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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02811445
Recruitment Status : Completed
First Posted : June 23, 2016
Results First Posted : August 6, 2020
Last Update Posted : August 6, 2020
Sponsor:
Information provided by (Responsible Party):
Michael, Tufts University

Brief 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.

Condition or disease
Sarcopenia

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).

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Study Type : Observational
Actual Enrollment : 29 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Health Checkup

Group/Cohort
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.



Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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
Feces, Serum


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Ages Eligible for Study:   70 Years to 85 Years   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Older adults (70-85y), BMI < 35 kg/m2
Criteria

Inclusion Criteria:

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02811445


Locations
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United States, Massachusetts
Tufts University
Boston, Massachusetts, United States, 02118-3129
Sponsors and Collaborators
Tufts University
Investigators
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Principal Investigator: Michael S lustgarten, PhD Tufts University
  Study Documents (Full-Text)

Documents provided by Michael, Tufts University:
Statistical Analysis Plan  [PDF] July 23, 2018

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Responsible Party: Michael, Scientist II, Tufts University
ClinicalTrials.gov Identifier: NCT02811445    
Other Study ID Numbers: GRANT11960287
First Posted: June 23, 2016    Key Record Dates
Results First Posted: August 6, 2020
Last Update Posted: August 6, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Michael, Tufts University:
microbiome, metabolome, aging, lean mass, physical function
Additional relevant MeSH terms:
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Sarcopenia
Muscular Atrophy
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Atrophy
Pathological Conditions, Anatomical