An observational study in Sarcopenia, sponsored by Tufts University. Completed at 1 site in United States. Open to participants aged 70 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-08-06.
Sponsored by Tufts University · Observational
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.
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).
1,208 studies on the registry are indexed under Sarcopenia; 402 are open to participants now.
This study's enrollment of 29 is below the median of 120 across 419 observational studies indexed under Sarcopenia.
Browse Sarcopenia studies →Tufts University is the lead sponsor of 225 studies on the registry; 24 are open to participants now.
Of its 10 completed or terminated interventional studies of FDA-regulated products, 7 (70%) have results posted.
Counted across the registry records on this site, refreshed daily.
Older adults (70-85y), BMI \< 35 kg/m2
i) Willing and able to sign the IRB approved informed consent form ii) Male and Female iii) 70-85 years of age iv) BMI ≤ 35 kg/m2 v) Willing to come to the HNRCA laboratory for baseline and 1-month follow-up study visits vi) SPPB ≥ 11 ("High-Functioning", HF; 20 subjects: 10 males, 10 females) vii) 4 ≤ SPPB ≤ 7 ("Low-Functioning", LF; 20 subjects: 10 males, 10 females)
Exclusion Criteria:
i) Non-English speaker ii) Acute or terminal illness iii) Surgery in the past 6 months iv) Lower extremity fracture within the past 6 months v) Myocardial infarction in the past 6 months vi) Coronary artery disease, peripheral vascular disease, previous stroke, or history of transient ischemic attacks vii) Cognitive impairment (MMSE score \< 23) viii) Uncontrolled hypertension (> 160/100 mmHg) ix) Neuromuscular disease or drugs affecting neuromuscular function x) Androgen therapy in males xi) Estrogen therapy in females xii) Significant immune disorder xiii) Kidney Failure xiv) Pancreatic disease xv) Diabetes xvi) Gastrointestinal or malabsorption diseases xvii) History of cholecystectomy xviii) Use of probiotics, prebiotics or antibiotics in the past 3 months xix) The subject has any other condition, which in the opinion of the Investigator, precludes the subject's participation in the trial.
xx) With the goal of matching the HF and LF groups for age, sex,and BMI, subjects may be excluded because their age, sex or BMI puts them outside the range needed for this study.
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)
%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.
Time frame: 1 month
Physical Function Measurement
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.
Time frame: 1-month
400-meter Gait Speed
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.
Time frame: 1-month
Leg Press 1 Repetition Maximum
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.
Time frame: 1-month
Recruitment dates: 5/2016 to 2/2018 at the Tufts University Human Nutrition Research Center on Aging (Boston, MA). Sedentary older adults were recruited from a database of older adults, and via advertisements posted on HNRCA bulletin boards and online media.
| Milestone | High Functioning | Low Functioning |
|---|---|---|
| Started | 18 | 11 |
| Completed | 18 | 11 |
| Not completed | 0 | 0 |
%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.
| % of whole body mass | High Functioning | Low Functioning |
|---|---|---|
| Percentage of Whole Body Lean Mass (%WBLM) | 67.3 ± 6.77 | 61.9 ± 6.64 |
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.
| score | High Functioning | Low Functioning |
|---|---|---|
| Physical Function Measurement | 11.2 ± 1.1 | 7.4 ± 1.5 |
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.
| meters/second | High Functioning | Low Functioning |
|---|---|---|
| 400-meter Gait Speed | 1.12 ± 0.16 | 0.96 ± 0.19 |
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.
| Newtons | High Functioning | Low Functioning |
|---|---|---|
| Leg Press 1 Repetition Maximum | 1863.9 ± 665.1 | 1343.2 ± 565.3 |
Collected over Study participants were observed at two time points that were one month apart (baseline and a 1-month study visit).. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| High Functioning | 0/18 (0%) | 0/18 (0%) | 0/18 (0%) |
| Low Functioning | 0/11 (0%) | 0/11 (0%) | 0/11 (0%) |
| Age, Continuous(years) | High Functioning | Low Functioning | Total |
|---|---|---|---|
| Mean | 75.9 ± 3.42 | 77.0 ± 4.43 | 76.3 ± 3.79 |
| Sex: Female, Male(Participants) | High Functioning | Low Functioning | Total |
|---|---|---|---|
| Female | 8 | 5 | 13 |
| Male | 10 | 6 | 16 |
| Race and Ethnicity Not Collected(Participants) | High Functioning | Low Functioning | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Region of Enrollment(participants) | High Functioning | Low Functioning | Total |
|---|---|---|---|
| United States | 18 | 11 | 29 |
| BMI(kg/m^2) | High Functioning | Low Functioning | Total |
|---|---|---|---|
| Mean | 28.7 ± 3.5 | 27.6 ± 3.7 | 28.0 ± 3.6 |
| Percentage of whole body lean mass(Percentage of whole body mass) | High Functioning | Low Functioning | Total |
|---|---|---|---|
| Mean | 67.3 ± 6.4 | 62.2 ± 6.4 | 65.7 ± 6.6 |
| Short physical performance score (SPPB)(scores on a scale) | High Functioning | Low Functioning | Total |
|---|---|---|---|
| Mean | 11.5 ± 0.74 | 7.64 ± 1.29 | 10.1 ± 2.2 |
| 400-meter gait speed(meters/second) | High Functioning | Low Functioning | Total |
|---|---|---|---|
| Mean | 1.13 ± 0.16 | 0.96 ± 0.16 | 1.10 ± 0.18 |
1 further baseline measures are reported on the registry.
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
This study is completed, as verified in Jul 2020. You cannot join it, but the record below documents what was studied.
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Tufts University