Effects of Cranberry on Gut and Metabolic Health
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 73
- 试验地点
- 1
- 主要终点
- Change in glucose homeostasis
研究概览
简要总结
The consumption of plant-based foods, particularly berries, has been associated with improved health due to their high content of bioactive compounds. Among these, polyphenols-especially proanthocyanidins (PACs)-may offer protective effects against chronic diseases related to overweight and obesity. Cranberries are naturally rich in PACs and may positively influence metabolic health by modulating the gut microbiota. However, their specific effects on intestinal integrity and broader metabolic outcomes remain underexplored.
The primary aim of this study is to assess the effects of cranberry supplementation on glucose metabolism, insulin sensitivity, blood lipid levels, and the composition and function of the gut microbiota in overweight and obese individuals.
This randomized, double-blind, placebo-controlled, crossover clinical trial will include two 12-week intervention periods-one with a cranberry beverage and one with a placebo-separated by a 4-week washout period and preceded by a 2-week lifestyle stabilization phase. Participants will undergo comprehensive metabolic assessments (glucose control, insulin sensitivity, lipid profile), body composition analysis, gut microbiota profiling, and liver fat imaging (MRI in a subsample of female participants). Additional evaluations will include markers of inflammation, appetite regulation, intestinal health, and lifestyle factors.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 25 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •body mass index between 25 and 40 kg/m2
- •at least one of the following criteria: fasting plasma insulin >60 pmol/L, fasting glycemia between 5.5 and 6.9 mmol/L, glycated hemoglobin (HbA1c) level of 5.7- 6.4% and/or fasting triglyceride >1.35 mmol/L.
排除标准
- •to have aversion to cranberry products
- •regularly drinking alcohol (>2 glasses/day)
- •having a significant change in body weight in the past 3 months (±5% of their body weight) due to bariatric surgery or other conditions
- •taking medication which may affect the study outcomes (i.e. antidiabetic and/or cholesterol or lipid-lowering medications and/or glucocorticosteroid in supraphysiological doses and/or anti-obesity medications)
- •taking regular probiotics and prebiotics (including fruit/berry polyphenol supplements) in the past 3 months
- •having eating disorders
- •had undergone major surgery 3 months prior to the study or if they had one planned
- •if they had intestinal malabsorption, cirrhosis or chronic kidney disease
- •being pregnant, planning a pregnancy, or breastfeeding.
研究组 & 干预措施
Cranberry beverage
干预措施: Cranberry beverage (Dietary Supplement)
Placebo beverage
干预措施: Placebo beverage (Dietary Supplement)
结局指标
主要结局
Change in glucose homeostasis
时间窗: Pre and post each treatment (12 week/each)
Assessment of glucose concentrations during a 3-hour oral glucose tolerance test (OGTT)
Change in insulin secretion
时间窗: Pre and post each treatment (12 week/each)
Assessment of insulin a concentrations during a 3-hour oral glucose tolerance test (OGTT)
Change in lipid profile
时间窗: Pre and post each treatment (12 week/each)
Assessment of triglycerides, LDL-cholesterol and HDL-cholesterol
次要结局
- Change in other measures of glucose homeostasis(Pre and post each treatment (12 week/each))
- Change in blood pressure(Pre and post each treatment (12 week/each))
- Change in chronic inflammation(Pre and post each treatment (12 week/each))
- Change in anthropometric measurements(Pre and post each treatment (12 week/each))
- Change in body composition(Pre and post each treatment (12 week/each))
- Change in gut microbiota(Pre and post each treatment (12 week/each))
- Change in gut microbiota function(Pre and post each treatment (12 week/each))
- Change in fat accumulation in the liver(Pre and post each treatment (12 week/each))