Curcumin and Function in Older Adults

NCT ID: NCT03085680

Last Updated: 2022-07-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 17 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-08-11
• Study Completion Date: 2019-10-18

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.

Conditions

Older Adults; Physical Function; Cognitive Function

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Curcumin

Intervention Type: DRUG

Participants will be given 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.

Placebo

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.

Group Type: PLACEBO_COMPARATOR

microcrystalline cellulose

Intervention Type: DRUG

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.

Interventions

Curcumin

Participants will be given 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.

Intervention Type: DRUG

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.

Intervention Type: DRUG

Other Intervention Names

Turmeric; C3 Complex; placebo

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

• 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

• 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)

• 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

• Minimum Eligible Age: 65 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute on Aging (NIA)

NIH

Sponsor Role: collaborator

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

University of Florida

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Stephen D Anton, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Locations

University of Florida

Gainesville, Florida, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

P30AG028740

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB201701371

Identifier Type: OTHER

Identifier Source: secondary_id

IRB201600334-N

Identifier Type: -

Identifier Source: org_study_id