microfibergut: effects of lifestyle changes and chitosan on gut microbiota and weight management

Conditions: Obesity; Lifestyle

Summary: 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).

Eligibility criteria:
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

Keywords: gut microbiota chitosan obesity body composition body weight health status lifestyle defecation