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Completed

NCT Number: NCT04412798

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The evidence on the consumption of 100% orange juice in people with type 2 diabetes is highly variable and largely out-of-date, with a few studies reporting acute negative glycaemic effects when 100% orange juice is drunk with or without a meal.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

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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

25 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hasselt University

Hasselt, 3500, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

orange juice concentrate

Other

250mL of 100% orange juice made from concentrate

Sugar-sweetened orange-flavoured beverage

Other

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

Whole orange juice with skin removed

Other

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

Primary outcomes

  1. Glycaemic responses venous blood

    Time frame: baseline

    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.

  2. Glycaemic responses venous blood

    Time frame: Day 5

    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.

  3. Glycaemic responses venous blood

    Time frame: 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.

  4. Insulin responses

    Time frame: Baseline

    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.

  5. Insulin responses

    Time frame: Day 5

    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.

  6. Insulin responses

    Time frame: 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.

  7. Capillary glycaemic responses

    Time frame: Baseline

    Capillary blood samples collected to examine glycemia before, during and after a breakfast (differing in supplemented juice composition) for up to 5 hours postprandial.

  8. Capillary glycaemic responses

    Time frame: Day 5

    Capillary blood samples collected to examine glycemia before, during and after a breakfast (differing in supplemented juice composition) for up to 5 hours postprandial.

  9. Capillary glycaemic responses

    Time frame: 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 outcomes

  1. Glycated haemoglobin measure

    Time frame: Baseline

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

  2. Flow cytometry

    Time frame: Baseline

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

  3. Alzheimer disease related biomarkers

    Time frame: 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)

  4. BMI

    Time frame: Baseline

    body weight/height (to determine BMI)

  5. Waist/hip circumference (Body composition)

    Time frame: Baseline

    Waist/hip circumference

  6. Systolic/diastolic blood pressure

    Time frame: Baseline

    Systolic/diastolic blood pressure

Sponsors and collaborators

Lead sponsor

Hasselt University

Other

Collaborators

  • Hochschule Geisenheim University

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Jun 2, 2020
Registry last updated
May 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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