Intervention: Clavulanate Potassium
Trial phase: Phase 2 | Phase 3
SMILES: O=C([O-])C1C(=CCO)OC2CC(=O)N21.[K+]
Sex: All
Age groups: Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 17
Group description: Participants will be given identical capsules containing placebo (microcrystalline cellulose) and will be instructed to consume two 500 mg capsules prior to breakfast every morning with a glass of water. Participants will be instructed to follow this dosing regimen throughout the entire three-month treatment period. Compliance with the dosing regimen will be monitored both through interview and by counting capsules left at monthly clinic visits.

microcrystalline cellulose: Participants will be instructed to consume two capsules prior to breakfast every morning with a glass of water. Participants will be instructed to follow this dosing regimen throughout the entire three-month treatment period. Compliance with the dosing regimen will be monitored both through interview and by counting capsules left at monthly clinic visits.
Eligibility criteria:
Inclusion Criteria:

Age > 65 years
Usual walking speed <1 m/sec and >0.44 m/sec on the 4 m walk
Sedentary lifestyle (< 120 min per week of moderate intensity physical activity);
CRP > 1.0 mg/dL
Willingness and ability to give informed consent
Willingness to be randomized to the intervention groups
Availability for participation through duration of study

Exclusion Criteria:

Exclusion Criteria (General)

Unable to complete 400 meter walk test
Failure or inability to provide informed consent
Residence in a Skilled Nursing Facility (SNF); residence in an Assisted Living Facility (ALF) or independent housing is allowed
Self-reported inability to walk one block
Blood pressure readings >160/100
Significant cognitive impairment, defined as a known diagnosis of dementia, or a Mini-Mental State Exam (MMSE) score <24
Unable to communicate because of severe hearing loss or speech disorder
Clinically significant depression (CES-D score > 20)
Severe cardiac disease, including NYHA Class III or IV congestive heart failure, clinically significant aortic stenosis, history of cardiac arrest, use of a cardiac defibrillator, or uncontrolled angina
Severe pulmonary disease, pneumonitis or interstitial lung disease
Severe rheumatologic or orthopedic diseases (e.g., awaiting joint replacement, active inflammatory disease)
Neurological conditions that cause impaired muscle function or mobility (e.g., Parkinson's Disease, multiple sclerosis, ALS)
Other significant co-morbid medical disease (e.g. renal failure with eGFR < 30 ml/minute or on hemodialysis) or severe psychiatric disorder (e.g. bipolar, schizophrenia)
Terminal illness with life expectancy less than 12 months, as determined by a physician
Excessive alcohol use, defined as more than 5 drinks/day for males or more than 4 drinks/day for females, or more than 14 drinks per week
Current smoker or less than 3 years smoking cessation
Participating in another clinical trial or receiving an investigational product within 3 months prior to screening/enrollment

Exclusion Criteria (Curcumin-related)

Diabetes mellitus currently taking medications to lower blood glucose (oral or by injection)
Current use of anticoagulant or anti-platelet medications (aspirin 81 mg daily is allowed)
Congenital or acquired bleeding disorders
Cholelithiasis or other gall bladder or biliary tract disease
Chronic gastrointestinal blood loss or iron deficiency (serum ferritin < 12 ng/mL, with or without anemia)
History of estrogen-sensitive conditions including breast, uterine, and ovarian cancers; endometriosis; and uterine fibroids
History of Tuberculosis (TB), HIV, Hepatitis B or C, or other disease potentially compromising immune function
Current use of medications targeting immune or inflammatory function (e.g., sulfasalazine)
Current use of anabolic medications (i.e., growth hormones or testosterone), antidepressant medications and antipsychotic agents (including monoamine oxidase inhibitors), or anticholinesterase inhibitors (i.e., Aricept)

Temporary Exclusion Criteria

Acute infection (urinary, respiratory, other) or hospitalization within 1 month
Myocardial infarction, CABG, or valve replacement within past 6 months
Pulmonary embolism or deep venous thrombosis within past 6 months
Stroke, hip fracture, hip or knee replacement, or spinal surgery within past 4 months
Receiving physical therapy for gait, balance, or other lower extremity training