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

NCT03477916 | Completed Phase 2 DMC

• 1 other identifier: 00076642
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity; Metabolic Syndrome

Outcome Measures

Primary Outcomes (1)

• insulin sensitivity

  The primary endpoint is the change in insulin sensitivity between the time of screening and 6 weeks following treatment.

  Change between the time of screening and 6 weeks following treatment.

Secondary Outcomes (12)

• BMI

  Changes between baseline and 6 and 12 weeks

• Waist to hip circumferences

  Changes between baseline and 6 and 12 weeks

• HbA1C

  Changes between baseline and 6 and 12 weeks

• fasting glucose

  Changes between baseline and 6 and 12 weeks

• oral glucose tolerance

  Changes between baseline and 6 and 12 weeks

Study Arms (4)

Control (Placebo FMT and cellulose)

OTHER

Biological: Placebo FMT; Dietary Supplement: Cellulose

FMT only (FMT followed by cellulose)

EXPERIMENTAL

Biological: FMT; Dietary Supplement: Cellulose

Prebiotic only (Placebo FMT and prebiotic fiber)

OTHER

Biological: Placebo FMT; Dietary Supplement: Prebiotic Fiber

FMT + prebiotic fiber

EXPERIMENTAL

Biological: FMT; Dietary Supplement: Prebiotic Fiber

Interventions

FMT BIOLOGICAL

fecal microbial transplantation (FMT)

FMT + prebiotic fiber; FMT only (FMT followed by cellulose)

Placebo FMT BIOLOGICAL

Placebo fecal microbial transplantation (FMT)

Control (Placebo FMT and cellulose); Prebiotic only (Placebo FMT and prebiotic fiber)

Prebiotic Fiber DIETARY_SUPPLEMENT

combined fiber supplement of resistant starch type 4, acacia gum, and soluble corn fiber

FMT + prebiotic fiber; Prebiotic only (Placebo FMT and prebiotic fiber)

Cellulose DIETARY_SUPPLEMENT

Cellulose

Control (Placebo FMT and cellulose); FMT only (FMT followed by cellulose)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Alberta: lead
• W. Garfield Weston Foundation: collaborator

Study Sites (1)

Royal Alexandra Hospital

Edmonton, Alberta, T5H 3V9, Canada

Location

Related Publications (1)

• Mocanu V, Zhang Z, Deehan EC, Kao DH, Hotte N, Karmali S, Birch DW, Samarasinghe KK, Walter J, Madsen KL. Fecal microbial transplantation and fiber supplementation in patients with severe obesity and metabolic syndrome: a randomized double-blind, placebo-controlled phase 2 trial. Nat Med. 2021 Jul;27(7):1272-1279. doi: 10.1038/s41591-021-01399-2. Epub 2021 Jul 5.

  PMID: 34226737 RESULT

MeSH Terms

Conditions

Obesity; Metabolic Syndrome

Interventions

Cellulose

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases

Intervention Hierarchy (Ancestors)

Glucans; Biopolymers; Polymers; Macromolecular Substances; Polysaccharides; Carbohydrates; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Karen Madsen, PhD

  University of Alberta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, CEGIIR Professor, Division of Gastroenterology

Study Record Dates

• First Submitted: March 12, 2018
• First Posted: March 27, 2018
• Study Start: April 9, 2018
• Primary Completion: June 1, 2020
• Study Completion: December 31, 2020
• Last Updated: January 5, 2022

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)