Kajjansi Health Centre IV
Wakiso, Uganda
Location status: Recruiting
NCT Number: NCT07295600
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.
Interested in participating?
Request Info30 year–60 year
All sexes
Interventional
Not applicable
Wakiso, Uganda
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Indigenous fruit and vegetable freeze dried powder.
Isocaloric challenge meal
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
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
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
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
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
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
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
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
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
Time frame: Fat mass will be calculated only on day one of the study that lasts five weeks
Bioelectrical impedence analysis will be performed
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
Contact information is provided by the study sponsor or research team.
Fred Kigozi, MSc
CONTACT
Tonny Kiyimba, PhD
CONTACT
KU Leuven
Other
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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