Trial Outcomes & Findings for Role of the Gut Microbiome on Lean Mass and Physical Function in Older Adults (NCT NCT02811445)

Last Updated: 2020-08-06

Results Overview

%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.

Recruitment status

COMPLETED

Target enrollment

29 participants

Primary outcome timeframe

1 month

Results posted on

2020-08-06

Participant Flow

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.

Exclusion criteria included a SPPB score of 9 or 10, a BMI ≥ 35 kg/m2, acute or terminal illness, myocardial infarction in the past 6 months, unstable cardiovascular disease, MMSE score \< 23, blood pressure \> 150/90 mm Hg, androgen therapy in males, estrogen therapy in females, and others.

Participant milestones

Participant milestones
Measure	High Functioning Defined by a short physical performance battery score (SPPB) greater than or equal to 11.	Low Functioning Defined by a short physical performance battery score (SPPB) less than or equal to 7.
Overall Study STARTED	18	11
Overall Study COMPLETED	18	11
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	High Functioning n=18 Participants Defined by a short physical performance battery score (SPPB) greater than or equal to 11.	Low Functioning n=11 Participants Defined by a short physical performance battery score (SPPB) less than or equal to 7.	Total n=29 Participants Total of all reporting groups
Age, Continuous	75.9 years STANDARD_DEVIATION 3.42 • n=18 Participants	77.0 years STANDARD_DEVIATION 4.43 • n=11 Participants	76.3 years STANDARD_DEVIATION 3.79 • n=29 Participants
Sex: Female, Male Female	8 Participants n=18 Participants	5 Participants n=11 Participants	13 Participants n=29 Participants
Sex: Female, Male Male	10 Participants n=18 Participants	6 Participants n=11 Participants	16 Participants n=29 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	18 participants n=18 Participants	11 participants n=11 Participants	29 participants n=29 Participants
BMI	28.7 kg/m^2 STANDARD_DEVIATION 3.5 • n=18 Participants	27.6 kg/m^2 STANDARD_DEVIATION 3.7 • n=11 Participants	28.0 kg/m^2 STANDARD_DEVIATION 3.6 • n=29 Participants
Percentage of whole body lean mass	67.3 Percentage of whole body mass STANDARD_DEVIATION 6.4 • n=18 Participants	62.2 Percentage of whole body mass STANDARD_DEVIATION 6.4 • n=11 Participants	65.7 Percentage of whole body mass STANDARD_DEVIATION 6.6 • n=29 Participants
Short physical performance score (SPPB)	11.5 scores on a scale STANDARD_DEVIATION 0.74 • n=18 Participants	7.64 scores on a scale STANDARD_DEVIATION 1.29 • n=11 Participants	10.1 scores on a scale STANDARD_DEVIATION 2.2 • n=29 Participants
400-meter gait speed	1.13 meters/second STANDARD_DEVIATION 0.16 • n=18 Participants	0.96 meters/second STANDARD_DEVIATION 0.16 • n=11 Participants	1.10 meters/second STANDARD_DEVIATION 0.18 • n=29 Participants
Leg press 1 repetition maximum value	1878 Newtons STANDARD_DEVIATION 677 • n=18 Participants	1407 Newtons STANDARD_DEVIATION 535 • n=11 Participants	1699 Newtons STANDARD_DEVIATION 653 • n=29 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	High Functioning n=18 Participants Defined by a short physical performance battery score (SPPB) greater than or equal to 11.	Low Functioning n=11 Participants Defined by a short physical performance battery score (SPPB) less than or equal to 7.
Percentage of Whole Body Lean Mass (%WBLM)	67.3 % of whole body mass Standard Deviation 6.77	61.9 % of whole body mass Standard Deviation 6.64

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	High Functioning n=18 Participants Defined by a short physical performance battery score (SPPB) greater than or equal to 11.	Low Functioning n=11 Participants Defined by a short physical performance battery score (SPPB) less than or equal to 7.
Physical Function Measurement	11.2 score Standard Deviation 1.1	7.4 score Standard Deviation 1.5

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	High Functioning n=18 Participants Defined by a short physical performance battery score (SPPB) greater than or equal to 11.	Low Functioning n=11 Participants Defined by a short physical performance battery score (SPPB) less than or equal to 7.
400-meter Gait Speed	1.12 meters/second Standard Error 0.16	0.96 meters/second Standard Error 0.19

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	High Functioning n=18 Participants Defined by a short physical performance battery score (SPPB) greater than or equal to 11.	Low Functioning n=11 Participants Defined by a short physical performance battery score (SPPB) less than or equal to 7.
Leg Press 1 Repetition Maximum	1863.9 Newtons Standard Deviation 665.1	1343.2 Newtons Standard Deviation 565.3

Adverse Events

High Functioning

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Low Functioning

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Michael Lustgarten

Tufts University HNRCA

Phone: 617-556-3399

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place