Health TrialsbyHealthPanel

Postprandial Effect of Isocaloric Challenge Meals Enriched With Indigenous Fruits and Vegetables on Glucose Metabolism in Individuals With Type 2 Diabetes in Wakiso District, Uganda

ConditionsType 2 DiabetesCardiometabolic Health
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age30-60
SponsorKU Leuven

About this trial

The goal of this clinical trial is to evaluate changes in glucose and lipid levels after consuming challenge meals enriched with selected indigenous fruits and vegetables in people living with type 2 diabetes in Wakiso district.

The main question to answer is:

Does the consumption of challenge meals enriched with indigenous fruits and vegetables improve glucose and lipid levels among people living with type 2 diabetes? Researchers will compare the effects of different challenge meals on glucose and lipid levels to identify the indigenous fruit and vegetable with the strongest glucose- and lipid-lowering effects.

Participants will:

Consume five challenge meals over 5 weeks. Visit the study site after a 5-7 day rest period to consume the challenge meal and complete the tests.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Fasting blood sugar >= [7 mmol/L](based on medical records)

Diabetic regimen for at least 6 months

Type 2 diabetes

Plans to continue staying in the same location for the next 6 months

Disqualifiers

Taking dietary supplements

Type 1 diabetes

Tuberculosis co-infection

Renal failure

Trial design

Design model

Crossover

Treatments tested in this trial

  • Indigenous Fruit and vegetable.

    Other intervention

    Indigenous fruit and vegetable freeze dried powder.

  • Challenge meal that resembles the oral glucose tolerance test.

    Other intervention

    Isocaloric challenge meal

Treatment groups

8 Participants
are divided into 5 treatment groups
Group A: Challenge meal enriched with Hibiscus sabdariffa (Hibiscus)Experimental treatment 1 intervention
Group B: Challenge meal enriched with Solunum anguivi (Forest bitter berries)Experimental treatment 1 intervention
Group C: Challenge meal enriched withTamarindus indica (Tamarind)Experimental treatment 1 intervention
Group D: Reference meal oneActive comparator 1 intervention
Group E: Reference meal twoActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Incremental area under the curve blood glucose

Blood glucose analysis for blood samples collected at 8 different time points:0, 15, 30, 60, 90, 120, 150 and 180 minutes

Time frame
From enrollment at each of the five postprandial visits, until the end of the postprandial study which will last five weeks

Secondary outcomes

1

Incremental area under the curve blood triglyceride

Blood Triglyceride analysis for blood samples collected at 8 different time points:0, 15, 30, 60, 90, 120, 150 and 180 minutes

Time frame
From enrollment at each of the five postprandial visits, until the end of the postprandial study which will last five weeks
2

Incremental area under the curve high density lipoprotein cholestrol (HDL)

Blood HDL analysis for blood samples collected at 8 different time points:0, 15, 30, 60, 90, 120, 150 and 180 minutes

Time frame
From enrollment at each of the five postprandial visits, until the end of the postprandial study which will last five weeks
3

Incremental area under the curve low density lipoprotein cholestrol (LDL)

Blood LDL analysis for blood samples collected at 8 different time points:0, 15, 30, 60, 90, 120, 150 and 180 minutes

Time frame
From enrollment at each of the five postprandial visits, until the end of the postprandial study which will last five weeks
4

Incremental area under the curve total cholestrol

Blood cholestrol analysis for blood samples collected at 8 different time points:0, 15, 30, 60, 90, 120, 150 and 180 minutes

Time frame
From enrollment at each of the five postprandial visits, until the end of the postprandial study which will last five weeks

Other outcomes

1

Body mass Index (BMI)

BMI will be calculated using height and weight

Time frame
BMI will be calculated only on day one of the study that lasts five weeks
2

Fat mass

Bioelectrical impedence analysis will be performed

Time frame
Fat mass will be calculated only on day one of the study that lasts five weeks
3

Waist circumference

Wait circumference will be measured using a measuring tape

Time frame
Waist circumference will be calculated only on day one of the study that lasts five weeks

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

KU Leuven

Lead sponsor

Source ClinicalTrials.gov
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