AzTrials
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ObesityNCT04551365

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

A study testing Lifestyle changes and Chitosan in people with Obesity and Lifestyle, run by University of Iceland at 1 site in Iceland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 80 years, women onlyHealthy volunteers can take part
Conditions the study is for
Obesity, Lifestyle
What is being tested?
Lifestyle changes and Chitosan
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
106 participants
Where
1 siteIceland
Study dates
15 Aug 2020to 15 Mar 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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)
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  • 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)

Who cannot join

  • 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
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  • 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

Trial locations and contacts

1 site in 1 country.

Iceland1 site

  • Reykjalundur, Rehabilitation Center

    Mosfellsbaer, 270

Other trials in Iceland

About this study

Official title: 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

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).

Read the detailed description

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
Obesity, Lifestyle
Being tested
Lifestyle changes, Chitosan, Placebo
Keywords
Gut Microbiota, Chitosan, Obesity, Body Composition, Body Weight, Health Status, Lifestyle, Defecation
Medical subject headings
Obesity, Body Weight

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Lifestyle changesBehavioural

    Also called Rehabilitation

    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

  • ChitosanDietary supplement

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

  • PlaceboOther

    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

Study groups in NCT04551365
Study groupRoleWhat they receive
Obese patients IExperimentalUndergoing lifestyle changes (rehabilitation) along daily intake of chitosan supplement, 4 capsules twice daily at main meals.
Receives: Behavioral: Lifestyle changes; Dietary Supplement: Chitosan
Obese patients IIPlacebo comparatorUndergoing lifestyle changes (rehabilitation) along daily intake of placebo, 4 capsules twice daily at main meals.
Receives: Behavioral: Lifestyle changes; Other: Placebo
Control IExperimentalDaily intake of chitosan supplement, 4 capsules twice daily at main meals.
Receives: Dietary Supplement: Chitosan
Control IIPlacebo comparatorDaily intake of placebo 4 capsules twice daily at main meals.
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Changes in the Composition of the Gut Microbiota

    Analysis of gut microbiota composition from stool samples

    Measured: Change from Baseline Gut Microbiota Composition at 2 weeks

  2. Changes in the Composition of the Gut Microbiota

    Analysis of gut microbiota composition from stool samples

    Measured: Change from Baseline Gut Microbiota Composition at 12 weeks

  3. Changes in the Composition of the Gut Microbiota

    Analysis of gut microbiota composition from stool samples

    Measured: Change from Baseline Gut Microbiota Composition at 14 weeks

  4. Changes in the Body Mass Index

    Body mass index calculated by dividing whole body weight by the squared height (kg/m2)

    Measured: Change from Baseline Body Mass Index at 2 weeks

  5. Changes in the Body Mass Index

    Body mass index calculated by dividing whole body weight by the squared height (kg/m2)

    Measured: Change from Baseline Body Mass Index at 12 weeks

  6. 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

    Measured: Change from Baseline Waist-to-Hip ratio at 12 weeks

  7. Changes in Total Body Fat Percentage

    Bioelectrical Impedance Analysis

    Measured: Change from Baseline Total Body Fat Percentage at 12 weeks

  8. Changes in Total Body Fat Percentage (Block 1, both arms)

    Dual-Energy X-Ray Absorptiometry (DXA)

    Measured: Change from Baseline Total Body Fat Percentage at 12 weeks

Secondary outcomes (13)

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

    Dual-Energy X-Ray Absorptiometry (DXA)

    Measured: Change from Baseline Abdominal Fat at 12 weeks

  2. Changes in Lean Body Mass

    Bioelectrical Impedance Analysis

    Measured: Change from Baseline Lean Body Mass at 12 weeks

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

    Dual-Energy X-Ray Absorptiometry (DXA)

    Measured: Change from Baseline Lean Body Mass at 12 weeks

  4. Changes in Long Term Blood Glucose Concentrations

    Measurement of glycated hemoglobin (B-HbAc1)

    Measured: Change from Baseline Long Term Blood Glucose Concentrations at 12 weeks

  5. Changes in Blood Glucose Concentrations

    Measurement of S-Glucose

    Measured: Change from Baseline Blood Glucose Concentrations at 2 weeks

  6. Changes in Blood Glucose Concentrations

    Measurement of S-Glucose

    Measured: Change from Baseline Blood Glucose Concentrations at 12 weeks

  7. Changes in Blood Lipide Profile

    Measurements of S-Cholesterol, S-High-density lipoprotein (HDL) cholesterol, S-Low-density lipoprotein (LDL) cholesterol and S-Triglycerides in blood

    Measured: Change from Baseline Blood Lipide Profile at 2 weeks

  8. Changes in Blood Lipide Profile

    Measurements of S-Cholesterol, S-High-density lipoprotein (HDL) cholesterol, S-Low-density lipoprotein (LDL) cholesterol and S-Triglycerides in blood

    Measured: Change from Baseline Blood Lipide Profile at 12 weeks

  9. Changes in Inflammation Marker

    Measurement of high-sensitivity C-reactive protein (hs-CRP) in blood

    Measured: Change from Baseline Inflammation Marker at 2 weeks

  10. Changes in Inflammation Marker

    Measurement of high-sensitivity C-reactive protein (hs-CRP) in blood

    Measured: Change from Baseline Inflammation Marker at 12 weeks

  11. Changes in Six Minute Walking Distance

    Walking distance measured with six minute walk test in 70 meters long corridor, as a measure of exercise endurance. The longer distance walked, the better exercise endurance.

    Measured: Change from Baseline Six Minute Walking Distance at 12 weeks

  12. Changes in Grip Strength

    Grip-strength measurements, three trials for each hand, mean value calculated

    Measured: Change from Baseline Grip Strength at 12 weeks

  13. Changes of Satiety Feeling (Block 1, both arms)

    Measurements of S-Leptin in blood

    Measured: Change from Baseline Satiety Feeling at 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Sep 2020
  2. Study start15 Aug 2020
  3. Primary completion30 Oct 2023
  4. Study completion15 Mar 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Two-block, each with 2 arms; a total of 4 arms
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
106 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04551365
Sponsor's protocol ID
UI-MicroFIBERgut
Status last verified
May 2024
First submitted
10 Jul 2020
Last updated
16 May 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: All individual participant data (non-personally identifiable) will be shared that underlie results in publication

Publications

  • Runarsdottir TR, Skirnisdottir S, Thors H, Harethardottir H, Corral-Jara KF, Klonowski AM, Halldorsson ThornI, Guethjonsdottir M. Effect of Chitosan Supplementation and Lifestyle Changes on Health and Gut Microbiota in Icelandic Females With Obesity. Mol Nutr Food Res. 2026 Aug;70(15):e70558. doi: 10.1002/mnfr.70558.

    PubMed 42522290

  • 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.

    PubMed 40484808

Questions about this trial

What is this clinical trial studying?

A study testing Lifestyle changes and Chitosan in people with Obesity and Lifestyle, run by University of Iceland at 1 site in Iceland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Iceland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in the Composition of the Gut Microbiota (time frame: Change from Baseline Gut Microbiota Composition at 2 weeks). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04551365, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2024.

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