Glycaemic Response, Insulinaemic Response, GLP-1 and GIP Testing of Food Product Lines

Oxford Brookes University41 enrolled

Overview

The aim of this study was to compare the glycaemic response, insulinaemic response, GIP response and GLP-1 response to glucose, 25 g Nutralys S85 Plus and 50 g Nutralys S85 Plus using a single-blind, randomised, repeat measure, crossover design trial.

The aims of this study were to examine: * Phase I - the glycaemic response (GR) and insulinaemic response (IR) to: * 50 g available carbohydrate * 50 g available carbohydrate + protein (dose 1) * 50 g available carbohydrate + protein (dose 2) * Phase II - the GLP-1 and GIP response to: * 50 g available carbohydrate * 50 g available carbohydrate + protein (dose 1) * 50 g available carbohydrate + protein (dose 2) A single-blind, randomised, repeat measure, crossover design trial was used to study the response following consumption of three meals: one reference meal (50 g available carbohydrate) and two test meals (50 g available carbohydrate with protein dose 1 and 50 g available carbohydrate with protein dose 2). The study was conducted in two phases: * Phase I: glycaemic response (GR), insulinaemic response (IR) * Phase II: GLP-1 response and GIP response

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

SINGLE

Enrollment

Conditions

Healthy

Interventions

25 g Nutralys Pea ProteinDIETARY_SUPPLEMENT

To determine the glycaemic response, insulinaemic response, GIP response and GLP-1 response to 50g Glucose +25g Nutralys S85 Plus

50 g Nutralys S85 Plus.DIETARY_SUPPLEMENT

To determine the glycaemic response, insulinaemic response, GIP response and GLP-1 response to 50g Glucose+50 g Nutralys S85 Plus .

50 g GlucoseDIETARY_SUPPLEMENT

To determine the glycaemic response, insulinaemic response, GIP response and GLP-1 response to 50g Glucose

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Aged 18 to 60 years * Body mass index (BMI) less than 30kg/m2 Exclusion Criteria: * Pregnant or lactating * Fasting blood glucose value \> 6.1 mmol/l * Any known food allergy or intolerance * Medical condition(s) or medication(s) known to affect glucose regulation or appetite and/or which influence digestion and absorption of nutrients * Known history of diabetes mellitus or the use of antihyperglycaemic drugs or insulin to treat diabetes and related conditions * Major medical or surgical event requiring hospitalization within the preceding 3 months * Use of steroids, protease inhibitors or antipsychotics (all of which have major effects on glucose metabolism and body fat distribution). * Unable to comply with experimental procedures or did not follow GR testing safety guidelines.

Locations (1)

Oxford Brookes Centre for Nutrition and Health

Oxford, United Kingdom

Outcomes

Primary Outcomes

Change in blood glucose response from baseline for 3 hours

Change in postprandial blood glucose response from baseline was measured at 15 min, 30 min, 45 min, 1 hour, 1.5 hours, 2 hours, 2.5 hours and 3 hours

Time frame: 3 hours

Change in plasma insulin response from baseline for 3 hours

Change in postprandial plasma insulin response from baseline was measured at 15 min, 30 min, 45 min, 1 hour, 1.5 hours, 2 hours, 2.5 hours and 3 hours

Time frame: 3 hours

Area under the blood glucose concentration versus time curve

Area under the blood glucose concentration versus time curve was calculated by trapezoidal rule

Time frame: 3 hours

Area under the plasma insulin concentration versus time curve

Area under the plasma insulin concentration versus time curve was calculated by trapezoidal rule

Time frame: 3 hours

Peak blood glucose concentration (Cmax)

Peak blood glucose concentration (Cmax) after consumption of the test food

Time frame: 0-3 hours

Peak plasma insulin concentration (Cmax)

Peak plasma insulin concentration (Cmax) after consumption of the test food

Time frame: 0-3 hours

Time of blood glucose peak (Tmax)

Time of blood glucose peak after consumption of the test food

Time frame: 0-3 hours

Time of plasma insulin peak (Tmax)

Time of plasma insulin peak after consumption of the test food

Data from ClinicalTrials.gov

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Secondary Outcomes

Change in GLP-1 from baseline for 3 hours

Change in GLP-1 from baseline was measured at 15 min, 30 min, 45 min, 1 hour, 1.5 hours, 2 hours, 2.5 hours and 3 hours

Time frame: 3 hours

Change in GIP from baseline for 3 hours

Change in GIP from baseline was measured at 15 min, 30 min, 45 min, 1 hour, 1.5 hours, 2 hours, 2.5 hours and 3 hours

Time frame: 3 hours

Area under the plasma GLP-1 concentration versus time curve

Area under the plasma GLP-1 concentration versus time curve was calculated by trapezoidal rule

Time frame: 3 hours

Area under the plasma GIP concentration versus time curve

Area under the plasma GIP concentration versus time curve was calculated by trapezoidal rule

Time frame: 3 hours

Peak plasma GLP-1 concentration (Cmax)

Peak plasma GLP-1 concentration (Cmax) after consumption of the test food

Time frame: 0-3 hours

Peak plasma GIP concentration (Cmax)

Peak plasma GIP concentration (Cmax) after consumption of the test food

Time frame: 0-3 hours

Time of plasma GLP-1 peak (Tmax)

Time of plasma GLP-1 peak after consumption of the test food

Time frame: 0-3 hours

Time of plasma GIP peak (Tmax)

Time of plasma GIP peak after consumption of the test food

Time frame: 0-3 hours