Diabetes Mellitus, Type 2
Conditions
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The evidence on the consumption of 100% orange juice in people with type 2 diabetes is highly variable and largely out-of-date, with a few studies reporting acute negative glycaemic effects when 100% orange juice is drunk with or without a meal.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
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
Sponsors
Hochschule Geisenheim University
Hasselt University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
25 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Glycaemic responses venous blood | 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. |
| Insulin responses | 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. |
| Capillary glycaemic responses | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| BMI | Baseline | body weight/height (to determine BMI) |
| Glycated haemoglobin measure | Baseline | Measured on a single blood sample to characterize patients' overall glycaemic contro |
| Systolic/diastolic blood pressure | Baseline | Systolic/diastolic blood pressure |
| Waist/hip circumference (Body composition) | Baseline | Waist/hip circumference |
| Flow cytometry | Baseline | Fasting venous blood samples collected to examine Peripheral blood mononuclear cells (flow cytometry) to measure immunological parameters |
| Alzheimer disease related biomarkers | 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) |
Countries
Belgium
Outcome results
None listed