Micro-nutritional Status and Gut Microbiota in Morbidly Obese Patients Before and After Gastric Bypass With and Without Micro-nutritional Supplementation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Glutathione peroxidise
研究概览
简要总结
An intervention study design in 90 obese patients will be used. Nutritional, metabolic and psychological status as well as gut microbiota will be evaluated before gastric bypass and 6 months post surgery. During this period of 6 months, all patients will receive a specific diet according to recommendation with regard to bariatric surgery.
Subjects will be than randomized in 2 sub-groups:
A. patients receiving a standard healthy diet without micro-nutriments' supplementation; B. patients receiving a healthy diet and probiotics, minerals, aminoacids, omega-3 acids vitamin and mineral supplementation
详细描述
The primary aim of the study is to analyse the micro-nutritional status in morbidly obese patients before and 6 months after bariatric surgery (Roux-en-Y gastric bypass, RYGB). The secondary outcome will be the impact of 6 months probiotics, minerals, aminoacids, omega-3 acids and vitamin supplementation on microbiota, metabolic and psychological parameters 12 months post-RYGB.
An intervention study in 90 obese patients (BMI>40 kg/m2) will be used. Nutritional, metabolic and psychological status as well as gut microbiota will be evaluated before gastric bypass and 6 months post RYGB. During this period of 6 months, all patients will receive a specific diet according to recommendation with regard to RYGB.
Subjects will be than randomized in 2 sub-groups:
A. patients receiving a standard healthy diet without micro-nutriments' supplementation; B. patients receiving a healthy diet and probiotics, minerals, aminoacids, omega-3 acids vitamin and mineral supplementation Healthy diet will be defined as follow: 9-15% of proteins, 50-55% of carbohydrates and 30-35% lipids (25% saturated fat, 50% mono-unsaturated fat and 25% poly-unsaturated fat).
The following parameters will be analysed before RYGB and 6 months and 12 months post RYGB, respectively:
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
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Obesity BMI>40 kg/m2
排除标准
- •Antidepressant treatment
研究组 & 干预措施
Standard diet
Standard healthy diet after RYGB surgery
干预措施: Bariatric surgery (Procedure)
Micro-nutriments' supplementation
Healthy diet and probiotics, minerals, aminoacids, omega-3 acids vitamin and mineral supplementation after RYGB surgery
干预措施: Diet supplementation (Drug)
Micro-nutriments' supplementation
Healthy diet and probiotics, minerals, aminoacids, omega-3 acids vitamin and mineral supplementation after RYGB surgery
干预措施: Bariatric surgery (Procedure)
结局指标
主要结局
Glutathione peroxidise
时间窗: Change from Baseline at 6-months and 12-months post-RYGB
Vitamins A levels
时间窗: Change from Baseline at 6-months and 12-months post-RYGB
Vitamin E levels
时间窗: Change from Baseline at 6-months and 12-months post-RYGB
Selenium levels
时间窗: Change from Baseline at 6-months and 12-months post-RYGB
Zinc levels
时间窗: Change from Baseline at 6-months and 12-months post-RYGB
Superoxide dismutase
时间窗: Change from Baseline at 6-months and 12-months post-RYGB
Iron levels
时间窗: Change from Baseline at 6-months and 12-months post-RYGB
Copper levels
时间窗: Change from Baseline at 6-months and 12-months post-RYGB
次要结局
- LDL-cholesterol(6-months and 12-months post-RYGB)
- Triglycerides(6-months and 12-months post-RYGB)
- Fasting glucose(6-months and 12-months post-RYGB)
- C-Reactive Protein(6-months and 12-months post-RYGB)
- Linoleic acid(6-months and 12-months post-RYGB)
- Eicosapentaenoic acid (EPA)(6-months and 12-months post-RYGB)
- Docosahexaenoic acid (DHA)(6-months and 12-months post-RYGB)
- Gut microbiota modifications (sequencing the V4 region of 16S rDNA)(6-months and 12-months post-RYGB)
- Anxiety (questionnaire HAD)(6-months and 12-months post-RYGB)
- Depression (questionnaire HAD)(6-months and 12-months post-RYGB)
- Total cholesterol(6-months and 12-months post-RYGB)
- HDL-cholesterol(6-months and 12-months post-RYGB)
- Fasting insulin(6-months and 12-months post-RYGB)
- Alpha-linoleic acid (ALA)(6-months and 12-months post-RYGB)
- Quality of life (questionnaire IWQOL)(6-months and 12-months post-RYGB)
研究者
Zoltan Pataky
Deputy Head
University Hospital, Geneva