Orange Juice and Glycaemic Control in Type 2 Diabetes Mellitus

Hasselt University15 enrolled

Overview

The evidence on the consumption of 100% orange juice in people with type 2 diabetes is highly variable and largely out-of-date, with a few studies reporting acute negative glycaemic effects when 100% orange juice is drunk with or without a meal. The aim of the project is to study the impact of the intake of a single serving of 100% orange juice on glycaemic control in male patients with pre-existing type 2 diabetes mellitus. In addition, immunological parameters and Alzheimer disease related biomarkers will be assessed to examine the chronic inflammatory state of these patients

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

DOUBLE

Enrollment

Conditions

Diabetes Mellitus, Type 2

Interventions

orange juice concentrateOTHER

250mL of 100% orange juice made from concentrate

Sugar-sweetened orange-flavoured beverageOTHER

Sugar-sweetened orange-flavoured beverage, energy-matched to the orange juice condition

Whole orange juice with skin removedOTHER

Whole orange pieces with skin removed, energy-matched to the orange juice condition

Eligibility

Sex: ALLMin age: 25 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Inclusion Criteria: individuals (aged 25-75 years) with up to 8 years of T2DM, according to ADA criteria (Two-hour plasma glucose ≥200 mg/dL (11.1 mmol/L) during OGTT. The test should be performed as described by the WHO, using a glucose load containing the equivalent of 75-g anhydrous glucose dissolved in water; or HbA1c \> ≥6.5% (48 mmol/mol)). Exclusion Criteria: * pregnancy, * participants on exogenous insulin therapy, * HbA1c \>8.5%, * BMI \<22 or \>35 kg/m², * regular smokers (\>1 cigarette per day), * participants with established cardiovascular disease, * neurological disease, * cancer, * renal disease. * Participants who are unwilling to consume any of the standard foods/drinks

Locations (1)

Hasselt University

Hasselt, Belgium

Outcomes

Primary Outcomes

Glycaemic responses venous blood

Venous blood samples collected to examine systemic glycemia (venous blood glucose concentration (mg/dL)) before, during and after a breakfast (differing in supplemented juice composition) for up to 5 hours postprandial.

Time frame: baseline

Glycaemic responses venous blood

Time frame: Day 5

Glycaemic responses venous blood

Time frame: Day 10

Insulin responses

Venous blood samples collected to examine systemic insulinemia (venous blood insulin concentration (pmol/L)) before, during and after a breakfast (differing in supplemented juice composition) for up to 5 hours postprandial.

Time frame: Baseline

Insulin responses

Time frame: Day 5

Insulin responses

Time frame: Day 10

Data from ClinicalTrials.gov

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Secondary Outcomes

Glycated haemoglobin measure

Measured on a single blood sample to characterize patients' overall glycaemic contro

Time frame: Baseline

Flow cytometry

Fasting venous blood samples collected to examine Peripheral blood mononuclear cells (flow cytometry) to measure immunological parameters

Time frame: Baseline

Alzheimer disease related biomarkers

Blood samples will be collected every 30 min for 5 hours to examine Alzheimer disease relevant biomarkers (Abeta42, Abeta40, Tau, p-Tau, neuroinflammatory markers and other)

Time frame: Baseline

BMI

body weight/height (to determine BMI)

Time frame: Baseline

Waist/hip circumference (Body composition)

Waist/hip circumference

Time frame: Baseline

Systolic/diastolic blood pressure

Time frame: Baseline