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

Not Applicable

Completed

• Conditions: Lifestyle; Obesity
• Interventions: Behavioral: Lifestyle changes; Other: Placebo; Dietary Supplement: Chitosan

• Registration Number: NCT04551365
• Lead Sponsor: University of Iceland

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).

Study Timeline

• Study First Submitted: 2020-07-10
• Study Start: 2020-08-15
• Study First Submitted QC: 2020-09-09
• Study First Posted: 2020-09-16
• Primary Completion: 2023-10-30
• Study Completion: 2024-03-15
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-14
• Last Update Posted: 2024-05-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 106

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)

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Obese patients II	Lifestyle changes	Undergoing lifestyle changes (rehabilitation) along daily intake of placebo, 4 capsules twice daily at main meals.
Obese patients I	Chitosan	Undergoing lifestyle changes (rehabilitation) along daily intake of chitosan supplement, 4 capsules twice daily at main meals.
Control II	Placebo	Daily intake of placebo 4 capsules twice daily at main meals.
Obese patients II	Placebo	Undergoing lifestyle changes (rehabilitation) along daily intake of placebo, 4 capsules twice daily at main meals.
Control I	Chitosan	Daily intake of chitosan supplement, 4 capsules twice daily at main meals.
Obese patients I	Lifestyle changes	Undergoing lifestyle changes (rehabilitation) along daily intake of chitosan supplement, 4 capsules twice daily at main meals.

Primary Outcome Measures

Name	Time	Method
Changes in the Body Mass Index	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 Total Body Fat Percentage	Change from Baseline Total Body Fat Percentage at 12 weeks	Bioelectrical Impedance Analysis
Changes in the Waist-to-Hip ratio	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 (Block 1, both arms)	Change from Baseline Total Body Fat Percentage at 12 weeks	Dual-Energy X-Ray Absorptiometry (DXA)
Changes in the Composition of the Gut Microbiota	Change from Baseline Gut Microbiota Composition at 14 weeks	Analysis of gut microbiota composition from stool samples

Secondary Outcome Measures

Name	Time	Method
Changes in Abdominal Fat (Block 1, both arms)	Change from Baseline Abdominal Fat at 12 weeks	Dual-Energy X-Ray Absorptiometry (DXA)
Changes in Lean Body Mass (Block 1, both arms)	Change from Baseline Lean Body Mass at 12 weeks	Dual-Energy X-Ray Absorptiometry (DXA)
Changes in Lean Body Mass	Change from Baseline Lean Body Mass at 12 weeks	Bioelectrical Impedance Analysis
Changes in Long Term Blood Glucose Concentrations	Change from Baseline Long Term Blood Glucose Concentrations at 12 weeks	Measurement of glycated hemoglobin (B-HbAc1)
Changes in Blood Lipide Profile	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 Six Minute Walking Distance	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 Blood Glucose Concentrations	Change from Baseline Blood Glucose Concentrations at 12 weeks	Measurement of S-Glucose
Changes in Inflammation Marker	Change from Baseline Inflammation Marker at 12 weeks	Measurement of high-sensitivity C-reactive protein (hs-CRP) in blood
Changes in Grip Strength	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)	Change from Baseline Satiety Feeling at 12 weeks	Measurements of S-Leptin in blood

Trial Locations

Locations (1)

Reykjalundur, Rehabilitation Center; 🇮🇸 Mosfellsbaer, Iceland