Curcumin and Function in Older Adults (SPICE)

Does Dietary Supplementation With Curcumin Maintain or Improve Physical and Cognitive Function in Aging Adults at Increased Risk for Disability?

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.

Study Overview

• Status: Completed
• Conditions: Cognitive Function; Older Adults; Physical Function
• Intervention / Treatment: Drug: Curcumin; Drug: microcrystalline cellulose

• Study Type: Interventional
• Enrollment (Actual): 17
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• United States
  • Florida
    • Gainesville, Florida, United States, 32611
      • University of Florida

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years to 99 years (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: 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.; Other Names: Turmeric; C3 Complex
Placebo Comparator: 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.	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.; Other Names: placebo

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Florida
• Collaborators: National Institutes of Health (NIH); National Institute on Aging (NIA)
• Investigators: Principal Investigator: Stephen D Anton, PhD, University of Florida

Study record dates

Study Major Dates

• Study Start (Actual): August 11, 2017
• Primary Completion (Actual): October 18, 2019
• Study Completion (Actual): October 18, 2019

Study Registration Dates

• First Submitted: March 15, 2017
• First Submitted That Met QC Criteria: March 15, 2017
• First Posted (Actual): March 21, 2017

Study Record Updates

• Last Update Posted (Actual): July 26, 2022
• Last Update Submitted That Met QC Criteria: July 19, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: Curcumin, physical function, cognitive function
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Antineoplastic Agents; Curcumin
• Other Study ID Numbers: IRB201600334-N; P30AG028740 (U.S. NIH Grant/Contract); IRB201701371 (Other Identifier: UF Ancillary Study ID)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No