Cardiometabolic Health, Type 2 Diabetes
Conditions
Keywords
Type 2 diabetes, Challenge meals, Postprandial, Glucose metabolism, Indigenous fruits and Vegetables
Brief summary
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.
Detailed description
In a postprandial study, cardiometabolic health outcomes will be assessed on each 3-hour test day, comprising the consumption of one challenge meal enriched with any of the three indigenous fruits and vegetables. The three indigenous fruits and vegetables will include: Hibiscus sabdariffa (Hibiscus), Solanum anguivi (Forest bitter berries), and Tamarindus indica (Tamarind). A preliminary sensory evaluation involving the freeze-dried indigenous fruits and vegetable powder prototypes was conducted. The prototypes were formulated based on fruit pulp, vegetable and calyx proportions (25g, 50g and 100g). The prototypes were subjected to a sensory evaluation (acceptability and preference tests) using untrained panellists (n = 10). After the sensory study, the 25g prototypes had the highest scores. However, due to variation in polyphenol profiles in the three indigenous fruits and vegetable powders, the 50g prototypes were selected to ensure an adequate polyphenol dose. The study participants will be randomly allocated to consume one challenge meal enriched with one of the three indigenous fruit and vegetable-based powders on each study day. There will be an additional two reference challenge meals administered to determine within-subject variability. A 5 to 7-day washout period will be observed between each postprandial study to prevent any carryover effect. The participants in the study will not be informed of the ingredients in the challenge meals. The total study duration will be 5 weeks. Measurements will be performed on each study visit.
Interventions
OTHERIndigenous Fruit and vegetable.
Indigenous fruit and vegetable freeze dried powder.
OTHERChallenge meal that resembles the oral glucose tolerance test.
Isocaloric challenge meal
Sponsors
KU Leuven
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
30 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* Taking dietary supplements * Type 1 diabetes * Tuberculosis co-infection * Renal failure * Liver cirrhosis * Chronic pancreatitis * Pregnancy and Lactation * Regular sports activity * Parallel participation in another clinical trial * On treatment for dyslipidaemia, * On treatment for hypertension * Very low blood pressure (\< 90/50 mmHg) * Allergic reactions to test products
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incremental area under the curve blood glucose | From enrollment at each of the five postprandial visits, until the end of the postprandial study which will last five weeks | Blood glucose analysis for blood samples collected at 8 different time points:0, 15, 30, 60, 90, 120, 150 and 180 minutes |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incremental area under the curve blood triglyceride | From enrollment at each of the five postprandial visits, until the end of the postprandial study which will last five weeks | Blood Triglyceride analysis for blood samples collected at 8 different time points:0, 15, 30, 60, 90, 120, 150 and 180 minutes |
| Incremental area under the curve high density lipoprotein cholestrol (HDL) | From enrollment at each of the five postprandial visits, until the end of the postprandial study which will last five weeks | Blood HDL analysis for blood samples collected at 8 different time points:0, 15, 30, 60, 90, 120, 150 and 180 minutes |
| Incremental area under the curve low density lipoprotein cholestrol (LDL) | From enrollment at each of the five postprandial visits, until the end of the postprandial study which will last five weeks | Blood LDL analysis for blood samples collected at 8 different time points:0, 15, 30, 60, 90, 120, 150 and 180 minutes |
| Incremental area under the curve total cholestrol | From enrollment at each of the five postprandial visits, until the end of the postprandial study which will last five weeks | Blood cholestrol analysis for blood samples collected at 8 different time points:0, 15, 30, 60, 90, 120, 150 and 180 minutes |
| Incremental area under the curve plasma polyphenol metabolites | From enrollment at each of the five postprandial visits, until the end of the postprandial study which will last five weeks | Plasma polyphenol metabolite analysis for blood samples collected at 8 different time points:0, 15, 30, 60, 90, 120, 150 and 180 minutes |
| Incremental area under the curve appetite visual analog scores | From enrollment at each of the five postprandial visits, until the end of the postprandial study which will last five weeks | Appetite visual analog scores analysis at 8 different time points:0, 15, 30, 60, 90, 120, 150 and 180 minutes |
| Palatability visual analog scores | From enrollment at each of the five postprandial visits, until the end of the postprandial study which will last five weeks | Palatability visual analog scores analysis at one time point:15 minutes |
Countries
Uganda
Contacts
PRINCIPAL_INVESTIGATORChristophe Matthys, Phd
KU Leuven University, Belgium
Outcome results
None listed