Title

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
  • Phase

    N/A
  • Study Type

    Interventional
  • Status

    Recruiting
  • Intervention/Treatment

    Chitosan ...
  • Study Participants

    148
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).
Study Started
Aug 15
2020
Primary Completion
Dec 30
2022
Anticipated
Study Completion
Aug 01
2023
Anticipated
Last Update
Dec 02
2021

Behavioral Lifestyle changes

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

  • Other names: Rehabilitation

Dietary Supplement Chitosan

Daily intake of chitosan supplement. Daily dose: 4 capsules(1,5 g chitosan) twice at main meals; total 3 g Duration: 12 weeks

Other Placebo

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

Obese patients I Experimental

Undergoing lifestyle changes (rehabilitation) along daily intake of chitosan supplement, 4 capsules twice daily at main meals.

Obese patients II Placebo Comparator

Undergoing lifestyle changes (rehabilitation) along daily intake of placebo, 4 capsules twice daily at main meals.

Control I Experimental

Daily intake of chitosan supplement, 4 capsules twice daily at main meals.

Control II Placebo Comparator

Daily intake of placebo 4 capsules twice daily at main meals.

Criteria

Inclusion Criteria:

Block 1

Women, 18-80 years old with BMI 30-50 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)
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: Orlistat, liraglutide, Glucagon-like peptide-1 (GLP 1) analogs and SGLT2 inhibitors 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
No Results Posted