Orange Juice and Glycaemic Control in Type 2 Diabetes Mellitus

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04412798
• Other study ID #: Orange -Juice-001
• Status: Completed
• Phase: N/A
• Start date: May 1, 2020
• Est. completion date: April 1, 2024

Study information

• Verified date: May 2024
• Source: Hasselt University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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The evidence on the consumption of 100% orange juice in people with type 2 diabetes is highly variable and largely out-of-date, with a few studies reporting acute negative glycaemic effects when 100% orange juice is drunk with or without a meal.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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: April 1, 2024
• Est. primary completion date: April 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Other:
• orange juice concentrate
250mL of 100% orange juice made from concentrate
• Sugar-sweetened orange-flavoured beverage
Sugar-sweetened orange-flavoured beverage, energy-matched to the orange juice condition
• Whole orange juice with skin removed
Whole orange pieces with skin removed, energy-matched to the orange juice condition

Locations

Country	Name	City	State
Belgium	Hasselt University	Hasselt

Sponsors (2)

Lead Sponsor	Collaborator
Hasselt University	Hochschule Geisenheim University

Country where clinical trial is conducted

Belgium, 

Outcome

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