Orange Juice and Glycaemic Control in Type 2 Diabetes Mellitus

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The evidence on the consumption of 100% orange juice in people with type 2 diabetes is highly variable and largely out-of-date, with a few studies reporting acute negative glycaemic effects when 100% orange juice is drunk with or without a meal.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

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

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Other: orange juice concentrate
* Other: Sugar-sweetened orange-flavoured beverage
* Other: Whole orange juice with skin removed


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

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

What is the study measuring?
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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 |