MicroFIBERgut: Effects of Lifestyle Changes and Chitosan on Gut Microbiota and Weight Management
Primary Purpose
Obesity, Lifestyle
Status
Recruiting
Phase
Not Applicable
Locations
Iceland
Study Type
Interventional
Intervention
Lifestyle changes
Chitosan
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Obesity focused on measuring Gut Microbiota, Chitosan, Obesity, Body Composition, Body Weight, Health Status, Lifestyle, Defecation
Eligibility 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
Sites / Locations
- Reykjalundur, Rehabilitation CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Placebo Comparator
Experimental
Placebo Comparator
Arm Label
Obese patients I
Obese patients II
Control I
Control II
Arm Description
Undergoing lifestyle changes (rehabilitation) along daily intake of chitosan supplement, 4 capsules twice daily at main meals.
Undergoing lifestyle changes (rehabilitation) along daily intake of placebo, 4 capsules twice daily at main meals.
Daily intake of chitosan supplement, 4 capsules twice daily at main meals.
Daily intake of placebo 4 capsules twice daily at main meals.
Outcomes
Primary Outcome Measures
Changes in the Composition of the Gut Microbiota
Analysis of gut microbiota composition from stool samples
Changes in the Composition of the Gut Microbiota
Analysis of gut microbiota composition from stool samples
Changes in the Composition of the Gut Microbiota
Analysis of gut microbiota composition from stool samples
Changes in the Body Mass Index
Body mass index calculated by dividing whole body weight by the squared height (kg/m2)
Changes in the Body Mass Index
Body mass index calculated by dividing whole body weight by the squared height (kg/m2)
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
Changes in Total Body Fat Percentage
Bioelectrical Impedance Analysis
Changes in Total Body Fat Percentage (Block 1, both arms)
Dual-Energy X-Ray Absorptiometry (DXA)
Secondary Outcome Measures
Changes in Abdominal Fat (Block 1, both arms)
Dual-Energy X-Ray Absorptiometry (DXA)
Changes in Lean Body Mass
Bioelectrical Impedance Analysis
Changes in Lean Body Mass (Block 1, both arms)
Dual-Energy X-Ray Absorptiometry (DXA)
Changes in Long Term Blood Glucose Concentrations
Measurement of glycated hemoglobin (B-HbAc1)
Changes in Blood Glucose Concentrations
Measurement of S-Glucose
Changes in Blood Glucose Concentrations
Measurement of S-Glucose
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
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
Changes in Inflammation Marker
Measurement of high-sensitivity C-reactive protein (hs-CRP) in blood
Changes in Inflammation Marker
Measurement of high-sensitivity C-reactive protein (hs-CRP) in blood
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.
Changes in Grip Strength
Grip-strength measurements, three trials for each hand, mean value calculated
Changes of Satiety Feeling (Block 1, both arms)
Measurements of S-Leptin in blood
Full Information
NCT ID
NCT04551365
First Posted
July 10, 2020
Last Updated
June 19, 2023
Sponsor
University of Iceland
Collaborators
Matís ohf, Reykjalundur Rehabilitation Center, Primex ehf
1. Study Identification
Unique Protocol Identification Number
NCT04551365
Brief Title
MicroFIBERgut: Effects of Lifestyle Changes and Chitosan on Gut Microbiota and Weight Management
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 15, 2020 (Actual)
Primary Completion Date
October 30, 2023 (Anticipated)
Study Completion Date
August 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Iceland
Collaborators
Matís ohf, Reykjalundur Rehabilitation Center, Primex ehf
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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).
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Lifestyle
Keywords
Gut Microbiota, Chitosan, Obesity, Body Composition, Body Weight, Health Status, Lifestyle, Defecation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Two-block, each with 2 arms; a total of 4 arms
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
148 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Obese patients I
Arm Type
Experimental
Arm Description
Undergoing lifestyle changes (rehabilitation) along daily intake of chitosan supplement, 4 capsules twice daily at main meals.
Arm Title
Obese patients II
Arm Type
Placebo Comparator
Arm Description
Undergoing lifestyle changes (rehabilitation) along daily intake of placebo, 4 capsules twice daily at main meals.
Arm Title
Control I
Arm Type
Experimental
Arm Description
Daily intake of chitosan supplement, 4 capsules twice daily at main meals.
Arm Title
Control II
Arm Type
Placebo Comparator
Arm Description
Daily intake of placebo 4 capsules twice daily at main meals.
Intervention Type
Behavioral
Intervention Name(s)
Lifestyle changes
Other Intervention Name(s)
Rehabilitation
Intervention Description
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
Dietary Supplement
Intervention Name(s)
Chitosan
Intervention Description
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
Other
Intervention Name(s)
Placebo
Intervention Description
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 Measure Information:
Title
Changes in the Composition of the Gut Microbiota
Description
Analysis of gut microbiota composition from stool samples
Time Frame
Change from Baseline Gut Microbiota Composition at 2 weeks
Title
Changes in the Composition of the Gut Microbiota
Description
Analysis of gut microbiota composition from stool samples
Time Frame
Change from Baseline Gut Microbiota Composition at 12 weeks
Title
Changes in the Composition of the Gut Microbiota
Description
Analysis of gut microbiota composition from stool samples
Time Frame
Change from Baseline Gut Microbiota Composition at 14 weeks
Title
Changes in the Body Mass Index
Description
Body mass index calculated by dividing whole body weight by the squared height (kg/m2)
Time Frame
Change from Baseline Body Mass Index at 2 weeks
Title
Changes in the Body Mass Index
Description
Body mass index calculated by dividing whole body weight by the squared height (kg/m2)
Time Frame
Change from Baseline Body Mass Index at 12 weeks
Title
Changes in the Waist-to-Hip ratio
Description
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
Time Frame
Change from Baseline Waist-to-Hip ratio at 12 weeks
Title
Changes in Total Body Fat Percentage
Description
Bioelectrical Impedance Analysis
Time Frame
Change from Baseline Total Body Fat Percentage at 12 weeks
Title
Changes in Total Body Fat Percentage (Block 1, both arms)
Description
Dual-Energy X-Ray Absorptiometry (DXA)
Time Frame
Change from Baseline Total Body Fat Percentage at 12 weeks
Secondary Outcome Measure Information:
Title
Changes in Abdominal Fat (Block 1, both arms)
Description
Dual-Energy X-Ray Absorptiometry (DXA)
Time Frame
Change from Baseline Abdominal Fat at 12 weeks
Title
Changes in Lean Body Mass
Description
Bioelectrical Impedance Analysis
Time Frame
Change from Baseline Lean Body Mass at 12 weeks
Title
Changes in Lean Body Mass (Block 1, both arms)
Description
Dual-Energy X-Ray Absorptiometry (DXA)
Time Frame
Change from Baseline Lean Body Mass at 12 weeks
Title
Changes in Long Term Blood Glucose Concentrations
Description
Measurement of glycated hemoglobin (B-HbAc1)
Time Frame
Change from Baseline Long Term Blood Glucose Concentrations at 12 weeks
Title
Changes in Blood Glucose Concentrations
Description
Measurement of S-Glucose
Time Frame
Change from Baseline Blood Glucose Concentrations at 2 weeks
Title
Changes in Blood Glucose Concentrations
Description
Measurement of S-Glucose
Time Frame
Change from Baseline Blood Glucose Concentrations at 12 weeks
Title
Changes in Blood Lipide Profile
Description
Measurements of S-Cholesterol, S-High-density lipoprotein (HDL) cholesterol, S-Low-density lipoprotein (LDL) cholesterol and S-Triglycerides in blood
Time Frame
Change from Baseline Blood Lipide Profile at 2 weeks
Title
Changes in Blood Lipide Profile
Description
Measurements of S-Cholesterol, S-High-density lipoprotein (HDL) cholesterol, S-Low-density lipoprotein (LDL) cholesterol and S-Triglycerides in blood
Time Frame
Change from Baseline Blood Lipide Profile at 12 weeks
Title
Changes in Inflammation Marker
Description
Measurement of high-sensitivity C-reactive protein (hs-CRP) in blood
Time Frame
Change from Baseline Inflammation Marker at 2 weeks
Title
Changes in Inflammation Marker
Description
Measurement of high-sensitivity C-reactive protein (hs-CRP) in blood
Time Frame
Change from Baseline Inflammation Marker at 12 weeks
Title
Changes in Six Minute Walking Distance
Description
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.
Time Frame
Change from Baseline Six Minute Walking Distance at 12 weeks
Title
Changes in Grip Strength
Description
Grip-strength measurements, three trials for each hand, mean value calculated
Time Frame
Change from Baseline Grip Strength at 12 weeks
Title
Changes of Satiety Feeling (Block 1, both arms)
Description
Measurements of S-Leptin in blood
Time Frame
Change from Baseline Satiety Feeling at 12 weeks
Other Pre-specified Outcome Measures:
Title
Changes of Health Status
Description
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".
Time Frame
Change from Baseline Health Status at 12 weeks
Title
Changes of Depression Severity
Description
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.
Time Frame
Changes from Baseline Depression Severity at 12 weeks
Title
Changes of General Anxiety Symptoms
Description
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.
Time Frame
Changes from Baseline General Anxiety Symptoms and at 12 weeks
Title
Physical Activity
Description
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.
Time Frame
12 weeks
Title
Changes in Physical Activity
Description
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.
Time Frame
Changes from First Half (1.- 6. weeks) average Physical Activity at Second Half (7.- 12. weeks)
Title
Physical activity level
Description
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)
Time Frame
Baseline
Title
Changes of Defecation
Description
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).
Time Frame
Changes from Baseline Defecation at 2 weeks
Title
Changes of Defecation
Description
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).
Time Frame
Changes from Baseline Defecation at 12 weeks
Title
Changes of Defecation
Description
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).
Time Frame
Changes from Baseline Defecation at 14 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marta Gudjonsdottir, Ph.D.
Phone
+354 8679890
Email
martagud@hi.is
First Name & Middle Initial & Last Name or Official Title & Degree
Hildur Thors, MD, MPH
Phone
+354 5852000
Email
hildurth@reykjalundur.is
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sigurlaug Skirnisdottir, Ph.D.
Organizational Affiliation
Matís ohf
Official's Role
Study Director
Facility Information:
Facility Name
Reykjalundur, Rehabilitation Center
City
Mosfellsbaer
ZIP/Postal Code
270
Country
Iceland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marta Guðjónsdóttir, Ph.D.
Phone
+354 5852027
Email
marta@reykjalundur.is
First Name & Middle Initial & Last Name & Degree
Hildur Thors
Phone
+354 5852033
Email
hildurth@reykjalundur.is
First Name & Middle Initial & Last Name & Degree
Marta Gudjonsdottir, Ph.D.
First Name & Middle Initial & Last Name & Degree
Hildur Thors, MD, MPH
First Name & Middle Initial & Last Name & Degree
Hjordis Hardardottir, MD
First Name & Middle Initial & Last Name & Degree
Thelma R Runarsdottir, MS
First Name & Middle Initial & Last Name & Degree
Ingolfur Kristjansson, MD
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
All individual participant data (non-personally identifiable) will be shared that underlie results in publication
IPD Sharing Time Frame
Generally, data will be made available six months after the publication of each study.
IPD Sharing Access Criteria
Data sharing request will be handled by the corresponding author of each publication.
Learn more about this trial
MicroFIBERgut: Effects of Lifestyle Changes and Chitosan on Gut Microbiota and Weight Management
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