Role of the Gut Microbiome on Lean Mass and Physical Function in Older Adults
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|ClinicalTrials.gov Identifier: NCT02811445|
Recruitment Status : Active, not recruiting
First Posted : June 23, 2016
Last Update Posted : September 19, 2018
|Condition or disease|
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 I recently reported significant associations between circulating gut bacteria-related metabolites with these outcomes in older adults. Accordingly, my overarching 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, I 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).
|Study Type :||Observational|
|Actual Enrollment :||38 participants|
|Official Title:||Role of the Gut Microbiome and Serum Metabolome on Lean Mass and Physical Function in Older Adults|
|Actual Study Start Date :||May 2016|
|Actual Primary Completion Date :||February 2018|
|Estimated Study Completion Date :||April 1, 2020|
Defined by a short physical performance battery score (SPPB) greater than or equal to 11.
Defined by a short physical performance battery score (SPPB) less than or equal to 7.
- Short physical performance battery score (SPPB) [ Time Frame: Baseline ]
Biospecimen Retention: Samples Without DNA
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02811445
|United States, Massachusetts|
|Boston, Massachusetts, United States, 02118-3129|
|Principal Investigator:||Michael S lustgarten, PhD||Tufts University|