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NCT Number: 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

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.

Recruiting

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Key information

Age range

30 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kajjansi Health Centre IV

Wakiso, Uganda

Location status: Recruiting

Location contact

Fred Kigozi

CONTACT

[email protected]

312210200

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Indigenous Fruit and vegetable.

Other

Indigenous fruit and vegetable freeze dried powder.

Challenge meal that resembles the oral glucose tolerance test.

Other

Isocaloric challenge meal

Primary outcomes

  1. 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

    Blood glucose analysis for blood samples collected at 8 different time points:0, 15, 30, 60, 90, 120, 150 and 180 minutes

Secondary outcomes

  1. 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

    Blood Triglyceride analysis for blood samples collected at 8 different time points:0, 15, 30, 60, 90, 120, 150 and 180 minutes

  2. 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

    Blood HDL analysis for blood samples collected at 8 different time points:0, 15, 30, 60, 90, 120, 150 and 180 minutes

  3. 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

    Blood LDL analysis for blood samples collected at 8 different time points:0, 15, 30, 60, 90, 120, 150 and 180 minutes

  4. 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

    Blood cholestrol analysis for blood samples collected at 8 different time points:0, 15, 30, 60, 90, 120, 150 and 180 minutes

  5. 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

    Plasma polyphenol metabolite analysis for blood samples collected at 8 different time points:0, 15, 30, 60, 90, 120, 150 and 180 minutes

  6. 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

    Appetite visual analog scores analysis at 8 different time points:0, 15, 30, 60, 90, 120, 150 and 180 minutes

  7. 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

    Palatability visual analog scores analysis at one time point:15 minutes

Other outcomes

  1. Body mass Index (BMI)

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

    BMI will be calculated using height and weight

  2. Fat mass

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

    Bioelectrical impedence analysis will be performed

  3. Waist circumference

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

    Wait circumference will be measured using a measuring tape

Study contacts

Contact information is provided by the study sponsor or research team.

Fred Kigozi, MSc

CONTACT

[email protected]

+256701530822

Tonny Kiyimba, PhD

CONTACT

[email protected]

+256706923575

Sponsors and collaborators

Lead sponsor

KU Leuven

Other

Registry information

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Dec 19, 2025
Registry last updated
May 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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