MicroFIBERgut: Effects of Lifestyle Changes and Chitosan on Gut Microbiota and Weight Management

Study Overview
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Brief Summary
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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).

Detailed Description
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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).

Official Title
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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

Conditions
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Obesity, Lifestyle

Intervention / Treatment
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* Behavioral: Lifestyle changes
* Dietary Supplement: Chitosan
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Block 1 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) Block 2 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) Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Two-block, each with 2 arms; a total of 4 arms
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Obese patients I<br>Undergoing lifestyle changes (rehabilitation) along daily intake of chitosan supplement, 4 capsules twice daily at main meals. | Behavioral: Lifestyle changes<br>* Interdisciplinary rehabilitation programmes 5 days per week, for 4-6 weeks. The aim of the rehabilitation programme is to improve lifestyle through improved planning of activities of daily life, improved planning of food intake, increased physical activity, and weight loss. The focus is on physical and mental well-being and reinforcing participation in social activities. Patients are encouraged to carry on with their lifestyle changes after dismission from the program. Total duration 14 weeks<br>* Other names: Rehabilitation;Dietary Supplement: Chitosan<br>* Daily intake of chitosan supplement. Daily dose: 4 capsules(1,5 g chitosan) twice at main meals; total 3 g Duration: 12 weeks<br>|
| Placebo Comparator: Obese patients II<br>Undergoing lifestyle changes (rehabilitation) along daily intake of placebo, 4 capsules twice daily at main meals. | Behavioral: Lifestyle changes<br>* Interdisciplinary rehabilitation programmes 5 days per week, for 4-6 weeks. The aim of the rehabilitation programme is to improve lifestyle through improved planning of activities of daily life, improved planning of food intake, increased physical activity, and weight loss. The focus is on physical and mental well-being and reinforcing participation in social activities. Patients are encouraged to carry on with their lifestyle changes after dismission from the program. Total duration 14 weeks<br>* Other names: Rehabilitation;Other: Placebo<br>* Daily intake of placebo (Microcrystalline cellulose (MCC), and native maize food starch (FS)) Daily dose: 4 capsules(0.75 g MCC + 0.75 g FS) twice at main meals; total 3 g Duration: 12 weeks<br>|
| Experimental: Control I<br>Daily intake of chitosan supplement, 4 capsules twice daily at main meals. | Dietary Supplement: Chitosan<br>* Daily intake of chitosan supplement. Daily dose: 4 capsules(1,5 g chitosan) twice at main meals; total 3 g Duration: 12 weeks<br>|
| Placebo Comparator: Control II<br>Daily intake of placebo 4 capsules twice daily at main meals. | Other: Placebo<br>* Daily intake of placebo (Microcrystalline cellulose (MCC), and native maize food starch (FS)) Daily dose: 4 capsules(0.75 g MCC + 0.75 g FS) twice at main meals; total 3 g Duration: 12 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in the Composition of the Gut Microbiota | Analysis of gut microbiota composition from stool samples | Change from Baseline Gut Microbiota Composition at 2 weeks | 
| Changes in the Composition of the Gut Microbiota | Analysis of gut microbiota composition from stool samples | Change from Baseline Gut Microbiota Composition at 12 weeks | 
| Changes in the Composition of the Gut Microbiota | Analysis of gut microbiota composition from stool samples | Change from Baseline Gut Microbiota Composition at 14 weeks | 
| Changes in the Body Mass Index | Body mass index calculated by dividing whole body weight by the squared height (kg/m2) | Change from Baseline Body Mass Index at 2 weeks | 
| Changes in the Body Mass Index | Body mass index calculated by dividing whole body weight by the squared height (kg/m2) | Change from Baseline Body Mass Index at 12 weeks | 
| Changes in the Waist-to-Hip ratio | 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 | Change from Baseline Waist-to-Hip ratio at 12 weeks | 
| Changes in Total Body Fat Percentage | Bioelectrical Impedance Analysis | Change from Baseline Total Body Fat Percentage at 12 weeks | 
| Changes in Total Body Fat Percentage (Block 1, both arms) | Dual-Energy X-Ray Absorptiometry (DXA) | Change from Baseline Total Body Fat Percentage at 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Abdominal Fat (Block 1, both arms) | Dual-Energy X-Ray Absorptiometry (DXA) | Change from Baseline Abdominal Fat at 12 weeks | 
| Changes in Lean Body Mass | Bioelectrical Impedance Analysis | Change from Baseline Lean Body Mass at 12 weeks | 
| Changes in Lean Body Mass (Block 1, both arms) | Dual-Energy X-Ray Absorptiometry (DXA) | Change from Baseline Lean Body Mass at 12 weeks | 
| Changes in Long Term Blood Glucose Concentrations | Measurement of glycated hemoglobin (B-HbAc1) | Change from Baseline Long Term Blood Glucose Concentrations at 12 weeks | 
| Changes in Blood Glucose Concentrations | Measurement of S-Glucose | Change from Baseline Blood Glucose Concentrations at 2 weeks | 
| Changes in Blood Glucose Concentrations | Measurement of S-Glucose | Change from Baseline Blood Glucose Concentrations at 12 weeks | 
| Changes in Blood Lipide Profile | Measurements of S-Cholesterol, S-High-density lipoprotein (HDL) cholesterol, S-Low-density lipoprotein (LDL) cholesterol and S-Triglycerides in blood | Change from Baseline Blood Lipide Profile at 2 weeks | 
| Changes in Blood Lipide Profile | Measurements of S-Cholesterol, S-High-density lipoprotein (HDL) cholesterol, S-Low-density lipoprotein (LDL) cholesterol and S-Triglycerides in blood | Change from Baseline Blood Lipide Profile at 12 weeks | 
| Changes in Inflammation Marker | Measurement of high-sensitivity C-reactive protein (hs-CRP) in blood | Change from Baseline Inflammation Marker at 2 weeks | 
| Changes in Inflammation Marker | Measurement of high-sensitivity C-reactive protein (hs-CRP) in blood | Change from Baseline Inflammation Marker at 12 weeks | 
| Changes in Six Minute Walking Distance | Walking distance measured with six minute walk test in 70 meters long corridor, as a measure of exercise endurance. The longer distance walked, the better exercise endurance. | Change from Baseline Six Minute Walking Distance at 12 weeks | 
| Changes in Grip Strength | Grip-strength measurements, three trials for each hand, mean value calculated | Change from Baseline Grip Strength at 12 weeks | 
| Changes of Satiety Feeling (Block 1, both arms) | Measurements of S-Leptin in blood | Change from Baseline Satiety Feeling at 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gut Microbiota, Chitosan, Obesity, Body Composition, Body Weight, Health Status, Lifestyle, Defecation