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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04551365
Recruitment Status : Recruiting
First Posted : September 16, 2020
Last Update Posted : September 16, 2020
Sponsor:
Collaborators:
Matís ohf
Reykjalundur Rehabilitation Center
Primex ehf
Information provided by (Responsible Party):
Marta Guðjónsdóttir, University of Iceland

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).

Condition or disease Intervention/treatment Phase
Obesity Lifestyle Behavioral: Lifestyle changes Dietary Supplement: Chitosan Other: Placebo Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 148 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Two-block, each with 2 arms; a total of 4 arms
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : August 15, 2020
Estimated Primary Completion Date : June 30, 2022
Estimated Study Completion Date : February 1, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Obese patients I
Undergoing lifestyle changes (rehabilitation) along daily intake of chitosan supplement, 4 capsules twice daily at main meals.
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 Name: 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

Placebo Comparator: Obese patients II
Undergoing lifestyle changes (rehabilitation) along daily intake of placebo, 4 capsules twice daily at main meals.
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 Name: Rehabilitation

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

Experimental: Control I
Daily intake of chitosan supplement, 4 capsules twice daily at main meals.
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

Placebo Comparator: Control II
Daily intake of placebo 4 capsules twice daily at main meals.
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




Primary Outcome Measures :
  1. Changes in the Composition of the Gut Microbiota [ Time Frame: Change from Baseline Gut Microbiota Composition at 2 weeks ]
    Analysis of gut microbiota composition from stool samples

  2. Changes in the Composition of the Gut Microbiota [ Time Frame: Change from Baseline Gut Microbiota Composition at 12 weeks ]
    Analysis of gut microbiota composition from stool samples

  3. Changes in the Composition of the Gut Microbiota [ Time Frame: Change from Baseline Gut Microbiota Composition at 14 weeks ]
    Analysis of gut microbiota composition from stool samples

  4. Changes in the Body Mass Index [ Time Frame: Change from Baseline Body Mass Index at 2 weeks ]
    Body mass index calculated by dividing whole body weight by the squared height (kg/m2)

  5. Changes in the Body Mass Index [ Time Frame: Change from Baseline Body Mass Index at 12 weeks ]
    Body mass index calculated by dividing whole body weight by the squared height (kg/m2)

  6. Changes in the Waist-to-Hip ratio [ Time Frame: Change from Baseline Waist-to-Hip ratio at 12 weeks ]
    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

  7. Changes in Total Body Fat Percentage [ Time Frame: Change from Baseline Total Body Fat Percentage at 12 weeks ]
    Bioelectrical Impedance Analysis

  8. Changes in Total Body Fat Percentage (Block 1, both arms) [ Time Frame: Change from Baseline Total Body Fat Percentage at 12 weeks ]
    Dual-Energy X-Ray Absorptiometry (DXA)


Secondary Outcome Measures :
  1. Changes in Abdominal Fat (Block 1, both arms) [ Time Frame: Change from Baseline Abdominal Fat at 12 weeks ]
    Dual-Energy X-Ray Absorptiometry (DXA)

  2. Changes in Lean Body Mass [ Time Frame: Change from Baseline Lean Body Mass at 12 weeks ]
    Bioelectrical Impedance Analysis

  3. Changes in Lean Body Mass (Block 1, both arms) [ Time Frame: Change from Baseline Lean Body Mass at 12 weeks ]
    Dual-Energy X-Ray Absorptiometry (DXA)

  4. Changes in Long Term Blood Glucose Concentrations [ Time Frame: Change from Baseline Long Term Blood Glucose Concentrations at 12 weeks ]
    Measurement of glycated hemoglobin (B-HbAc1)

  5. Changes in Blood Glucose Concentrations [ Time Frame: Change from Baseline Blood Glucose Concentrations at 2 weeks ]
    Measurement of S-Glucose

  6. Changes in Blood Glucose Concentrations [ Time Frame: Change from Baseline Blood Glucose Concentrations at 12 weeks ]
    Measurement of S-Glucose

  7. Changes in Blood Lipide Profile [ Time Frame: Change from Baseline Blood Lipide Profile at 2 weeks ]
    Measurements of S-Cholesterol, S-High-density lipoprotein (HDL) cholesterol, S-Low-density lipoprotein (LDL) cholesterol and S-Triglycerides in blood

  8. Changes in Blood Lipide Profile [ Time Frame: Change from Baseline Blood Lipide Profile at 12 weeks ]
    Measurements of S-Cholesterol, S-High-density lipoprotein (HDL) cholesterol, S-Low-density lipoprotein (LDL) cholesterol and S-Triglycerides in blood

  9. Changes in Inflammation Marker [ Time Frame: Change from Baseline Inflammation Marker at 2 weeks ]
    Measurement of high-sensitivity C-reactive protein (hs-CRP) in blood

  10. Changes in Inflammation Marker [ Time Frame: Change from Baseline Inflammation Marker at 12 weeks ]
    Measurement of high-sensitivity C-reactive protein (hs-CRP) in blood

  11. Changes in Six Minute Walking Distance [ Time Frame: Change from Baseline Six Minute Walking Distance at 12 weeks ]
    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.

  12. Changes in Grip Strength [ Time Frame: Change from Baseline Grip Strength at 12 weeks ]
    Grip-strength measurements, three trials for each hand, mean value calculated

  13. Changes of Satiety Feeling (Block 1, both arms) [ Time Frame: Change from Baseline Satiety Feeling at 12 weeks ]
    Measurements of S-Leptin in blood


Other Outcome Measures:
  1. Changes of Health Status [ Time Frame: Change from Baseline Health Status at 12 weeks ]
    Measured with EQ-5D-5L questionnaire developed by the EuroQol Group. The EQ-5D-5L descriptive system comprises five dimension (5D), each describing a different aspect of current health: Mobility, Self-Care, Usual Activities, Pain/Discomfort and Anxiety/Depression. Each dimension has five response levels (5L): no problems, slight problems, moderate problems, severe problems, unable to/extreme problems. In addition EQ visual analog scale (EQ VAS) records the respondent's overall current health on a vertical VAS, where the endpoints are labelled: "The best health you can imagine" and "The worst health you can imagine".

  2. Changes of Depression Severity [ Time Frame: Changes from Baseline Depression Severity at 12 weeks ]
    Measured with the questionnaire Depression Severity Scale (PHQ-9). It is a self-administered questionnaire with 9 items, each item can be scored from 0 (not at all) to 3 (nearly every day). Total scores can range from 0 to 27. Interpretation of Depression Severity: 0-4 None; 5-9 Mild; 10-14 Moderate; 15-19 Moderately Severe; 20-27 Severe.

  3. Changes of General Anxiety Symptoms [ Time Frame: Changes from Baseline General Anxiety Symptoms and at 12 weeks ]
    Measured with the questionnaire Generalized Anxiety Disorder Scale (GAD-7). It is a self-administered questionnaire with 7 items, each item can be scored from 0 (not at all) to 3 (nearly every day). Items are summed to create a symptom severity score ranging from 0 to 21, higher scores indicating more anxiety symptoms.

  4. Physical Activity [ Time Frame: 12 weeks ]
    Physical activity tracked with "Fitbit Charge 3" activity tracker. Each week following data will be registered: Total steps; Total minutes spent on cardiac heart rate zone; Total minutes spent in fat-burn heart rate zone; Total active minutes; Total sedentary minutes. Average value of each parameter will be used as average physical activity per week.

  5. Changes in Physical Activity [ Time Frame: Changes from First Half (1.- 6. weeks) average Physical Activity at Second Half (7.- 12. weeks) ]
    Physical activity tracked with "Fitbit Charge 3" activity tracker. Each week following data will be registered: Total steps; Total minutes spent on cardiac heart rate zone; Total minutes spent in fat-burn heart rate zone; Total active minutes; Total sedentary minutes.

  6. Physical activity level [ Time Frame: Baseline ]
    Evaluated with "Saltin-Grimby" Physical Activity Level Scale. Self-administered single-item, four level questionnaire. The single question is: How much do you move and exert yourself physically during leisure time? The question refers to the past year. The four levels range from level 1 (Physically inactive) to level 4 (Regular hard physical training for competitive sports)

  7. Changes of Defecation [ Time Frame: Changes from Baseline Defecation at 2 weeks ]
    Stool frequency questioned and consistency evaluated with Bristol Stool Form Scale. Bristol Stool Form Scale is self-administered and categorizes stools in on of seven types, ranging from type 1 (hard lumps) to type 7 (watery diarrhea).

  8. Changes of Defecation [ Time Frame: Changes from Baseline Defecation at 12 weeks ]
    Stool frequency questioned and consistency evaluated with Bristol Stool Form Scale. Bristol Stool Form Scale is self-administered and categorizes stools in on of seven types, ranging from type 1 (hard lumps) to type 7 (watery diarrhea).

  9. Changes of Defecation [ Time Frame: Changes from Baseline Defecation at 14 weeks ]
    Stool frequency questioned and consistency evaluated with Bristol Stool Form Scale. Bristol Stool Form Scale is self-administered and categorizes stools in on of seven types, ranging from type 1 (hard lumps) to type 7 (watery diarrhea).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04551365


Contacts
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Contact: Marta Gudjonsdottir, Ph.D. +354 8679890 martagud@hi.is
Contact: Hildur Thors, MD, MPH +354 5852000 hildurth@reykjalundur.is

Locations
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Iceland
Reykjlalundur, Rehabilitation Center Recruiting
Mosfellsbaer, Iceland, 270
Contact: Marta Guðjónsdóttir, Ph.D.    +354 5852027    marta@reykjalundur.is   
Contact: Hildur Thors    +354 5852033    hildurth@reykjalundur.is   
Principal Investigator: Marta Gudjonsdottir, Ph.D.         
Sub-Investigator: Hildur Thors, MD, MPH         
Sub-Investigator: Hjordis Hardardottir, MD         
Sub-Investigator: Thelma R Runarsdottir, MS         
Sub-Investigator: Ingolfur Kristjansson, MD         
Sponsors and Collaborators
University of Iceland
Matís ohf
Reykjalundur Rehabilitation Center
Primex ehf
Investigators
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Study Director: Sigurlaug Skirnisdottir, Ph.D. Matís ohf
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Responsible Party: Marta Guðjónsdóttir, Assistant professor, University of Iceland
ClinicalTrials.gov Identifier: NCT04551365    
Other Study ID Numbers: UI-MicroFIBERgut
First Posted: September 16, 2020    Key Record Dates
Last Update Posted: September 16, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All individual participant data (non-personally identifiable) will be shared that underlie results in publication
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Marta Guðjónsdóttir, University of Iceland:
Gut Microbiota
Chitosan
Obesity
Body Composition
Body Weight
Health Status
Lifestyle
Defecation
Additional relevant MeSH terms:
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Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Chitosan
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Chelating Agents
Sequestering Agents
Hemostatics
Coagulants