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

NCT04551365 | Completed

• 1 other identifier: UI-MicroFIBERgut
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Obesity; Lifestyle

Keywords

Gut Microbiota; Chitosan; Obesity; Body Composition; Body Weight; Health Status; Lifestyle; Defecation

Outcome Measures

Primary Outcomes (8)

• 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 Outcomes (13)

• Changes in Abdominal Fat (Block 1, both arms)

  Change from Baseline Abdominal Fat at 12 weeks

• Changes in Lean Body Mass

  Change from Baseline Lean Body Mass at 12 weeks

• Changes in Lean Body Mass (Block 1, both arms)

  Change from Baseline Lean Body Mass at 12 weeks

• Changes in Long Term Blood Glucose Concentrations

  Change from Baseline Long Term Blood Glucose Concentrations at 12 weeks

• Changes in Blood Glucose Concentrations

  Change from Baseline Blood Glucose Concentrations at 2 weeks

Other Outcomes (9)

• Changes of Health Status

  Change from Baseline Health Status at 12 weeks

• Changes of Depression Severity

  Changes from Baseline Depression Severity at 12 weeks

• Changes of General Anxiety Symptoms

  Changes from Baseline General Anxiety Symptoms and at 12 weeks

Study Arms (4)

Obese patients I

EXPERIMENTAL

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

Behavioral: Lifestyle changes; Dietary Supplement: Chitosan

Obese patients II

PLACEBO COMPARATOR

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

Behavioral: Lifestyle changes; Other: Placebo

Control I

EXPERIMENTAL

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

Dietary Supplement: Chitosan

Control II

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

Lifestyle changes 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

Also known as: Rehabilitation

Obese patients I; Obese patients II

Chitosan 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 I; Obese patients I

Placebo 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 II; Obese patients II

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Iceland: lead
• Matís ohf: collaborator
• Reykjalundur Rehabilitation Center: collaborator
• Primex ehf: collaborator

Study Sites (1)

Reykjalundur, Rehabilitation Center

Mosfellsbaer, 270, Iceland

Location

Related Publications (1)

• Runarsdottir TR, Skirnisdottir S, Thors H, Harethardottir H, Corral-Jara KF, Klonowski AM, Halldorsson ThornI, Marteinsson VThorn, Guethjonsdottir M. The Effect of Chitosan Supplementation on the Gut Microbiota and Various Health Factors in Icelandic Females: A Placebo-Controlled, Double-Blind, Randomized Trial. Mol Nutr Food Res. 2025 Oct;69(19):e70137. doi: 10.1002/mnfr.70137. Epub 2025 Jun 8.

  PMID: 40484808 DERIVED

MeSH Terms

Conditions

Obesity; Body Weight

Interventions

Rehabilitation; Chitosan

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services; Chitin; Biopolymers; Polymers; Macromolecular Substances; Polysaccharides; Carbohydrates

Study Officials

• Sigurlaug Skirnisdottir, Ph.D.

  Matís ohf

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

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

Study Record Dates

• First Submitted: July 10, 2020
• First Posted: September 16, 2020
• Study Start: August 15, 2020
• Primary Completion: October 30, 2023
• Study Completion: March 15, 2024
• Last Updated: May 16, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Generally, data will be made available six months after the publication of each study.
• Access Criteria: Data sharing request will be handled by the corresponding author of each publication.

Locations

IC (1)