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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- KU Leuven
- 入组人数
- 13
- 试验地点
- 2
- 主要终点
- Incremental area under the curve blood glucose
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 30 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Challenge meal enriched with Hibiscus sabdariffa (Hibiscus)
干预措施: Indigenous Fruit and vegetable. (Other)
Challenge meal enriched with Solunum anguivi (Forest bitter berries)
干预措施: Indigenous Fruit and vegetable. (Other)
Challenge meal enriched withTamarindus indica (Tamarind)
干预措施: Indigenous Fruit and vegetable. (Other)
Reference meal one
干预措施: Challenge meal that resembles the oral glucose tolerance test. (Other)
Reference meal two
干预措施: Challenge meal that resembles the oral glucose tolerance test. (Other)
结局指标
主要结局
Incremental area under the curve blood glucose
时间窗: 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
次要结局
- Incremental area under the curve appetite visual analog scores(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 blood triglyceride(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(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)(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(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)(From enrollment at each of the five postprandial visits, until the end of the postprandial study which will last five weeks)