Orange Juice and Glycaemic Control in Type 2 Diabetes Mellitus

NCT04412798 | Completed

• 1 other identifier: Orange -Juice-001
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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The evidence on the consumption of 100% orange juice in people with type 2 diabetes is highly variable and largely out-of-date, with a few studies reporting acute negative glycaemic effects when 100% orange juice is drunk with or without a meal.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

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (9)

• 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 Outcomes (6)

• Glycated haemoglobin measure

  Baseline

• Flow cytometry

  Baseline

• Alzheimer disease related biomarkers

  Baseline

• BMI

  Baseline

• Waist/hip circumference (Body composition)

  Baseline

Study Arms (3)

group 1

OTHER

orange juice concentrate

Other: orange juice concentrate

Group 2

OTHER

Sugar-sweetened orange-flavoured beverage

Other: Sugar-sweetened orange-flavoured beverage

Group 3

OTHER

Whole orange juice with skin removed

Other: Whole orange juice with skin removed

Interventions

orange juice concentrate OTHER

250mL of 100% orange juice made from concentrate

group 1

Sugar-sweetened orange-flavoured beverage OTHER

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

Group 2

Whole orange juice with skin removed OTHER

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

Group 3

Eligibility Criteria

• Age: 25 Years - 75 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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

Sponsors & Collaborators

• Hasselt University: lead
• Hochschule Geisenheim University: collaborator

Study Sites (1)

Hasselt University

Hasselt, 3500, Belgium

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Dominique Hansen, prof. dr.

  Hasselt University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 29, 2020
• First Posted: June 2, 2020
• Study Start: May 1, 2020
• Primary Completion: April 1, 2024
• Study Completion: April 1, 2024
• Last Updated: May 17, 2024

Record last verified: 2024-05

Locations

BE (1)