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

NCT04551365 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 106

Last updated 2024-05-16

No results posted yet for this study

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

Interventions

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

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

Sponsors & Collaborators

  • Matís ohf

    collaborator UNKNOWN

  • Reykjalundur Rehabilitation Center

    collaborator UNKNOWN

  • Primex ehf

    collaborator INDUSTRY

  • University of Iceland

    lead OTHER

Principal Investigators

  • Sigurlaug Skirnisdottir, Ph.D. · Matís ohf

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-08-15
Primary Completion
2023-10-30
Completion
2024-03-15

Countries

  • Iceland

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04551365 on ClinicalTrials.gov