Orange Juice and Glycaemic Control in Type 2 Diabetes Mellitus

Impact of Orange Juice During Breakfast on Glycaemic Control in Individuals With Type 2 Diabetes Mellitus

The evidence on the consumption of 100% orange juice in people with type 2 diabetes is highly variable and largely out-of-date, with a few studies reporting acute negative glycaemic effects when 100% orange juice is drunk with or without a meal.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

• Status: Unknown
• Conditions: Diabetes Mellitus, Type 2
• Intervention / Treatment: Other: orange juice concentrate; Other: Sugar-sweetened orange-flavoured beverage; Other: Whole orange juice with skin removed

• Study Type: Interventional
• Enrollment (Anticipated): 18
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dominique Hansen, prof. dr.; Phone Number: +32 11 29 21 26; Email: dominique.hansen@uhasselt.be
• Study Contact Backup: Name: Kenneth Verboven, dr.; Phone Number: +32 11 28 69 49; Email: kenneth.verboven@uhasselt.be

Study Locations

• Belgium
  • Hasselt, Belgium, 3500
    • Recruiting
    • Hasselt University
    • Contact: Dominique Hansen, prof. dr.; Phone Number: +32 11 29 21 26; Email: dominique.hansen@uhasselt.be
    • Principal Investigator: Dominique Hansen, prof. dr.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• Inclusion Criteria: Male individuals (aged 25-65 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:

• participants on exogenous insulin therapy,
• HbA1c >8.5%,
• BMI <27 or >33 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: group 1; orange juice concentrate	Other: orange juice concentrate; 250mL of 100% orange juice made from concentrate
Other: Group 2; Sugar-sweetened orange-flavoured beverage	Other: Sugar-sweetened orange-flavoured beverage; Sugar-sweetened orange-flavoured beverage, energy-matched to the orange juice condition
Other: Group 3; Whole orange juice with skin removed	Other: Whole orange juice with skin removed; Whole orange pieces with skin removed, energy-matched to the orange juice condition

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	baseline
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.	Day 5
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.	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.	Baseline
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.	Day 5
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.	Day 10
Capillary glycaemic responses	Capillary blood samples collected to examine glycemia before, during and after a breakfast (differing in supplemented juice composition) for up to 5 hours postprandial.	Baseline
Capillary glycaemic responses	Capillary blood samples collected to examine glycemia before, during and after a breakfast (differing in supplemented juice composition) for up to 5 hours postprandial.	Day 5
Capillary glycaemic responses	Capillary blood samples collected to examine glycemia before, during and after a breakfast (differing in supplemented juice composition) for up to 5 hours postprandial.	Day 10

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Hasselt University
• Collaborators: Hochschule Geisenheim University

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2020
• Primary Completion (Anticipated): June 30, 2021
• Study Completion (Anticipated): June 30, 2021

Study Registration Dates

• First Submitted: May 29, 2020
• First Submitted That Met QC Criteria: June 1, 2020
• First Posted (Actual): June 2, 2020

Study Record Updates

• Last Update Posted (Actual): December 30, 2020
• Last Update Submitted That Met QC Criteria: December 28, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: Orange -Juice-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No