Type 2 DiabetesNCT07295600
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
A study testing Indigenous Fruit and vegetable. and Challenge meal that resembles the oral glucose tolerance test. in people with Type 2 Diabetes and Cardiometabolic Health, run by KU Leuven at 1 site in Uganda.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 60 years
- Conditions the study is for
- Type 2 Diabetes, Cardiometabolic Health
- What is being tested?
- Indigenous Fruit and vegetable. and Challenge meal that resembles the oral glucose tolerance test.
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUganda
- Study dates
- 18 May 2026to 17 Aug 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- Taking dietary supplements
- Type 1 diabetes
- Tuberculosis co-infection
- Renal failure
- Liver cirrhosis
- Chronic pancreatitis
Show all 13Show fewer
- 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 locations and contacts
1 site in 1 country.
About this study
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:
Read more
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.
Read the 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 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.
- Conditions
- Type 2 Diabetes, Cardiometabolic Health
- Being tested
- Indigenous Fruit and vegetable., Challenge meal that resembles the oral glucose tolerance test.
- Keywords
- Type 2 diabetes, Challenge meals, Postprandial, Glucose metabolism, Indigenous fruits and Vegetables
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| Challenge meal enriched with Hibiscus sabdariffa (Hibiscus) | Experimental | Not described Receives: Other: Indigenous Fruit and vegetable. |
| Challenge meal enriched with Solunum anguivi (Forest bitter berries) | Experimental | Not described Receives: Other: Indigenous Fruit and vegetable. |
| Challenge meal enriched withTamarindus indica (Tamarind) | Experimental | Not described Receives: Other: Indigenous Fruit and vegetable. |
| Reference meal one | Active comparator | Not described Receives: Other: Challenge meal that resembles the oral glucose tolerance test. |
| Reference meal two | Active comparator | Not described Receives: Other: Challenge meal that resembles the oral glucose tolerance test. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: From enrollment at each of the five postprandial visits, until the end of the postprandial study which will last five weeks
Secondary outcomes (7)
Incremental area under the curve blood triglyceride
Blood Triglyceride analysis for blood samples collected at 8 different time points:0, 15, 30, 60, 90, 120, 150 and 180 minutes
Measured: 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)
Blood HDL analysis for blood samples collected at 8 different time points:0, 15, 30, 60, 90, 120, 150 and 180 minutes
Measured: 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)
Blood LDL analysis for blood samples collected at 8 different time points:0, 15, 30, 60, 90, 120, 150 and 180 minutes
Measured: 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
Blood cholestrol analysis for blood samples collected at 8 different time points:0, 15, 30, 60, 90, 120, 150 and 180 minutes
Measured: 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
Plasma polyphenol metabolite analysis for blood samples collected at 8 different time points:0, 15, 30, 60, 90, 120, 150 and 180 minutes
Measured: 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 appetite visual analog scores
Appetite visual analog scores analysis at 8 different time points:0, 15, 30, 60, 90, 120, 150 and 180 minutes
Measured: 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
Palatability visual analog scores analysis at one time point:15 minutes
Measured: From enrollment at each of the five postprandial visits, until the end of the postprandial study which will last five weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2025
- Study start18 May 2026
- Primary completion17 Aug 2026
- Study completion17 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christophe Matthys, KU Leuven
- Investigators
- Christophe Matthys, Phd, Principal investigator, KU Leuven University, Belgium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07295600
- Sponsor's protocol ID
- Postprandial studies
- Status last verified
- Sep 2026
- First submitted
- 3 Dec 2025
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual Participant Data (IPD) Sharing Statement Plan to Share IPD: Plan Description: All the data generated during this study will comply with the prevailing standards and guidelines in documenting and depositing data sets. The results from this research will be disseminated in presentations at public lectures, scientific institutions and meetings, and/or publication in reputable journals. Data sharing will be performed in compliance with the International Committee of Medical Journal Editors. Individual de-identified participant data will be shared. In particular, individual participant data that underlie the results reported in our articles, after de-identification (text, tables, figures and appendices). Supporting Materials: Study Protocol Informed Consent Form (ICF) Analytic Code Time Frame: Data will become available from 9-36 months after the publication of the study results by the research team. Access Criteria: Data will only be shared with investigators
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07295600
- Acronym / sponsor ID
- Postprandial studies
- Conditions
- Type 2 Diabetes, Cardiometabolic Health
- Keywords
- Type 2 diabetes, Challenge meals, Postprandial, Glucose metabolism, Indigenous fruits and Vegetables
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- KU LeuvenUniversity, hospital or other
- Study start
- 18 May 2026 (actual)
- Primary completion
- 17 Aug 2026 (actual)
- Study completion
- 17 Aug 2026 (actual)
- First posted
- 19 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (13 listed)
- Taking dietary supplements
- Type 1 diabetes
- Tuberculosis co-infection
- Renal failure
- Liver cirrhosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Indigenous Fruit and vegetable.Indigenous fruit and vegetable freeze dried powder. | Other | 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.Isocaloric challenge meal | Other | Reference meal one, Reference meal two |
Primary outcome
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
7 secondary outcomes
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
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
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
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
- Individual participant dataSharing planned: Yes. Individual Participant Data (IPD) Sharing Statement Plan to Share IPD: Plan Description: All the data generated during this study will comply with the prevailing standards and guidelines in documenting and depositing data sets. The results from this research will be disseminated in presentations at public lectures, scientific institutions and meetings, and/or publication in reputable journals. Data sharing will be performed in compliance with the International Committee of Medical Journal Editors. Individual de-identified participant data will be shared. In particular, individual participant data that underlie the results reported in our articles, after de-identification (text, tables, figures and appendices). Supporting Materials: Study Protocol Informed Consent Form (ICF) Analytic Code Time Frame: Data will become available from 9-36 months after the publication of the study results by the research team. Access Criteria: Data will only be shared with investigators
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christophe Matthys, Phd principal investigator
KU Leuven University, Belgium
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Indigenous Fruit and vegetable. and Challenge meal that resembles the oral glucose tolerance test. in people with Type 2 Diabetes and Cardiometabolic Health, run by KU Leuven at 1 site in Uganda.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Uganda. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2026.