Impact of Free Sugar Replacement by Maple Syrup on Prevention of Metabolic Disorders Associated With Overweight in Humans : Role of Gut Microbiota
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 47
- 试验地点
- 2
- 主要终点
- Change in Glucose homeostasis
研究概览
简要总结
It has been suggested that the actual obesity epidemy is related to chronic overconsumption of added or free sugars. The increasing popularity of artificial sweeteners attest the population willingness to reduce added sugars intake and to use alternatives to alleviate health impact of free sugar overconsumption. However, recent findings suggest that artificial sweeteners may rather contribute to obesity epidemy and its associated adverse health effects, potentially via a negative impact on gut microbiota. It has been shown in various studies that, for the same amount of sucrose, unrefined sugars (such as maple syrup) are associated with favorable metabolic effects. The polyphenols contained in maple syrup, especially lignans, could contribute to these positive effects. Indeed, the strong impact of those biomolecules on the modulation of gut microbiota and on gastro-intestinal and metabolic health has been demonstrated in several studies. It is therefore highly relevant to test the hypothesis that the substitution of refined sugar by an equivalent amount of maple syrup (5% of daily energy intake) result in a lesser metabolic deterioration, by the modulation of maple syrup on gut microbiota, than the one observed with refined sugar.
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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •BMI between 23 and 40 kg/m2
- •At least one of the following: Fasting triglyceride > 1,35 mmol/L, Fasting insulinemia > 42 pmol/L, fasting glycemia between 5,5 and 6,9 mmol/L and glycated haemoglobin (HbA1c) between 5.7 and 6.4 %
- •Understanding of spoken and written french
- •Accept to follow study instructions
- •If there is natural health product consumption, the dose and frequency of consumption must be stable since 3 months or more
排除标准
- •Any metabolic disorder requiring medication or affecting glucose or lipid metabolism
- •Aversion for maple taste
- •Allergy or intolerance for maple syrup or for an ingredient of the placebo syrup
- •Alcohol consumption of > 2 drinks / day
- •Weight change > 5% of body weight in the last 3 months
- •Being in a weight loss attempt
- •Antibiotics intake in the last 3 months
- •Regular probiotics intake in the last 3 months
- •Major surgical operation in the last 3 months or planned in the next months
- •Gastrointestinal malabsorption
- •Cirrhosis
- •Chronic kidney disease
- •Pregnant or breastfeeding women or women planning pregnancy in the next months
- •Participation in another clinical trial
结局指标
主要结局
Change in Glucose homeostasis
时间窗: Change between the beginning and the end of each treatment (8 weeks each)
Evaluation of plasma glucose, insulin and c-peptide concentration using a 3-hour oral glucose tolerance test
次要结局
- Change in Lipid profile(Change between the beginning and the end of each treatment (8 weeks each))
- Change in Intestinal permeability(Change between the beginning and the end of each treatment (8 weeks each))
- Change in Short chain fatty acids in the feces(Change between the beginning and the end of each treatment (8 weeks each))
- Change in fat accumulation in the liver(Change between the beginning and the end of each treatment (8 weeks each))
- Change in Glucose homeostasis(Change between the beginning and the end of each treatment (8 weeks each))
- Change in Endotoxemia(Change between the beginning and the end of each treatment (8 weeks each))
- Change in Inflammation state of the tissue(Change between the beginning and the end of each treatment (8 weeks each))
- Change in Gut health and stool consistency(Change between the beginning and the end of each treatment (8 weeks each))
- Change in body composition(Change between the beginning and the end of each treatment (8 weeks each))
- Change in gene expression levels(Change between the beginning and the end of each treatment (8 weeks each))
- Change in chronic inflammation(Change between the beginning and the end of each treatment (8 weeks each))
- Change in maple-derived metabolites present in stool(Change between the beginning and the end of each treatment (8 weeks each))
- Change in Gut Microbiota Composition(Change between the beginning and the end of maple syrup treatment (8 weeks))
- Change in circulating levels of plasma metabolites(Change between the beginning and the end of each treatment (8 weeks each))
- Change in blood pressure(Change between the beginning and the end of each treatment (8 weeks each))
- Change in Gut Microbiota beta Diversity(Change between the beginning and the end of each treatment (8 weeks each))
- Change in anthropometric measurements(Change between the beginning and the end of each treatment (8 weeks each))
- Change in Gut Microbiota alpha Diversity(Change between the beginning and the end of each treatment (8 weeks each))