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).
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
106
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
Daily intake of chitosan supplement. Daily dose: 4 capsules(1,5 g chitosan) twice at main meals; total 3 g Duration: 12 weeks
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
Reykjalundur, Rehabilitation Center
Mosfellsbaer, Iceland
Changes in the Composition of the Gut Microbiota
Analysis of gut microbiota composition from stool samples
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: Change from Baseline Waist-to-Hip ratio at 12 weeks
Changes in Total Body Fat Percentage
Bioelectrical Impedance Analysis
Time frame: Change from Baseline Total Body Fat Percentage at 12 weeks
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Changes in Total Body Fat Percentage (Block 1, both arms)
Dual-Energy X-Ray Absorptiometry (DXA)
Time frame: Change from Baseline Total Body Fat Percentage at 12 weeks
Changes in Abdominal Fat (Block 1, both arms)
Dual-Energy X-Ray Absorptiometry (DXA)
Time frame: Change from Baseline Abdominal Fat at 12 weeks
Changes in Lean Body Mass
Bioelectrical Impedance Analysis
Time frame: Change from Baseline Lean Body Mass at 12 weeks
Changes in Lean Body Mass (Block 1, both arms)
Dual-Energy X-Ray Absorptiometry (DXA)
Time frame: Change from Baseline Lean Body Mass at 12 weeks
Changes in Long Term Blood Glucose Concentrations
Measurement of glycated hemoglobin (B-HbAc1)
Time frame: Change from Baseline Long Term Blood Glucose Concentrations at 12 weeks
Changes in Blood Glucose Concentrations
Measurement of S-Glucose
Time frame: Change from Baseline Blood Glucose Concentrations at 2 weeks
Changes in Blood Glucose Concentrations
Measurement of S-Glucose
Time frame: 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
Time frame: 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
Time frame: Change from Baseline Blood Lipide Profile at 12 weeks
Changes in Inflammation Marker
Measurement of high-sensitivity C-reactive protein (hs-CRP) in blood
Time frame: Change from Baseline Inflammation Marker at 2 weeks
Changes in Inflammation Marker
Measurement of high-sensitivity C-reactive protein (hs-CRP) in blood
Time frame: 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.
Time frame: 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
Time frame: Change from Baseline Grip Strength at 12 weeks
Changes of Satiety Feeling (Block 1, both arms)
Measurements of S-Leptin in blood
Time frame: Change from Baseline Satiety Feeling at 12 weeks