Orange Juice and Glycaemic Control in Type 2 Diabetes Mellitus

Not Applicable

Completed

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Other: Sugar-sweetened orange-flavoured beverage; Other: orange juice concentrate; Other: Whole orange juice with skin removed

• Registration Number: NCT04412798
• Lead Sponsor: Hasselt University

Brief Summary

The evidence on the consumption of 100% orange juice in people with type 2 diabetes is highly variable and largely out-of-date, with a few studies reporting acute negative glycaemic effects when 100% orange juice is drunk with or without a meal.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

Detailed Description

Not available

Study Timeline

• Study Start: 2020-05-01
• Study First Submitted: 2020-05-29
• Study First Submitted QC: 2020-06-01
• Study First Posted: 2020-06-02
• Primary Completion: 2024-04-01
• Study Completion: 2024-04-01
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-16
• Last Update Posted: 2024-05-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Group 2	Sugar-sweetened orange-flavoured beverage	Sugar-sweetened orange-flavoured beverage
group 1	orange juice concentrate	orange juice concentrate
Group 3	Whole orange juice with skin removed	Whole orange juice with skin removed

Primary Outcome Measures

Name	Time	Method
Insulin responses	Day 10	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.
Glycaemic responses venous blood	Day 10	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.
Capillary glycaemic responses	Day 10	Capillary blood samples collected to examine glycemia before, during and after a breakfast (differing in supplemented juice composition) for up to 5 hours postprandial.

Secondary Outcome Measures

Name	Time	Method
Flow cytometry	Baseline	Fasting venous blood samples collected to examine Peripheral blood mononuclear cells (flow cytometry) to measure immunological parameters
Systolic/diastolic blood pressure	Baseline	Systolic/diastolic blood pressure
Glycated haemoglobin measure	Baseline	Measured on a single blood sample to characterize patients' overall glycaemic contro
Alzheimer disease related biomarkers	Baseline	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)
Waist/hip circumference (Body composition)	Baseline	Waist/hip circumference
BMI	Baseline	body weight/height (to determine BMI)

Trial Locations

Locations (1)

Hasselt University; 🇧🇪 Hasselt, Belgium