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

Obesity Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04551365
• Other study ID #: UI-MicroFIBERgut
• Status: Recruiting
• Phase: N/A
• Start date: August 15, 2020
• Est. completion date: August 1, 2024

Study information

• Verified date: June 2023
• Source: University of Iceland
• Contact: Marta Gudjonsdottir, Ph.D.
• Phone: +354 8679890
• Email: martagud[@]hi.is
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 148
• Est. completion date: August 1, 2024
• Est. primary completion date: October 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Body Weight
• Lifestyle
• Obesity

Intervention

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

Locations

Country	Name	City	State
Iceland	Reykjalundur, Rehabilitation Center	Mosfellsbaer

Sponsors (4)

Lead Sponsor	Collaborator
University of Iceland	Matís ohf, Primex ehf, Reykjalundur Rehabilitation Center

Country where clinical trial is conducted

Iceland, 

Outcome

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