Role of the Gut Microbiome on Lean Mass and Physical Function in Older Adults
|ClinicalTrials.gov Identifier: NCT02811445|
Recruitment Status : Completed
First Posted : June 23, 2016
Results First Posted : August 6, 2020
Last Update Posted : August 6, 2020
|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 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).
|Study Type :||Observational|
|Actual Enrollment :||29 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|
|Actual Study Completion Date :||November 1, 2019|
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.
- Percentage of Whole Body Lean Mass (%WBLM) [ Time Frame: 1 month ]%WBLM measured with dual x-ray absorptiometry (DXA). A higher %WBLM is indicative of a higher amount of whole-body lean mass, when compared with lower values.
- Physical Function Measurement [ Time Frame: 1-month ]Short physical performance battery (SPPB) score. The SPPB is a combined measure of physical function that includes balance, a chair stand test (the time required to complete 5 chair stands), and the time needed to walk 4 meters. Each of these 3 tests are scored from 0 to 4. The scores for each individual test are summed, and accordingly, the lowest possible SPPB score would be 0, and the highest would be 12. A score of 12 would indicate good physical function, whereas a score of 0 is indicative of poor physical function.
- 400-meter Gait Speed [ Time Frame: 1-month ]Measurement of 400-meter gait speed at the 1-month study visit compared against baseline. A slower time to walk 400 meters is indicative of worse physical function, when compared with a faster time.
- Leg Press 1 Repetition Maximum [ Time Frame: 1-month ]Measurement of the leg press 1 repetition maximum at the 1-month study visit compared with baseline. The leg press 1 repetition maximum test involves the maximum amount of weight that the participant can push with their legs. A higher value is indicative of higher muscle strength, when compared with lower values.
Biospecimen Retention: Samples Without DNA
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|