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

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

Interventions

BIOLOGICAL

FMT

fecal microbial transplantation (FMT)

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

DIETARY_SUPPLEMENT

Cellulose

Cellulose

Sponsors & Collaborators

• W. Garfield Weston Foundation

  collaborator UNKNOWN

• University of Alberta

  lead OTHER

Principal Investigators

• Karen Madsen, PhD · University of Alberta

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-04-09

Primary Completion

2020-06-01

Completion

2020-12-31

Countries

• Canada

Study Locations