Clinical Trials Directory

Trials / Completed

CompletedNCT02811445

Role of the Gut Microbiome on Lean Mass and Physical Function in Older Adults

Role of the Gut Microbiome and Serum Metabolome on Lean Mass and Physical Function in Older Adults

Status
Completed
Phase
Study type
Observational
Enrollment
29 (actual)
Sponsor
Tufts University · Academic / Other
Sex
All
Age
70 Years – 85 Years
Healthy volunteers
Accepted

Summary

The investigators recently published significant associations between circulating gut bacteria-related metabolites with lean and skeletal muscle mass and with measures of physical function in older adults, evidence that suggests a role for gut bacteria on the maintenance of these outcomes. To date, studies aimed at identification of associations between gut bacteria with lean mass or with specific measures of physical function have yet to be reported. Accordingly, the over-arching hypothesis is that gut bacteria are associated with, and are causatively involved in mechanisms that underlie the maintenance of lean mass and physical function in older adults. Results obtained from the proposed study are intended as the basis for future studies aimed at targeted modulation of the gut microflora, which may be a novel and innovative means for improving lean mass and physical function, and for addressing the public health priority of healthy aging in older adults.

Detailed description

In older adults (70+ years), reduced lean body mass and physical function are associated with increased disability, hospitalization, morbidity and mortality. Because older adults are the fastest growing global subpopulation, identification of mechanisms that underlie the maintenance of lean mass and physical function will be important for addressing the public health priority of healthy aging. Gut bacteria may be involved in mechanisms that underlie the maintenance of lean mass and physical function. In support of this hypothesis, in multiple publications the investigators recently reported significant associations between circulating gut bacteria-related metabolites with these outcomes in older adults. Accordingly, the overarching study hypothesis is that is gut bacteria are associated with, and are causatively involved in mechanisms that underlie the maintenance of lean mass and physical function in older adults. To test this hypothesis, the investigators propose to: characterize the association between fecal bacteria with lean mass and physical function (AIM 1), test the causative role of gut bacteria on the maintenance of lean mass and physical function by colonizing germ-free mice with fecal bacteria from older adults (AIM 2), and examine potential mechanisms that link gut bacteria with these outcomes by identifying associations between gut bacteria and serum metabolites with lean mass and physical function (AIM 3).

Conditions

Timeline

Start date
2016-05-01
Primary completion
2018-02-01
Completion
2019-11-01
First posted
2016-06-23
Last updated
2020-08-06
Results posted
2020-08-06

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT02811445. Inclusion in this directory is not an endorsement.