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

NCT07295600 | Not Yet Recruiting

• 1 other identifier: Postprandial studies
• Study Type: interventional
• Target: 8
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Type 2 Diabetes; Cardiometabolic Health

Keywords

Type 2 diabetes; Challenge meals; Postprandial; Glucose metabolism; Indigenous fruits and Vegetables

Outcome Measures

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

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

Secondary Outcomes (6)

• 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

• 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

• 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

• 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

• 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

Other Outcomes (3)

• Body mass Index (BMI)

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

• Fat mass

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

• Waist circumference

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

Study Arms (5)

Challenge meal enriched with Hibiscus sabdariffa (Hibiscus)

EXPERIMENTAL

Other: Indigenous Fruit and vegetable.

Challenge meal enriched with Solunum anguivi (Forest bitter berries)

EXPERIMENTAL

Other: Indigenous Fruit and vegetable.

Challenge meal enriched withTamarindus indica (Tamarind)

EXPERIMENTAL

Other: Indigenous Fruit and vegetable.

Reference meal one

ACTIVE COMPARATOR

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

Reference meal two

ACTIVE COMPARATOR

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

Interventions

Indigenous Fruit and vegetable. OTHER

Indigenous fruit and vegetable freeze dried powder.

Challenge meal enriched with Hibiscus sabdariffa (Hibiscus); Challenge meal enriched with Solunum anguivi (Forest bitter berries); Challenge meal enriched withTamarindus indica (Tamarind)

Challenge meal that resembles the oral glucose tolerance test. OTHER

Isocaloric challenge meal

Reference meal one; Reference meal two

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• KU Leuven: lead

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Vegetables

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Christophe Matthys, Phd

  KU Leuven University, Belgium

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tonny Kiyimba, PhD

CONTACT

+256706923575; tonny.kiyimba1@gmail.com

Fred Kigozi, MSc

CONTACT

+256701530822; fred.kigozi49@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Proffessor

Study Record Dates

• First Submitted: December 3, 2025
• First Posted: December 19, 2025
• Study Start (Estimated): May 13, 2026
• Primary Completion (Estimated): July 30, 2026
• Study Completion (Estimated): July 30, 2026
• Last Updated: May 6, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: 9 to 18 months after article publication.