MedDataX Logo

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

NCT ID: NCT07295600

Last Updated: 2025-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-02-01

Study Completion Date

2026-03-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Type 2 Diabetes Cardiometabolic Health

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Challenge meal enriched with Hibiscus sabdariffa (Hibiscus)

Group Type EXPERIMENTAL

Indigenous Fruit and vegetable.

Intervention Type OTHER

Indigenous fruit and vegetable freeze dried powder.

Challenge meal enriched with Solunum anguivi (Forest bitter berries)

Group Type EXPERIMENTAL

Indigenous Fruit and vegetable.

Intervention Type OTHER

Indigenous fruit and vegetable freeze dried powder.

Challenge meal enriched withTamarindus indica (Tamarind)

Group Type EXPERIMENTAL

Indigenous Fruit and vegetable.

Intervention Type OTHER

Indigenous fruit and vegetable freeze dried powder.

Reference meal one

Group Type ACTIVE_COMPARATOR

Challenge meal that resembles the oral glucose tolerance test.

Intervention Type OTHER

Isocaloric challenge meal

Reference meal two

Group Type ACTIVE_COMPARATOR

Challenge meal that resembles the oral glucose tolerance test.

Intervention Type OTHER

Isocaloric challenge meal

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Indigenous Fruit and vegetable.

Indigenous fruit and vegetable freeze dried powder.

Intervention Type OTHER

Challenge meal that resembles the oral glucose tolerance test.

Isocaloric challenge meal

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

30 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

KU Leuven

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Christophe Matthys

Proffessor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Christophe Matthys, Phd

Role: PRINCIPAL_INVESTIGATOR

KU Leuven University, Belgium

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Tonny Kiyimba, PhD

Role: CONTACT

Phone: +256706923575

Email: [email protected]

Fred Kigozi, MSc

Role: CONTACT

Phone: +256701530822

Email: [email protected]

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Postprandial studies

Identifier Type: -

Identifier Source: org_study_id