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

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

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).

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).

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