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
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Indigenous Fruit and vegetable., Challenge meal that resembles the oral glucose tolerance test..
- Who it may be relevant to
- Registry conditions: Type 2 Diabetes, Cardiometabolic Health. Basic parameters: 30 years — 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Uganda
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
- Other Indigenous Fruit and vegetable.
Indigenous fruit and vegetable freeze dried powder. - Other Challenge meal that resembles the oral glucose tolerance test.
Isocaloric challenge meal
Primary outcome measures
- Incremental area under the curve blood glucose [Time frame: From enrollment at each of the five postprandial visits, until the end of the postprandial study which will last five weeks]
Secondary outcome measures (7)
- Incremental area under the curve blood triglyceride [Time frame: From enrollment at each of the five postprandial visits, until the end of the postprandial study which will last five weeks]
- Incremental area under the curve high density lipoprotein cholestrol (HDL) [Time frame: From enrollment at each of the five postprandial visits, until the end of the postprandial study which will last five weeks]
- Incremental area under the curve low density lipoprotein cholestrol (LDL) [Time frame: From enrollment at each of the five postprandial visits, until the end of the postprandial study which will last five weeks]
- Incremental area under the curve total cholestrol [Time frame: From enrollment at each of the five postprandial visits, until the end of the postprandial study which will last five weeks]
- Incremental area under the curve plasma polyphenol metabolites [Time frame: From enrollment at each of the five postprandial visits, until the end of the postprandial study which will last five weeks]
- Incremental area under the curve appetite visual analog scores [Time frame: 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 [Time frame: From enrollment at each of the five postprandial visits, until the end of the postprandial study which will last five weeks]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Uganda · 1 center
- Kajjansi Health Centre IV — Wakiso
Identifiers
NCT: NCT07295600 · Postprandial studies