MiCrobiome dieT Study

NCT03610477 | Completed

• 1 other identifier: 1610M95982
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

Microbiome

Outcome Measures

Primary Outcomes (2)

• Microbiome composition

  Species-level compositional assessment

  Change from baseline daily for 17 days

• Dietary intake variation

  Collected as 24-hour daily recalls assessed using novel methods for dietary pattern assessment

  Change from baseline daily for 17 days

Study Arms (2)

Medium Chain Triglyceride

ACTIVE COMPARATOR

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

Dietary Supplement: Medium chain triglycerides

Long Chain Triglyceride

PLACEBO COMPARATOR

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

Dietary Supplement: Long chain triglycerides

Interventions

Medium chain triglycerides DIETARY_SUPPLEMENT

Gel capsules, each containing 1 gram

Medium Chain Triglyceride

Long chain triglycerides DIETARY_SUPPLEMENT

Gel capsules, each containing 1 gram

Long Chain Triglyceride

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy adult over 18 years

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Minnesota: lead
• General Mills: collaborator

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, United States

Location

Related Publications (1)

• Johnson AJ, Vangay P, Al-Ghalith GA, Hillmann BM, Ward TL, Shields-Cutler RR, Kim AD, Shmagel AK, Syed AN; Personalized Microbiome Class Students; Walter J, Menon R, Koecher K, Knights D. Daily Sampling Reveals Personalized Diet-Microbiome Associations in Humans. Cell Host Microbe. 2019 Jun 12;25(6):789-802.e5. doi: 10.1016/j.chom.2019.05.005.

  PMID: 31194939 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2018
• First Posted: August 1, 2018
• Study Start: January 1, 2017
• Primary Completion: June 30, 2017
• Study Completion: December 30, 2017
• Last Updated: November 1, 2019

Record last verified: 2019-10

Locations

US (1)