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

NCT02811445 | Completed Results

• 1 other identifier: GRANT11960287
• Study Type: observational
• Target: 29
• Locations: 1 country
• Sites: 1

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.

Conditions

Sarcopenia

Keywords

microbiome, metabolome, aging, lean mass, physical function

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  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.

  1-month

Study Arms (2)

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.

Eligibility Criteria

• Age: 70 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Older adults (70-85y), BMI \< 35 kg/m2

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tufts University: lead

Study Sites (1)

Tufts University

Boston, Massachusetts, 02118-3129, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Feces, Serum

MeSH Terms

Conditions

Sarcopenia

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Results Point of Contact

• Title: Michael Lustgarten
• Organization: Tufts University HNRCA

Michael.Lustgarten@tufts.edu

617-556-3399

Study Officials

• Michael S lustgarten, PhD

  Tufts University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Scientist II

Study Record Dates

• First Submitted: June 21, 2016
• First Posted: June 23, 2016
• Study Start: May 1, 2016
• Primary Completion: February 1, 2018
• Study Completion: November 1, 2019
• Last Updated: August 6, 2020
• Results First Posted: August 6, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)