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

Catholic University (KU) of Leuven

Status: Not yet enrolling

Conditions: Cardiometabolic Health; Type 2 Diabetes

Treatments: Other: Challenge meal that resembles the oral glucose tolerance test.; Other: Indigenous Fruit and vegetable.

Study type: Interventional

Funder types: Other

Identifiers

NCT07295600

Postprandial studies

Details and patient eligibility

About

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.

Full 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 vegetable based powders. The study participants will be randomly allocated to consume one challenge meal enriched with one of the three indigenous fruits and vegetable based powders on each study day. The indigenous fruits and vegetable based powders will contain a dose of 760 mg of total polyphenol. The three indigenous fruits and vegetable will include: Hibiscus sabdariffa (Hibiscus), Solunum anguivi (Forest bitter berries), and Tamarindus indica (Tamarind). 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.

Enrollment: 8 estimated patients

Sex: All

Ages: 30 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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8 participants in 5 patient groups

Challenge meal enriched with Hibiscus sabdariffa (Hibiscus)

Experimental group

Treatment:

Other: Indigenous Fruit and vegetable.

Challenge meal enriched with Solunum anguivi (Forest bitter berries)

Experimental group

Treatment:

Other: Indigenous Fruit and vegetable.

Challenge meal enriched withTamarindus indica (Tamarind)

Experimental group

Treatment:

Other: Indigenous Fruit and vegetable.

Reference meal one

Active Comparator group

Treatment:

Other: Challenge meal that resembles the oral glucose tolerance test.

Reference meal two

Active Comparator group

Treatment:

Other: Challenge meal that resembles the oral glucose tolerance test.