Fecal Microbial Transplantation and Fiber Supplementation in Participants With Obesity and Metabolic Syndrome.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 68
- 试验地点
- 2
- 主要终点
- insulin sensitivity
研究概览
简要总结
Obesity is increasing in western society at a rapid rate and is associated with metabolic and cardiovascular disease. Although genetics, improper diet, and sedentary lifestyle are known to be factors that can cause obesity, there is a new idea that certain gut microbes may also be involved. Patients who are obese tend to have different kinds of gut microbes compared with lean healthy individuals. Previous studies have shown that changing the gut microbes of obese individuals by doing a fecal transplant (FMT) using gut microbes from a lean individual improves insulin resistance. However, the effects were not maintained. In addition, research has highlighted a necessary role for dietary fiber in the maintenance of microbes required for human health and also that increasing dietary fiber can reduce inflammation that is associated with insulin resistance. This project builds on the findings that gut microbes can be modulated by both FMT and dietary fiber supplementation and will examine if combining these two treatments can increase the effectiveness of these treatments.
The objective of this study is to use fecal microbial transplant to change the gut microbes of obese individuals to those seen in lean individuals and then to use fiber supplements to help maintain the beneficial effects. In this study, overweight individuals who have metabolic syndrome will receive a fecal transplant using a pill form and then consume a variety of fiber supplements for 6 weeks. Effects on metabolic parameters, quality of life, weight, and dietary intake will be followed. Microbial composition will be measured in stool samples.
详细描述
Phase: This is a phase II clinical trial.
Methodology: This is an exploratory, four-arm, parallel design, randomized placebo-controlled intervention study.
Study Duration: 12 weeks Study Center(s): This is a single center trial at the University of Alberta
Objectives:The objective of this study is to determine if fecal microbial transplantation (FMT) combined with supplementation with a combined fiber supplement of resistant starch type 4, acacia gum, and soluble corn fiber has a clinically significant effect on metabolic outcomes in obese subjects with metabolic syndrome
Primary Outcome: Changes in insulin sensitivity between the time of screening and 6 weeks following treatment.
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
- Triple (Participant, Care Provider, 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
- •• Age ≥ 18 and < 65 years at the time of screening
- •BMI > 30
- •Total body weight fluctuation over the last 6 months less than 10%
- •Fasting plasma glucose (FPG): 1) > 5.6 mmol/L OR Hemoglobin A1c ≥6.5% (with or without taking an oral antidiabetic medication).
- •At least one of the following criterion:
- •Fasting triglyceride ≥1.7 (TG) mmol/L (with or without taking a statin or fibrate)
- •HDL cholesterol <1.03 mmol/L in males or <1.29 mmol/L in females (with or without taking a statin or fibrate)
- •Established diagnosis of hypertension OR SBP ≥130 or DBP ≥85 mmHg (with or without taking at least one antihypertensive agent).
排除标准
- •• Systolic blood pressure ≥180 or diastolic blood pressure ≥110 mmHg at screening.
- •Triglyceride ≥6 mmol/L.
- •Acute infectious or inflammatory condition over the presiding 4 weeks.
- •Current or recent use (Previous 6 months) of insulin for diabetes control.
- •History of oropharyngeal or significant esophageal dysphagia, inflammatory bowel disease, colon cancer, or colonic polyps with high grade dysplasia.
- •History of autoimmune conditions or chronic inflammatory condition, such as rheumatoid arthritis, chronic active hepatitis B or C, HIV, chronic pancreatitis, advanced NASH, or liver cirrhosis.
- •Active malignancy.
- •Active substance abuse or excessive EtOH (defined as >2 X 8oz drinks/d).
结局指标
主要结局
insulin sensitivity
时间窗: Change between the time of screening and 6 weeks following treatment.
The primary endpoint is the change in insulin sensitivity between the time of screening and 6 weeks following treatment.
次要结局
- fasting glucose(Changes between baseline and 6 and 12 weeks)
- Waist to hip circumferences(Changes between baseline and 6 and 12 weeks)
- HbA1C(Changes between baseline and 6 and 12 weeks)
- BMI(Changes between baseline and 6 and 12 weeks)
- oral glucose tolerance(Changes between baseline and 6 and 12 weeks)
- fecal microbiota composition(Changes between baseline and 6 and 12 weeks)
- blood pressure(Changes between baseline and 6 and 12 weeks)
- EuroQol five dimensions questionnaire (EQ-5D™)(Changes between baseline and 6 and 12 weeks)
- SLIM Hunger and Satiety Questionnaire(Changes between baseline and 6 and 12 weeks)
- stool short chain fatty acid composition(Changes between baseline and 6 and 12 weeks)
- Fasting lipid profile(Changes between baseline and 6 and 12 weeks)
- serum levels of leptin, adiponectin, ghrelin, CRP, TNF-α, IL-6, LPS, and LPS-binding protein(Changes between baseline and 6 and 12 weeks)
研究者
Karen Madsen
Director, CEGIIR Professor, Division of Gastroenterology
University of Alberta