Effects of Lifestyle Changes and Chitosan on Gut Microbiota Modulation, Body Weight and Important Health Markers in Selected Population Groups: A Double-blind, Block-randomized, Placebo-controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 106
- 试验地点
- 2
- 主要终点
- Changes in the Body Mass Index
研究概览
简要总结
The purpose of this study is to compare the effects of chitosan diet supplementation to a placebo supplement on changes in gut microbiota, body weight and different health parameters among different population groups, being either obese (BMI 30-50) and undertaking major changes in lifestyle (patients) or being those not undergoing any major lifestyle changes (volunteers, BMI 18.5-35).
详细描述
The study will be conducted as a double-blind, block randomized, placebo-controlled intervention trial to study the effects of chitosan supplementation among two women population groups (Block 1- patients with obesity undergoing lifestyle changes; Block 2-women not undergoing major lifestyle changes) on their gut microbiota composition, body weight and composition among several other health parameters (blood pressure, blood lipids, blood sugar, insulin, hs-CRP, leptin). Furthermore, additional information will be collected: Health status, mental health, physical activity level, evaluation of stool appearance and defecation frequency by means of questionnaires; physical activity tracking, changes in body composition (muscle mass, body and visceral fat); evaluation of physical performance as well as adverse effects and remarks (diary book). The overall trial time for each subject will be 15 weeks: 1 week for baseline evaluation, 12 weeks intervention period and 2 weeks follow up.Collection of data will be done at 4 timepoints: at baseline, after 2 weeks of treatment, after 12 weeks of treatment and 2 weeks after the treatment ends (follow up).
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women, 18-80 years old with BMI >30 kg/m2, maximal supine width 65 cm.
- •Living in the proximity (about 60 km radius) of Reykjavik
- •Ready to stop any intake of probiotics (i.e. Bio-Kult) and weight control supplement during the trial period (3.5 months)
- •Undertaking major lifestyle changes (diet and physical exercise)
- •Not planning pregnancy during the treatment period (3 months)
- •Women, 18-80 years old with BMI 18.5-35 kg/m2
- •Living in the proximity (about 60 km radius) of Reykjavik
- •Ready to stop any intake of probiotics (i.e. Bio-Kult) and weight control supplement during the trial period (3.5 months)
- •Not undertaking any major changes in lifestyle
- •Not planning pregnancy during the treatment period (3 months)
排除标准
- •Eating disorders (i.e. anorexia, bulimia)
- •Inflammatory bowel disease (e.g. Crohn's disease, ulcerative colitis)
- •History of poorly controlled diabetes mellitus or hypertension
- •Surgical procedures (abdominal and chest) or bariatric operation in the past 6 months
- •History of invasive fat reduction procedure (e.g. liposuction or abdominoplasty) within the past one year
- •Drug use: a) Drugs that can cause weight loss: SGLT2 inhibitors or GLP-1 analogs or other drugs simulating incretins in the digestive system for less than 3 months b) Warfarin
- •Shellfish allergy
- •Pregnant or breastfeeding
- •Subjects taking or having taken diet pills or weight management supplements in past 30 days
- •Use of antibiotics in the last 3 months
结局指标
主要结局
Changes in the Body Mass Index
时间窗: Change from Baseline Body Mass Index at 12 weeks
Body mass index calculated by dividing whole body weight by the squared height (kg/m2)
Changes in Total Body Fat Percentage
时间窗: Change from Baseline Total Body Fat Percentage at 12 weeks
Bioelectrical Impedance Analysis
Changes in the Waist-to-Hip ratio
时间窗: Change from Baseline Waist-to-Hip ratio at 12 weeks
Waist circumference is measured as midpoint between the lower margin of the last palpable rib and the top of the iliac crest. Hip circumference is measured around the widest portion of the buttocks. Waist-to-hip ratio calculated by dividing waist circumference measurement by the hip circumference measurement
Changes in Total Body Fat Percentage (Block 1, both arms)
时间窗: Change from Baseline Total Body Fat Percentage at 12 weeks
Dual-Energy X-Ray Absorptiometry (DXA)
Changes in the Composition of the Gut Microbiota
时间窗: Change from Baseline Gut Microbiota Composition at 14 weeks
Analysis of gut microbiota composition from stool samples
次要结局
- Changes in Abdominal Fat (Block 1, both arms)(Change from Baseline Abdominal Fat at 12 weeks)
- Changes in Lean Body Mass (Block 1, both arms)(Change from Baseline Lean Body Mass at 12 weeks)
- Changes in Lean Body Mass(Change from Baseline Lean Body Mass at 12 weeks)
- Changes in Long Term Blood Glucose Concentrations(Change from Baseline Long Term Blood Glucose Concentrations at 12 weeks)
- Changes in Blood Lipide Profile(Change from Baseline Blood Lipide Profile at 12 weeks)
- Changes in Six Minute Walking Distance(Change from Baseline Six Minute Walking Distance at 12 weeks)
- Changes in Blood Glucose Concentrations(Change from Baseline Blood Glucose Concentrations at 12 weeks)
- Changes in Inflammation Marker(Change from Baseline Inflammation Marker at 12 weeks)
- Changes in Grip Strength(Change from Baseline Grip Strength at 12 weeks)
- Changes of Satiety Feeling (Block 1, both arms)(Change from Baseline Satiety Feeling at 12 weeks)
研究者
Marta Guðjónsdóttir
Assistant professor
University of Iceland