Clinical trial NCT04551365: MicroFIBERgut: Effects of Lifestyle Changes and Chitosan on Gut Microbiota and Weight Management
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Lifestyle
Keywords: Gut Microbiota
Chitosan
Obesity
Body Composition
Body Weight
Health Status
Lifestyle
Defecation
Lead sponsor: University of Iceland
Sponsor class: OTHER
Collaborators: name: Matís ohf
name: Reykjalundur Rehabilitation Center
name: Primex ehf
First posted: 2020-09-16
Enrollment: 106
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two-block, each with 2 arms; a total of 4 arms
Primary purpose: TREATMENT

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).

Eligibility criteria: 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

Primary outcomes:
measure: Changes in the Composition of the Gut Microbiota
timeFrame: Change from Baseline Gut Microbiota Composition at 2 weeks
measure: Changes in the Composition of the Gut Microbiota
timeFrame: Change from Baseline Gut Microbiota Composition at 12 weeks
measure: Changes in the Composition of the Gut Microbiota
timeFrame: Change from Baseline Gut Microbiota Composition at 14 weeks
measure: Changes in the Body Mass Index
timeFrame: Change from Baseline Body Mass Index at 2 weeks
measure: Changes in the Body Mass Index
timeFrame: Change from Baseline Body Mass Index at 12 weeks
measure: Changes in the Waist-to-Hip ratio
timeFrame: Change from Baseline Waist-to-Hip ratio at 12 weeks
measure: Changes in Total Body Fat Percentage
timeFrame: Change from Baseline Total Body Fat Percentage at 12 weeks
measure: Changes in Total Body Fat Percentage (Block 1, both arms)
timeFrame: Change from Baseline Total Body Fat Percentage at 12 weeks
Secondary outcomes:
measure: Changes in Abdominal Fat (Block 1, both arms)
timeFrame: Change from Baseline Abdominal Fat at 12 weeks
measure: Changes in Lean Body Mass
timeFrame: Change from Baseline Lean Body Mass at 12 weeks
measure: Changes in Lean Body Mass (Block 1, both arms)
timeFrame: Change from Baseline Lean Body Mass at 12 weeks
measure: Changes in Long Term Blood Glucose Concentrations
timeFrame: Change from Baseline Long Term Blood Glucose Concentrations at 12 weeks
measure: Changes in Blood Glucose Concentrations
timeFrame: Change from Baseline Blood Glucose Concentrations at 2 weeks
measure: Changes in Blood Glucose Concentrations
timeFrame: Change from Baseline Blood Glucose Concentrations at 12 weeks
measure: Changes in Blood Lipide Profile
timeFrame: Change from Baseline Blood Lipide Profile at 2 weeks
measure: Changes in Blood Lipide Profile
timeFrame: Change from Baseline Blood Lipide Profile at 12 weeks
measure: Changes in Inflammation Marker
timeFrame: Change from Baseline Inflammation Marker at 2 weeks
measure: Changes in Inflammation Marker
timeFrame: Change from Baseline Inflammation Marker at 12 weeks
measure: Changes in Six Minute Walking Distance
timeFrame: Change from Baseline Six Minute Walking Distance at 12 weeks
measure: Changes in Grip Strength
timeFrame: Change from Baseline Grip Strength at 12 weeks
measure: Changes of Satiety Feeling (Block 1, both arms)
timeFrame: Change from Baseline Satiety Feeling at 12 weeks
Other outcomes:
measure: Changes of Health Status
timeFrame: Change from Baseline Health Status at 12 weeks
measure: Changes of Depression Severity
timeFrame: Changes from Baseline Depression Severity at 12 weeks
measure: Changes of General Anxiety Symptoms
timeFrame: Changes from Baseline General Anxiety Symptoms and at 12 weeks
measure: Physical Activity
timeFrame: 12 weeks
measure: Changes in Physical Activity
timeFrame: Changes from First Half (1.- 6. weeks) average Physical Activity at Second Half (7.- 12. weeks)
measure: Physical activity level
timeFrame: Baseline
measure: Changes of Defecation
timeFrame: Changes from Baseline Defecation at 2 weeks
measure: Changes of Defecation
timeFrame: Changes from Baseline Defecation at 12 weeks
measure: Changes of Defecation
timeFrame: Changes from Baseline Defecation at 14 weeks
Locations:
city: Mosfellsbaer
country: Iceland
facility: Reykjalundur, Rehabilitation Center
Study officials:
affiliation: Matís ohf
name: Sigurlaug Skirnisdottir, Ph.D.
role: STUDY_DIRECTOR
References: