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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

106 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-15

Study Completion Date

2024-03-15

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).

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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).

Conditions

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Obesity Lifestyle

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Two-block, each with 2 arms; a total of 4 arms

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Obese patients I

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

Group Type EXPERIMENTAL

Lifestyle changes

Intervention Type BEHAVIORAL

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

Chitosan

Intervention Type DIETARY_SUPPLEMENT

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

Obese patients II

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

Group Type PLACEBO_COMPARATOR

Lifestyle changes

Intervention Type BEHAVIORAL

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

Placebo

Intervention Type OTHER

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

Control I

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

Group Type EXPERIMENTAL

Chitosan

Intervention Type DIETARY_SUPPLEMENT

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

Control II

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

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

Interventions

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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

Intervention Type BEHAVIORAL

Chitosan

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

Intervention Type DIETARY_SUPPLEMENT

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

Intervention Type OTHER

Other Intervention Names

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Rehabilitation

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes