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CompletedNCT04412798Updated May 17, 2024

Orange Juice and Glycaemic Control in Type 2 Diabetes Mellitus

An interventional study of orange juice concentrate and Sugar-sweetened orange-flavoured beverage in Diabetes Mellitus, Type 2, sponsored by Hasselt University. Completed at 1 site in Belgium. Open to participants aged 25 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-05-17.

Sponsored by Hasselt University · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
15
Allocation
Randomized
Ages
25 Years to 75 Years
Sex
All
01

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The evidence on the consumption of 100% orange juice in people with type 2 diabetes is highly variable and largely out-of-date, with a few studies reporting acute negative glycaemic effects when 100% orange juice is drunk with or without a meal.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

02

Conditions studied

  • Diabetes Mellitus, Type 2
03

In context

Diabetes Mellitus, Type 2

9,589 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,332 are open to participants now.

This study's enrollment of 15 is below the median of 81 across 7,713 interventional studies indexed under Diabetes Mellitus, Type 2.

Browse Diabetes Mellitus, Type 2 studies →

Lead sponsor

Hasselt University is the lead sponsor of 203 studies on the registry; 31 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
25 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
15 participants (actual)

Study arms

  • Other
    group 1

    orange juice concentrate

    Other: orange juice concentrate

  • Other
    Group 2

    Sugar-sweetened orange-flavoured beverage

    Other: Sugar-sweetened orange-flavoured beverage

  • Other
    Group 3

    Whole orange juice with skin removed

    Other: Whole orange juice with skin removed

Interventions

  • Otherorange juice concentrate

    250mL of 100% orange juice made from concentrate

  • OtherSugar-sweetened orange-flavoured beverage

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

  • OtherWhole orange juice with skin removed

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

06

What researchers measure

Primary outcomes

  1. 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

  2. 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: Day 5

  3. 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: Day 10

  4. 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

  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.

    Time frame: Day 5

  6. 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: Day 10

  7. 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.

    Time frame: Baseline

  8. 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.

    Time frame: Day 5

  9. 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.

    Time frame: Day 10

Secondary outcomes

  1. Glycated haemoglobin measure

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

    Time frame: Baseline

  2. Flow cytometry

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

    Time frame: Baseline

  3. 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

  4. BMI

    body weight/height (to determine BMI)

    Time frame: Baseline

  5. Waist/hip circumference (Body composition)

    Waist/hip circumference

    Time frame: Baseline

  6. Systolic/diastolic blood pressure

    Systolic/diastolic blood pressure

    Time frame: Baseline

07

Study locations

1 site
  • Hasselt University
    Hasselt, 3500, Belgium
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 17, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04412798
Lead sponsor
Hasselt University
Collaborators
Hochschule Geisenheim University
Responsible party
Dominique Hansen (Principal Investigator, Hasselt University) — Principal investigator
First posted
Jun 2, 2020
Start date
May 1, 2020
Primary completion
Apr 1, 2024
Completion
Apr 1, 2024
Last update
May 17, 2024

Study contacts

Dominique Hansen, prof. dr.
principal investigator · Hasselt University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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