area Under the Curve (AUC) of insulin (defined in µg/L) between T0 and T120 minutes following ingestion of fruit paste

Time frame: day 28

Maximum Plasma Concentration (Cmax) of urea

Maximum Plasma Concentration (Cmax) of urea (defined in µg/L) between T0 and T120 minutes following ingestion of fruit paste

Time frame: day 28

Time of Maximum Plasma Concentration (Tmax) of insulin

Time of Maximum Plasma Concentration (Tmax) of insulin (defined in µg/L) between T0 and T120 minutes following ingestion of fruit paste.

Time frame: day 28

Area Under the Curve (AUC) of urea

Area Under the Curve (AUC) of urea (defined in mmol/L) between T0 and T120 minutes following ingestion of fruit paste

Time frame: day 0

Maximum Plasma Concentration (Cmax) of urea

Maximum Plasma Concentration (Cmax) of urea (defined in mmol/L) between T0 and T120 minutes following ingestion of fruit paste

Time frame: day 0

Time of Maximum Plasma Concentration (Tmax) of urea

Time of Maximum Plasma Concentration (Tmax) of urea (defined in mmol/L) between T0 and T120 minutes following ingestion of fruit paste.

Time frame: day 0

Area Under the Curve (AUC) of urea

Area Under the Curve (AUC) of urea (defined in mmol/L) between T0 and T120 minutes following ingestion of fruit paste

Time frame: day 7

Maximum Plasma Concentration (Cmax) of urea

Maximum Plasma Concentration (Cmax) of urea (defined in mmol/L) between T0 and T120 minutes following ingestion of fruit paste

Time frame: day 7

Time of Maximum Plasma Concentration (Tmax) of urea

Time of Maximum Plasma Concentration (Tmax) of urea (defined in mmol/L) between T0 and T120 minutes following ingestion of fruit paste.

Time frame: day 7

Area Under the Curve (AUC) of urea

Area Under the Curve (AUC) of urea (defined in mmol/L) between T0 and T120 minutes following ingestion of fruit paste.

Time frame: day 14

Maximum Plasma Concentration (Cmax) of urea

Maximum Plasma Concentration (Cmax) of urea (defined in mmol/L) between T0 and T120 minutes following ingestion of fruit paste

Time frame: day 14

Time of Maximum Plasma Concentration (Tmax) of urea

Time of Maximum Plasma Concentration (Tmax) of urea (defined in mmol/L) between T0 and T120 minutes following ingestion of fruit paste.

Time frame: day 14

Area Under the Curve (AUC) of urea

Area Under the Curve (AUC) of urea (defined in mmol/L) between T0 and T120 minutes following ingestion of fruit paste

Time frame: day 21

Maximum Plasma Concentration (Cmax) of urea

Maximum Plasma Concentration (Cmax) of urea (defined in mmol/L) between T0 and T120 minutes following ingestion of fruit paste

Time frame: day 21

Time of Maximum Plasma Concentration (Tmax) of urea

Time of Maximum Plasma Concentration (Tmax) of urea (defined in mmol/L) between T0 and T120 minutes following ingestion of fruit paste.

Time frame: day 21

Area Under the Curve (AUC) of urea

Area Under the Curve (AUC) of urea (defined in mmol/L) between T0 and T120 minutes following ingestion of fruit paste

Time frame: day 28

Maximum Plasma Concentration (Cmax) of urea

Maximum Plasma Concentration (Cmax) of urea (defined in mmol/L) between T0 and T120 minutes following ingestion of fruit paste.

Time frame: day 28

Time of Maximum Plasma Concentration (Tmax) of urea

Time of Maximum Plasma Concentration (Tmax) of urea (defined in mmol/L) between T0 and T120 minutes following ingestion of fruit paste

Time frame: day 28

Questionnaire of satiety

Questionnaire was composed of 4 questions where satiety was assessed by a 0-10 Numerical Satiety Rating Scale where "0" means to be free from hunger and "10" to be very hungry.

Time frame: at time 0 after ingestion in Day 0

Questionnaire of satiety

Questionnaire was composed of 4 questions where satiety was assessed by a 0-10 Numerical Satiety Rating Scale where "0" means to be free from hunger and "10" to be very hungry

Time frame: at time 60 after ingestion in Day 0

Questionnaire of satiety

Questionnaire was composed of 4 questions where satiety was assessed by a 0-10 Numerical Satiety Rating Scale where "0" means to be free from hunger and "10" to be very hungry.

Time frame: at time 180 after ingestion in Day 0

Questionnaire of satiety

Questionnaire was composed of 4 questions where satiety was assessed by a 0-10 Numerical Satiety Rating Scale where "0" means to be free from hunger and "10" to be very hungry

Time frame: at time 0 after ingestion in Day 7

Questionnaire of satiety

Questionnaire was composed of 4 questions where satiety was assessed by a 0-10 Numerical Satiety Rating Scale where "0" means to be free from hunger and "10" to be very hungry

Time frame: at time 60 after ingestion in Day 7

Questionnaire of satiety

Questionnaire was composed of 4 questions where satiety was assessed by a 0-10 Numerical Satiety Rating Scale where "0" means to be free from hunger and "10" to be very hungry.

Time frame: at time 180 after ingestion in Day 7

Questionnaire of satiety

Questionnaire was composed of 4 questions where satiety was assessed by a 0-10 Numerical Satiety Rating Scale where "0" means to be free from hunger and "10" to be very hungry.

Time frame: at time 0 after ingestion in Day 14

Questionnaire of satiety

Questionnaire was composed of 4 questions where satiety was assessed by a 0-10 Numerical Satiety Rating Scale where "0" means to be free from hunger and "10" to be very hungry

Time frame: at time 60 after ingestion in Day 14

Questionnaire of satiety

Questionnaire was composed of 4 questions where satiety was assessed by a 0-10 Numerical Satiety Rating Scale where "0" means to be free from hunger and "10" to be very hungry

Time frame: at time 180 after ingestion in Day 14

Questionnaire of satiety

Questionnaire was composed of 4 questions where satiety was assessed by a 0-10 Numerical Satiety Rating Scale where "0" means to be free from hunger and "10" to be very hungry.

Time frame: at time 0 after ingestion in Day 21

Questionnaire of satiety

Questionnaire was composed of 4 questions where satiety was assessed by a 0-10 Numerical Satiety Rating Scale where "0" means to be free from hunger and "10" to be very hungry.

Time frame: at time 60 after ingestion in Day 21

Questionnaire of satiety

Questionnaire was composed of 4 questions where satiety was assessed by a 0-10 Numerical Satiety Rating Scale where "0" means to be free from hunger and "10" to be very hungry.

Time frame: at time 180 after ingestion in Day 21

Questionnaire of satiety

Questionnaire was composed of 4 questions where satiety was assessed by a 0-10 Numerical Satiety Rating Scale where "0" means to be free from hunger and "10" to be very hungry.

Time frame: at time 0 after ingestion in Day 28

Questionnaire of satiety

Questionnaire was composed of 4 questions where satiety was assessed by a 0-10 Numerical Satiety Rating Scale where "0" means to be free from hunger and "10" to be very hungry.

Time frame: at time 60 after ingestion in Day 28

Questionnaire of satiety

Questionnaire was composed of 4 questions where satiety was assessed by a 0-10 Numerical Satiety Rating Scale where "0" means to be free from hunger and "10" to be very hungry.

Time frame: at time 180 after ingestion in Day 28

Questionnaire of acceptability

Acceptability was assessed by a 7-point time scale where "1" means a very poor acceptability and "7" means a very good acceptability

Time frame: day 0

Questionnaire of acceptability

Acceptability was assessed by a 7-point time scale where "1" means a very poor acceptability and "7" means a very good acceptability

Time frame: day 7

Questionnaire of acceptability

Acceptability was assessed by a 7-point time scale where "1" means a very poor acceptability and "7" means a very good acceptability

Time frame: day 14

Questionnaire of acceptability

Acceptability was assessed by a 7-point time scale where "1" means a very poor acceptability and "7" means a very good acceptability

Time frame: day 21

Questionnaire of acceptability

Acceptability was assessed by a 7-point time scale where "1" means a very poor acceptability and "7" means a very good acceptability

Time frame: day 28

Facilited individual interview

Facilitated interview to assess organoleptic, satiety and gastrointestinal comfort

Time frame: day 40

Focus group

Focus group interview to assess organoleptic, satiety and gastrointestinal comfort

Time frame: day 40