Role of the Gut Microbiome on Lean Mass and Physical Function in Older Adults
Sarcopenia
Bottom Line
View on ClinicalTrials.gov: NCT02811445 ↗Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Older Adult · 70+ yrs
- Sex
- All
- Sponsor
- Tufts University
- Primary completion
- Feb 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Whole Body Lean Mass (%WBLM) |
67.3; 61.9 | — |
| PRIMARY Physical Function Measurement |
11.2; 7.4 | — |
| PRIMARY 400-meter Gait Speed |
1.12; 0.96 | — |
| PRIMARY Leg Press 1 Repetition Maximum |
1863.9; 1343.2 | — |
Summary
Eligibility 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 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.
Data sourced from ClinicalTrials.gov (NCT02811445). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.