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Completed

NCT Number: NCT04551365

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

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).

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Key information

Conditions

Obesity Body Weight Lifestyle Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Reykjalundur, Rehabilitation Center

Mosfellsbaer, 270, Iceland

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

lifestyle changes

Behavioral

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

Chitosan

Dietary Supplement

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

Placebo

Other

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 outcomes

  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 outcomes

  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 outcomes

  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).

Sponsors and collaborators

Lead sponsor

University of Iceland

Other

Collaborators

  • Matís ohf
  • Primex ehf
  • Reykjalundur Rehabilitation Center

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2023
Study completion
2024
First posted
Sep 16, 2020
Registry last updated
May 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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