Curcumin and Function in Older Adults

Phase 2

Completed

Conditions: Older Adults
Cognitive Function
Physical Function

Interventions: Drug: microcrystalline cellulose
Drug: Curcumin

Registration Number: NCT03085680

Lead Sponsor: University of Florida

Brief Summary: This placebo-controlled RCT tests whether dietary supplementation with curcumin maintains or improves cognitive and physical function in older adults who are at high risk of functional decline due existing (mild) functional impairments and elevated biomarkers of inflammation and explore the association between functional changes and changes in biological indicators of active inflammation.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 17

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	microcrystalline cellulose	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.
Curcumin	Curcumin	Participants will be given identical capsules containing curcumin (1000 mg/day), 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.

Primary Outcome Measures

Name	Time	Method
Curcumin and Physical Function -Walking	Change in walking speed (meters/second) from Baseline and 3 months	To examine the effects of dietary supplementation with curcumin on changes in physical function walking speed- 400meter walk test.
Curcumin and Physical Function - Hand Grip	Change in grip strength (kilograms) from Baseline and 3 months	To examine the effects of dietary supplementation with curcumin on changes in physical function grip strength- hand dynamometer

Secondary Outcome Measures

Name	Time	Method
Curcumin and Cognitive Function - Attention & Memory	Change in attention from Baseline and 3 months	To examine the effects of dietary supplementation with curcumin on cognitive performance mini-mental state examination. 30 points max. The lower, the worse score.
Curcumin and Pain	Baseline and 3 months	To examine the effects of dietary supplementation with curcumin on pain symptoms (pain scale 0-10 with 10 being the worst)
Curcumin and Inflammation - Interleukin-6	From Baseline and 3 months	To examine the effects of dietary supplementation with curcumin on markers of systemic inflammation Interleukin-6 (ng/ml)