Clinical trial NCT03085680: Curcumin and Function in Older Adults
Official title: Does Dietary Supplementation With Curcumin Maintain or Improve Physical and Cognitive Function in Aging Adults at Increased Risk for Disability?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Older Adults
Physical Function
Cognitive Function
Keywords: Curcumin, physical function, cognitive function
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
name: National Institutes of Health (NIH)
First posted: 2017-03-21
Enrollment: 17
Sex: ALL
Minimum age (years): 65
Maximum age (years): 99
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized placebo-controlled design.
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Curcumin and Physical Function -Walking
timeFrame: Change in walking speed (meters/second) from Baseline and 3 months
measure: Curcumin and Physical Function - Hand Grip
timeFrame: Change in grip strength (kilograms) from Baseline and 3 months
Secondary outcomes:
measure: Curcumin and Cognitive Function - Attention & Memory
timeFrame: Change in attention from Baseline and 3 months
measure: Curcumin and Pain
timeFrame: Baseline and 3 months
measure: Curcumin and Inflammation - Interleukin-6
timeFrame: From Baseline and 3 months
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida
state: Florida
Study officials:
affiliation: University of Florida
name: Stephen D Anton, PhD
role: PRINCIPAL_INVESTIGATOR
References: