Obesity Clinical Trial
— FMTOfficial title:
Fecal Microbial Transplantation and Fiber Supplementation in Subjects With Obesity and Metabolic Syndrome
Verified date | May 2020 |
Source | University of Alberta |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study is looking at the safety and effectiveness of stool transplant, also known as
Fecal Microbiota Transplantation (FMT) and prebiotic supplementation in the management of
metabolic syndrome.
Metabolic syndrome is a common progressive medical condition that is linked to obesity,
diabetes, and heart disease. Obesity and metabolic syndrome are associated with abnormalities
in gut flora which lead to chronic inflammation. This chronic inflammation is thought to
worsen the insulin resistance and heart disease seen with metabolic syndrome. Current
treatment strategies have shown limited effect, are expensive, and have side effects with
long-term use.
FMT is a one-time treatment that has been shown to replace the abnormal gut flora and improve
metabolic disease by increasing anti-inflammatory short chain fatty acid (SCFA) production.
However, the effects from FMT are not permanent. Prebiotic supplementation is one strategy
that may help to extend the benefits of FMT by helping sustain high SCFA levels. At this
point, it is not known how FMT and prebiotics work together to affect SCFA levels in
participants with metabolic syndrome.
This study will look at this interaction and answer if prebiotic therapy is effective in
prolonging the benefits of FMT in participants with metabolic syndrome.
Status | Completed |
Enrollment | 68 |
Est. completion date | January 16, 2020 |
Est. primary completion date | January 16, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: - • Age = 18 and < 65 years at the time of screening - BMI > 30 - Total body weight fluctuation over the last 6 months less than 10% - Fasting plasma glucose > 5.6 mmol/L OR HgbA1c =5.5% OR patients receiving an antidiabetic medication - At least one of the following: - Fasting triglyceride =1.7 mmol/L OR receiving dyslipidemia medication - HDL cholesterol <1.03 mmol/L in males or <1.29 mmol/L in females OR receiving dyslipidemia medication - Known diagnosis of hypertension OR systolic blood pressure =130 or diastolic blood pressure =85 mmHg OR receiving antihypertension medication Exclusion Criteria: - • Systolic blood pressure =180 or diastolic blood pressure =110 mmHg at screening. - Triglyceride =6 mmol/L. - Acute infectious or inflammatory condition over the presiding 4 weeks. - Current or recent use (Previous 6 months) of insulin for diabetes control. - History of oropharyngeal or significant esophageal dysphagia, inflammatory bowel disease, colon cancer, or colonic polyps with high grade dysplasia. - History of autoimmune conditions or chronic inflammatory condition, such as rheumatoid arthritis, chronic active hepatitis B or C, HIV, chronic pancreatitis, advanced NASH, or liver cirrhosis. - Active malignancy. - Active substance abuse or excessive EtOH (defined as >2 X 8oz drinks/d). |
Country | Name | City | State |
---|---|---|---|
Canada | Royal Alexandra Hospital | Edmonton | Alberta |
Canada | University of Alberta Hospital | Edmonton | Alberta |
Lead Sponsor | Collaborator |
---|---|
University of Alberta | The Weston A. Price Foundation |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Insulin Sensitivity Assessment | The homeostasis Model Assessment-Insulin Resistance (HOMA-IR) is a mathematical model to predict the interaction between glucose and insulin dynamics across a range of glucose plasma levels assuming a feedback circuit between the liver and ß-cells in the pancreas | 12 weeks | |
Secondary | Health-related quality of life (HRQL): EQ-5D Index | Assessment of the current health related quality of life will be accomplished by conducting standardized interviews and by using the validated questionnaires EQ-5D Index. Participants will report perceived health outcomes using this validated survey, and rank overall perceived health from 0 (low)- 100 (high). | 12 week | |
Secondary | Dietary Intake | Dietary intake will be assessed for each clinic using MyFitnessPal. | 12 week | |
Secondary | Inflammatory markers | . Levels of leptin, ghrelin, adiponectin, TNFa, IL-6, LPS (lipopolysaccharide), LPS-binding protein and zonulin will be determined using currently accepted laboratory techniques. | 12 week | |
Secondary | Stool Microbiome | Stool microbiome will be analyzed for Operational Taxonomic Unit determination. | 12 weeks | |
Secondary | Anthropometric Measurements | BMI (kg/m2) | 12 weeks | |
Secondary | Fasting lipid profile | Changes in Fasting lipid profile between baseline and 6 and 12 weeks | 12 weeks | |
Secondary | Glucose Tolerance Assessment | The oral glucose tolerance test (OGTT) is a dynamic test that reflects the efficiency of the body to dispose of glucose after an oral load. It is commonly used in clinical scenarios to diagnose glucose intolerance and diabetes. [33] After overnight fast (> 8 h), blood samples for determination of glucose and insulin concentration will be taken at -5, 0, 30, 60, and 120 min following a standard oral glucose load. | 12 weeks | |
Secondary | Hunger and Satiety Assessment | Assessed via the standardized hunger and satiety questionnaire (categorical variables with no analog scale) | 12 weeks | |
Secondary | Gastrointestinal tolerance | Assessed via the standardized gastrointestinal tolerance questionnaire (categorical variables with no analog scale) | 12 weeks |
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