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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Challenge meal enriched with Hibiscus sabdariffa (Hibiscus) | Experimental |
| |
| Challenge meal enriched with Solunum anguivi (Forest bitter berries) | Experimental |
| |
| Challenge meal enriched withTamarindus indica (Tamarind) | Experimental |
| |
| Reference meal one | Active Comparator |
| |
| Reference meal two | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Indigenous Fruit and vegetable. | Other | Indigenous fruit and vegetable freeze dried powder. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Body mass Index (BMI) | BMI will be calculated using height and weight | BMI will be calculated only on day one of the study that lasts five weeks |
| Fat mass | Bioelectrical impedence analysis will be performed |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tonny Kiyimba, PhD | Contact | +256706923575 | tonny.kiyimba1@gmail.com | |
| Fred Kigozi, MSc | Contact | +256701530822 | fred.kigozi49@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Christophe Matthys, Phd | KU Leuven University, Belgium | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kajjansi Health Centre IV | Recruiting | Wakiso | Uganda |
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
9 to 18 months after article publication.
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| Challenge meal that resembles the oral glucose tolerance test. | Other | Isocaloric challenge meal |
|
Blood HDL 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 |
| 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 | 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 | 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 | 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 | 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 | From enrollment at each of the five postprandial visits, until the end of the postprandial study which will last five weeks |
| Fat mass will be calculated only on day one of the study that lasts five weeks |
| Waist circumference | Wait circumference will be measured using a measuring tape | Waist circumference will be calculated only on day one of the study that lasts five weeks |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D014675 | Vegetables |
| ID | Term |
|---|---|
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
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