MCTs: MiCrobiome dieT Study

Sponsor

University of Minnesota (Other)

Overall Status

Completed

CT.gov ID

NCT03610477

Collaborator

General Mills (Industry)

Enrollment

Location

Arms

11.9

Actual Duration (Months)

2.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The human gut microbiome is the community of bacteria that reside within the human intestine. These microbes are constantly exposed to the end-products and partial break-down-products of digestion from the foods consumed each day. Very little is known about the complex interaction of specific dietary components with the microbiome over time in one individual. In order to produce robust analysis of these interactions, longitudinal samples with detailed dietary intake information from healthy human subjects are needed.

The complex relationship between dietary intake and the microbiome, and the potential health implications of human exposure to microbial metabolites, are only beginning to be understood. It is well known that altered dietary intake can trigger rapid, although transient, changes in the composition of the microbiome in as little as 1 to 2 days. The biggest factors in determining microbial response to diet are thought to include an individual's starting microbiome, long-term dietary habits, and environmental exposures.

It is not well understood how small dietary differences from day-to-day impact the microbiome. A longitudinal dataset with accurately recorded dietary data and multiple samples over 17 days will provide valuable insight into the changes that occur at the individual level over time, while controlling for dietary trends and initial microbiome composition.

Medium chain triglycerides (MCTs) have systemic beneficial effects and increase survival in rats by preventing gut injury and permeability following lipopolysaccharide administration, preventing alcohol-induced liver injury, and protecting against the development of colitis in a model of Crohn's disease. Understanding the interaction of MCTs with the microbiome in humans could lead to important advancements in the understanding of how diet impacts the microbiome composition, and ultimately, human health. This proposed study is designed to evaluate the effect of MCTs compared with long chain triglycerides on the normal structure of the microbiome and data will not be used to diagnose, prevent, cure or treat disease.

The purpose of this study is to: 1) investigate the role daily dietary variation plays in microbiome composition and stability, and 2) explore the effect of MCT supplementation on microbiome composition in healthy adults.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Dietary Supplement: Medium chain triglycerides Dietary Supplement: Long chain triglycerides	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

34 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Basic Science

Official Title:

Effect of Normal Dietary Intake and Medium Chain Triglycerides Supplementation on the Human Microbiome

Actual Study Start Date :

Jan 1, 2017

Actual Primary Completion Date :

Jun 30, 2017

Actual Study Completion Date :

Dec 30, 2017

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Medium Chain Triglyceride Participants will be randomized to consume 5% of total energy intake from medium chain triglycerides.	Dietary Supplement: Medium chain triglycerides Gel capsules, each containing 1 gram
Placebo Comparator: Long Chain Triglyceride Participants will be randomized to consume 5% of total energy intake from long chain triglycerides.	Dietary Supplement: Long chain triglycerides Gel capsules, each containing 1 gram

Arm

Intervention/Treatment

Active Comparator: Medium Chain Triglyceride

Participants will be randomized to consume 5% of total energy intake from medium chain triglycerides.

Dietary Supplement: Medium chain triglycerides

Gel capsules, each containing 1 gram

Placebo Comparator: Long Chain Triglyceride

Participants will be randomized to consume 5% of total energy intake from long chain triglycerides.

Dietary Supplement: Long chain triglycerides

Gel capsules, each containing 1 gram

Outcome Measures

Primary Outcome Measures

Microbiome composition [Change from baseline daily for 17 days]
Species-level compositional assessment
Dietary intake variation [Change from baseline daily for 17 days]
Collected as 24-hour daily recalls assessed using novel methods for dietary pattern assessment

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Healthy adult over 18 years

Exclusion Criteria:

Type 1 diabetes mellitus or insulin dependent type II diabetes mellitus
Individuals currently maintaining a ketogenic diet
Women who are currently pregnant or breast feeding
Use of antibiotics in the last 3 months
Self-reported pre-existing history of liver disease e.g. cirrhosis or diagnosed fatty liver disease.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Minnesota	Minneapolis	Minnesota	United States

Sponsors and Collaborators

University of Minnesota
General Mills

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University of Minnesota

ClinicalTrials.gov Identifier:

NCT03610477

Other Study ID Numbers:

1610M95982

First Posted:

Aug 1, 2018

Last Update Posted:

Nov 1, 2019

Last Verified:

Oct 1, 2019

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by University of Minnesota

Microbiome

Study Results

No Results Posted as of Nov 1, 2019