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

Overview

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).

Full Title of Study: “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

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: June 30, 2022

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).

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

Arms, Groups and Cohorts

  • Experimental: Obese patients I
    • Undergoing lifestyle changes (rehabilitation) along daily intake of chitosan supplement, 4 capsules twice daily at main meals.
  • Placebo Comparator: Obese patients II
    • Undergoing lifestyle changes (rehabilitation) along daily intake of placebo, 4 capsules twice daily at main meals.
  • Experimental: Control I
    • Daily intake of chitosan supplement, 4 capsules twice daily at main meals.
  • Placebo Comparator: Control II
    • Daily intake of placebo 4 capsules twice daily at main meals.

Clinical Trial Outcome Measures

Primary Measures

  • 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
  • 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
  • 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
  • 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)
  • 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)
  • 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
  • Changes in Total Body Fat Percentage
    • Time Frame: Change from Baseline Total Body Fat Percentage at 12 weeks
    • Bioelectrical Impedance Analysis
  • 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 Measures

  • Changes in Abdominal Fat (Block 1, both arms)
    • Time Frame: Change from Baseline Abdominal Fat at 12 weeks
    • Dual-Energy X-Ray Absorptiometry (DXA)
  • Changes in Lean Body Mass
    • Time Frame: Change from Baseline Lean Body Mass at 12 weeks
    • Bioelectrical Impedance Analysis
  • 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)
  • 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)
  • Changes in Blood Glucose Concentrations
    • Time Frame: Change from Baseline Blood Glucose Concentrations at 2 weeks
    • Measurement of S-Glucose
  • Changes in Blood Glucose Concentrations
    • Time Frame: Change from Baseline Blood Glucose Concentrations at 12 weeks
    • Measurement of S-Glucose
  • 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
  • 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
  • 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
  • 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
  • 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.
  • 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
  • Changes of Satiety Feeling (Block 1, both arms)
    • Time Frame: Change from Baseline Satiety Feeling at 12 weeks
    • Measurements of S-Leptin in blood

Participating in This Clinical Trial

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

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • University of Iceland
  • Collaborator
    • Matís ohf
  • Provider of Information About this Clinical Study
    • Principal Investigator: Marta Guðjónsdóttir, Assistant professor – University of Iceland
  • Overall Official(s)
    • Sigurlaug Skirnisdottir, Ph.D., Study Director, Matís ohf
  • Overall Contact(s)
    • Marta Gudjonsdottir, Ph.D., +354 8679890, martagud@hi.is

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