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Fecal Microbial Transplantation and Fiber Supplementation in Participants With Obesity and Metabolic Syndrome.

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ClinicalTrials.gov Identifier: NCT03477916
Recruitment Status : Recruiting
First Posted : March 27, 2018
Last Update Posted : May 10, 2018
Sponsor:
Collaborator:
The Weston A. Price Foundation
Information provided by (Responsible Party):
Karen Madsen, University of Alberta

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 that can cause obesity, there is a new idea that certain gut microbes may also be involved. Patients who are obese tend to have different kinds of gut microbes compared with lean healthy individuals. Previous studies have shown that changing the gut microbes of obese individuals by doing a fecal transplant (FMT) using gut microbes from a lean individual improves insulin resistance. However, the effects were not maintained. In addition, research has highlighted a necessary role for dietary fiber in the maintenance of microbes required for human health and also that increasing dietary fiber can reduce inflammation that is associated with insulin resistance. This project builds on the findings that gut microbes can be modulated by both FMT and dietary fiber supplementation and will examine if combining these two treatments can increase the effectiveness of these treatments.

The objective of this study is to use fecal microbial transplant to change the gut microbes of obese individuals to those seen in lean individuals and then to use fiber supplements to help maintain the beneficial effects. In this study, overweight individuals who have metabolic syndrome will receive a fecal transplant using a pill form and then consume a variety of fiber supplements for 6 weeks. Effects on metabolic parameters, quality of life, weight, and dietary intake will be followed. Microbial composition will be measured in stool samples.


Condition or disease Intervention/treatment Phase
Obesity Metabolic Syndrome Biological: FMT Biological: Placebo FMT Dietary Supplement: Prebiotic Fiber Dietary Supplement: Cellulose Phase 2

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 68 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Fecal Microbial Transplantation and Fiber Supplementation in Participants With Obesity and Metabolic Syndrome.
Actual Study Start Date : April 9, 2018
Estimated Primary Completion Date : April 1, 2020
Estimated Study Completion Date : April 1, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Control (Placebo FMT and cellulose) Biological: Placebo FMT
Placebo fecal microbial transplantation (FMT)

Dietary Supplement: Cellulose
Cellulose

Experimental: FMT only (FMT followed by cellulose) Biological: FMT
fecal microbial transplantation (FMT)

Dietary Supplement: Cellulose
Cellulose

Prebiotic only (Placebo FMT and prebiotic fiber) Biological: Placebo FMT
Placebo fecal microbial transplantation (FMT)

Dietary Supplement: Prebiotic Fiber
combined fiber supplement of resistant starch type 4, acacia gum, and soluble corn fiber

Experimental: FMT + prebiotic fiber Biological: FMT
fecal microbial transplantation (FMT)

Dietary Supplement: Prebiotic Fiber
combined fiber supplement of resistant starch type 4, acacia gum, and soluble corn fiber




Primary Outcome Measures :
  1. insulin sensitivity [ Time Frame: Change between the time of screening and 6 weeks following treatment. ]
    The primary endpoint is the change in insulin sensitivity between the time of screening and 6 weeks following treatment.


Secondary Outcome Measures :
  1. BMI [ Time Frame: Changes between baseline and 6 and 12 weeks ]
    weight and height will be combined to report changes in BMI in kg/m^2 between baseline and 6 and 12 weeks

  2. Waist to hip circumferences [ Time Frame: Changes between baseline and 6 and 12 weeks ]
    Changes in waist to hip circumferences between baseline and 6 and 12 weeks

  3. HbA1C [ Time Frame: Changes between baseline and 6 and 12 weeks ]
    Changes HbA1C between baseline and 6 and 12 weeks

  4. fasting glucose [ Time Frame: Changes between baseline and 6 and 12 weeks ]
    Changes fasting glucose between baseline and 6 and 12 weeks

  5. oral glucose tolerance [ Time Frame: Changes between baseline and 6 and 12 weeks ]
    Changes in oral glucose tolerance between baseline and 6 and 12 weeks

  6. Fasting lipid profile [ Time Frame: Changes between baseline and 6 and 12 weeks ]
    Changes in Fasting lipid profile between baseline and 6 and 12 weeks

  7. blood pressure [ Time Frame: Changes between baseline and 6 and 12 weeks ]
    Changes in blood pressure between baseline and 6 and 12 weeks

  8. EuroQol five dimensions questionnaire (EQ-5D™) [ Time Frame: Changes between baseline and 6 and 12 weeks ]
    Changes in EuroQol five dimensions questionnaire scores to arrive at the participants quality of life between baseline and 6 and 12 weeks

  9. SLIM Hunger and Satiety Questionnaire [ Time Frame: Changes between baseline and 6 and 12 weeks ]
    The SLIM Hunger and satiety questionnaire scores used to arrive at the participants feelings of hunger and satiety. Changes in reported feelings of Hunger and Satiety between baseline and 6 and 12 weeks

  10. serum levels of leptin, adiponectin, ghrelin, CRP, TNF-α, IL-6, LPS, and LPS-binding protein [ Time Frame: Changes between baseline and 6 and 12 weeks ]
    Changes in serum levels of leptin, adiponectin, ghrelin, CRP, TNF-α, IL-6, LPS, and LPS-binding protein between baseline and 6 and 12 weeks

  11. fecal microbiota composition [ Time Frame: Changes between baseline and 6 and 12 weeks ]
    Changes in fecal microbiota composition between baseline and 6 and 12 weeks

  12. stool short chain fatty acid composition [ Time Frame: Changes between baseline and 6 and 12 weeks ]
    Changes in stool short chain fatty acid composition between baseline and 6 and 12 weeks



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 (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:

      1. Fasting triglyceride ≥1.7 (TG) mmol/L (with or without taking a statin or fibrate)
      2. HDL cholesterol <1.03 mmol/L in males or <1.29 mmol/L in females (with or without taking a statin or fibrate)
      3. Established diagnosis of hypertension OR SBP ≥130 or DBP ≥85 mmHg (with or without taking at least one antihypertensive agent).

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03477916


Contacts
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Contact: Basmina Aminzadah, HBSc 7807354912 basmina@ualberta.ca

Locations
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Canada, Alberta
Royal Alexandra Hospital Recruiting
Edmonton, Alberta, Canada, T5H 3V9
Contact: Basmina Aminzadah, HBSc    7807354912    basmina@ualberta.ca   
Principal Investigator: Karen Madsen, PhD         
Sponsors and Collaborators
University of Alberta
The Weston A. Price Foundation
Investigators
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Principal Investigator: Karen Madsen, PhD University of Alberta

Additional Information:
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Responsible Party: Karen Madsen, Director, CEGIIR Professor, Division of Gastroenterology, University of Alberta
ClinicalTrials.gov Identifier: NCT03477916     History of Changes
Other Study ID Numbers: 00076642
First Posted: March 27, 2018    Key Record Dates
Last Update Posted: May 10, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Obesity
Metabolic Syndrome
Syndrome
Disease
Pathologic Processes
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases