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

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).

Study Overview

• Status: Recruiting
• Conditions: Obesity; Lifestyle
• Intervention / Treatment: Behavioral: Lifestyle changes; Dietary supplement: Chitosan; Other: Placebo

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).

• Study Type: Interventional
• Enrollment (Estimated): 148
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Marta Gudjonsdottir, Ph.D.; Phone Number: +354 8679890; Email: martagud@hi.is
• Study Contact Backup: Name: Hildur Thors, MD, MPH; Phone Number: +354 5852000; Email: hildurth@reykjalundur.is

Study Locations

• Iceland
  • Mosfellsbaer, Iceland, 270
    • Recruiting
    • Reykjalundur, Rehabilitation Center
    • Contact: Marta Guðjónsdóttir, Ph.D.; Phone Number: +354 5852027; Email: marta@reykjalundur.is
    • Contact: Hildur Thors; Phone Number: +354 5852033; Email: 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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / 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 Names: 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 Names: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in Abdominal Fat (Block 1, both arms)	Dual-Energy X-Ray Absorptiometry (DXA)	Change from Baseline Abdominal Fat at 12 weeks
Changes in Lean Body Mass	Bioelectrical Impedance Analysis	Change from Baseline Lean Body Mass at 12 weeks
Changes in Lean Body Mass (Block 1, both arms)	Dual-Energy X-Ray Absorptiometry (DXA)	Change from Baseline Lean Body Mass at 12 weeks
Changes in Long Term Blood Glucose Concentrations	Measurement of glycated hemoglobin (B-HbAc1)	Change from Baseline Long Term Blood Glucose Concentrations at 12 weeks
Changes in Blood Glucose Concentrations	Measurement of S-Glucose	Change from Baseline Blood Glucose Concentrations at 2 weeks
Changes in Blood Glucose Concentrations	Measurement of S-Glucose	Change from Baseline Blood Glucose Concentrations at 12 weeks
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	Change from Baseline Blood Lipide Profile at 2 weeks
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	Change from Baseline Blood Lipide Profile at 12 weeks
Changes in Inflammation Marker	Measurement of high-sensitivity C-reactive protein (hs-CRP) in blood	Change from Baseline Inflammation Marker at 2 weeks
Changes in Inflammation Marker	Measurement of high-sensitivity C-reactive protein (hs-CRP) in blood	Change from Baseline Inflammation Marker at 12 weeks
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.	Change from Baseline Six Minute Walking Distance at 12 weeks
Changes in Grip Strength	Grip-strength measurements, three trials for each hand, mean value calculated	Change from Baseline Grip Strength at 12 weeks
Changes of Satiety Feeling (Block 1, both arms)	Measurements of S-Leptin in blood	Change from Baseline Satiety Feeling at 12 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes of Health Status	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".	Change from Baseline Health Status at 12 weeks
Changes of Depression Severity	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.	Changes from Baseline Depression Severity at 12 weeks
Changes of General Anxiety Symptoms	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.	Changes from Baseline General Anxiety Symptoms and at 12 weeks
Physical Activity	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.	12 weeks
Changes in Physical Activity	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.	Changes from First Half (1.- 6. weeks) average Physical Activity at Second Half (7.- 12. weeks)
Physical activity level	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)	Baseline
Changes of Defecation	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).	Changes from Baseline Defecation at 2 weeks
Changes of Defecation	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).	Changes from Baseline Defecation at 12 weeks
Changes of Defecation	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).	Changes from Baseline Defecation at 14 weeks

Collaborators and Investigators

• Sponsor: University of Iceland
• Collaborators: Primex ehf; Matís ohf; Reykjalundur Rehabilitation Center
• Investigators: Study Director: Sigurlaug Skirnisdottir, Ph.D., Matís ohf

Study record dates

Study Major Dates

• Study Start (Actual): August 15, 2020
• Primary Completion (Estimated): October 30, 2023
• Study Completion (Estimated): August 1, 2024

Study Registration Dates

• First Submitted: July 10, 2020
• First Submitted That Met QC Criteria: September 9, 2020
• First Posted (Actual): September 16, 2020

Study Record Updates

• Last Update Posted (Actual): June 22, 2023
• Last Update Submitted That Met QC Criteria: June 19, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Obesity; Health Status; Body Composition; Body Weight; Gut Microbiota; Lifestyle; Chitosan; Defecation
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Obesity; Body Weight; Molecular Mechanisms of Pharmacological Action; Antimetabolites; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Hemostatics; Coagulants; Chelating Agents; Sequestering Agents; Chitosan
• Other Study ID Numbers: UI-MicroFIBERgut

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No