Status:
COMPLETED
Fecal Microbial Transplantation and Fiber Supplementation in Participants With Obesity and Metabolic Syndrome.
Lead Sponsor:
University of Alberta
Collaborating Sponsors:
W. Garfield Weston Foundation
Conditions:
Obesity
Metabolic Syndrome
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
Obesity is increasing in western society at a rapid rate and is associated with metabolic and cardiovascular disease. Although genetics, improper diet, and sedentary lifestyle are known to be factors ...
Detailed Description
Phase: This is a phase II clinical trial. Methodology: This is an exploratory, four-arm, parallel design, randomized placebo-controlled intervention study. Study Duration: 12 weeks Study Center(s): ...
Eligibility Criteria
Inclusion
- • 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 (FPG): 1) \> 5.6 mmol/L OR Hemoglobin A1c ≥6.5% (with or without taking an oral antidiabetic medication).
- At least one of the following criterion:
- Fasting triglyceride ≥1.7 (TG) mmol/L (with or without taking a statin or fibrate)
- HDL cholesterol \<1.03 mmol/L in males or \<1.29 mmol/L in females (with or without taking a statin or fibrate)
- Established diagnosis of hypertension OR SBP ≥130 or DBP ≥85 mmHg (with or without taking at least one antihypertensive agent).
Exclusion
- • 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).
Key Trial Info
Start Date :
April 9 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2020
Estimated Enrollment :
68 Patients enrolled
Trial Details
Trial ID
NCT03477916
Start Date
April 9 2018
End Date
December 31 2020
Last Update
January 5 2022
Active Locations (1)
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1
Royal Alexandra Hospital
Edmonton, Alberta, Canada, T5H 3V9