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
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).
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 |
Country | Name | City | State |
---|---|---|---|
Iceland | Reykjalundur, Rehabilitation Center | Mosfellsbaer |
Lead Sponsor | Collaborator |
---|---|
University of Iceland | Matís ohf, Primex ehf, Reykjalundur Rehabilitation Center |
Iceland,
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 |
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