Effects of Oral Glutamine Supplementation on Insulin Resistance and Functional Intestinal Disorders in Obese Patients.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Change between Homeostasic model assessment of insulin resistance test value at baseline and week 8
研究概览
简要总结
Obesity, which has a prevalence at 15% in France, is a major public health concern. Altered glycemic control and irritable bowel syndrome (IBS) are frequently observed in obese patients and lead to reduce the quality of life. In the last decades, the role of gut microbiota and intestinal permeability has been underlined in obesity, glycemic control and IBS. Interestingly, experimental and clinical data show that glutamine, an amino acid, is able to maintain or restore intestinal permeability in different conditions. We thus hypothesize that oral glutamine supplementation may restore gut barrier function contributing to improve glycemic control and IBS-symptoms. Our project will thus aim to evaluate the effects of 8 weeks - oral glutamine supplementation on glycemic control and IBS symptoms in obese patients in a blinded randomized controlled trial. Placebo group will received protein powder. 55 obese patients will enrolled in each arm and will received oral glutamine supplementation or protein powder (10g t.i.d.) during 8 weeks. Blood and feces samples and intestinal permeability assays will be performed at baseline (w0), after 8 weeks of supplementation (w8) and then after 8 weeks of a wash-out period (w16).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged from 18 to 65 years
- •Patient with h grade II or III obesity (body mass index equal or higher than 35 kg/m2)
- •Patient with insulino-resistance (fasting glycaemia ≥ 1g/l et < 1.26 g/l)
- •Patient with irritable bowel syndrome (Rome IV criteria ≥ 2)
排除标准
- •Patient with Known liver insufficiency (prothrombin time < 70%)
- •Patient with Known kidney failure (GFR < 60 ml/mn)
- •Patient with Known intestinal diseases such as inflammatory bowel diseases
- •Vomiting patients (≥ 1/ day) during the last 4 weeks
- •Patient Previously received bariatric surgery or digestive surgery
- •Patient Using laxatives or protein powder during the 4 last weeks
- •On going Pregnancy
研究组 & 干预措施
Oral glutamine supplementation
patient will receive Oral glutamine supplementation 10 g Ter In Die during 8 weeks
干预措施: Insulin-resistance evaluation (Procedure)
Oral glutamine supplementation
patient will receive Oral glutamine supplementation 10 g Ter In Die during 8 weeks
干预措施: Oral glutamine supplementation (Dietary Supplement)
Oral glutamine supplementation
patient will receive Oral glutamine supplementation 10 g Ter In Die during 8 weeks
干预措施: Functional intestinal disorders evaluation (Procedure)
Oral protein powder supplementation
patient will receive Oral protein powder supplementation10 g Ter In Die during 8 weeks
干预措施: Oral protein powder supplementation (Dietary Supplement)
Oral protein powder supplementation
patient will receive Oral protein powder supplementation10 g Ter In Die during 8 weeks
干预措施: Insulin-resistance evaluation (Procedure)
Oral protein powder supplementation
patient will receive Oral protein powder supplementation10 g Ter In Die during 8 weeks
干预措施: Functional intestinal disorders evaluation (Procedure)
结局指标
主要结局
Change between Homeostasic model assessment of insulin resistance test value at baseline and week 8
时间窗: Week 8
次要结局
- Change between Homeostasic model assessment of insulin resistance test value at baseline and week 16(Week 16)
- Change between Homeostasic model assessment of insulin resistance test value at Week 8 and week 16(week 16)
- Change between Irritable Bowel Syndrome (IBS) severity score at baseline and week 8(Week 8)
- Change between Irritable Bowel Syndrome (IBS) severity score at baseline and week 16(Week 16)
- Change between feces consistency at baseline and week 16(Week 16)
- Change between feces consistency at baseline and week 8(Week 8)