NCT07295600

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 8 (estimated)
• Sponsor: KU Leuven · Academic / Other
• Sex: All
• Age: 30 Years – 60 Years
• Healthy volunteers: Not accepted

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 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.

Conditions

• Type 2 Diabetes
• Cardiometabolic Health

Interventions

Type	Name	Description
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

Timeline

• Start date: 2026-02-01
• Primary completion: 2026-03-30
• Completion: 2026-03-30
• First posted: 2025-12-19
• Last updated: 2025-12-19