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| Name | Class |
|---|---|
| MatÃs ohf | UNKNOWN |
| Reykjalundur Rehabilitation Center | UNKNOWN |
| Primex ehf | INDUSTRY |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Obese patients I | Experimental | Undergoing lifestyle changes (rehabilitation) along daily intake of chitosan supplement, 4 capsules twice daily at main meals. |
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| Obese patients II | Placebo Comparator | Undergoing lifestyle changes (rehabilitation) along daily intake of placebo, 4 capsules twice daily at main meals. |
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| Control I | Experimental | Daily intake of chitosan supplement, 4 capsules twice daily at main meals. |
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| Control II | Placebo Comparator | Daily intake of placebo 4 capsules twice daily at main meals. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| Changes in Total Body Fat Percentage |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Abdominal Fat (Block 1, both arms) | Dual-Energy X-Ray Absorptiometry (DXA) | Change from Baseline Abdominal Fat at 12 weeks |
| Changes in Lean Body Mass | Bioelectrical Impedance Analysis |
| Measure | Description | Time Frame |
|---|---|---|
| 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". |
Inclusion Criteria:
Block 1
Block 2
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sigurlaug Skirnisdottir, Ph.D. | MatÃs ohf | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Reykjalundur, Rehabilitation Center | Mosfellsbaer | 270 | Iceland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40484808 | Derived | Runarsdottir TR, Skirnisdottir S, Thors H, Harethardottir H, Corral-Jara KF, Klonowski AM, Halldorsson ThornI, Marteinsson VThorn, Guethjonsdottir M. The Effect of Chitosan Supplementation on the Gut Microbiota and Various Health Factors in Icelandic Females: A Placebo-Controlled, Double-Blind, Randomized Trial. Mol Nutr Food Res. 2025 Oct;69(19):e70137. doi: 10.1002/mnfr.70137. Epub 2025 Jun 8. |
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All individual participant data (non-personally identifiable) will be shared that underlie results in publication
Generally, data will be made available six months after the publication of each study.
Data sharing request will be handled by the corresponding author of each publication.
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D001835 | Body Weight |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D012046 | Rehabilitation |
| D048271 | Chitosan |
| ID | Term |
|---|---|
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
| D013812 | Therapeutics |
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Two-block, each with 2 arms; a total of 4 arms
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|
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| 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 |
|
Bioelectrical Impedance Analysis |
| Change from Baseline Total Body Fat Percentage at 12 weeks |
| 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 |
| Change from Baseline Lean Body Mass at 12 weeks |
| Changes in Lean Body Mass (Block 1, both arms) | Dual-Energy X-Ray Absorptiometry (DXA) | Change from Baseline Lean Body Mass at 12 weeks |
| Changes in Long Term Blood Glucose Concentrations | Measurement of glycated hemoglobin (B-HbAc1) | Change from Baseline Long Term Blood Glucose Concentrations at 12 weeks |
| Changes in Blood Glucose Concentrations | Measurement of S-Glucose | Change from Baseline Blood Glucose Concentrations at 2 weeks |
| Changes in Blood Glucose Concentrations | Measurement of S-Glucose | 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 | 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 | Change from Baseline Blood Lipide Profile at 12 weeks |
| Changes in Inflammation Marker | Measurement of high-sensitivity C-reactive protein (hs-CRP) in blood | Change from Baseline Inflammation Marker at 2 weeks |
| Changes in Inflammation Marker | Measurement of high-sensitivity C-reactive protein (hs-CRP) in blood | 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. | 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 | Change from Baseline Grip Strength at 12 weeks |
| Changes of Satiety Feeling (Block 1, both arms) | Measurements of S-Leptin in blood | Change from Baseline Satiety Feeling at 12 weeks |
| Change from Baseline Health Status at 12 weeks |
| 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 |
| 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 |
| 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 |
| 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) |
| 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 |
| 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 |
| 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 |
| 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 |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006296 |
| Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D002686 | Chitin |
| D001704 | Biopolymers |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |