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Trial record 1 of 162 for:    curcumin
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Curcumin and Function in Older Adults (SPICE)

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ClinicalTrials.gov Identifier: NCT03085680
Recruitment Status : Recruiting
First Posted : March 21, 2017
Last Update Posted : September 28, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Older Adults Physical Function Cognitive Function Drug: Curcumin Drug: microcrystalline cellulose Phase 2 Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized placebo-controlled design.
Masking: Double (Participant, Investigator)
Masking Description: Double-blinded
Primary Purpose: Prevention
Official Title: Does Dietary Supplementation With Curcumin Maintain or Improve Physical and Cognitive Function in Aging Adults at Increased Risk for Disability?
Actual Study Start Date : August 11, 2017
Estimated Primary Completion Date : July 1, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Health Checkup
U.S. FDA Resources

Arms and Interventions

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 Name: placebo


Outcome Measures

Primary Outcome Measures :
  1. Curcumin and physical function -Walking [ Time Frame: Change in walking speed (seconds) from Baseline and 3 months ]
    To examine the effects of dietary supplementation with curcumin on changes in physical function walking speed- 400meter walk test.

  2. Curcumin and physical function - Hand grip [ Time Frame: 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 :
  1. Curcumin and cognitive function - Attention & Memory [ Time Frame: 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.

  2. Curcumin and Pain [ Time Frame: Change pain level from Baseline and 3 months ]
    To examine the effects of dietary supplementation with curcumin on pain symptoms (pain scale 1-5 with 5 being the worst)

  3. Curcumin and inflammation - interleukin-2 [ Time Frame: Change in inflammatory biomarker concentration in blood from Baseline and 3 months ]
    To examine the effects of dietary supplementation with curcumin on markers of systemic inflammation interleukin-2 (ng/ml)

  4. Curcumin and inflammation - C-reactive protein [ Time Frame: Change in inflammatory biomarker concentration in blood from Baseline and 3 months ]
    To examine the effects of dietary supplementation with curcumin on markers of systemic inflammation C-reactive protein (ng/ml)


Eligibility Criteria

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Ages Eligible for Study:   70 Years to 99 Years   (Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age > 70 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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03085680


Contacts
Contact: Robert T Mankowski, PhD 3522945055 r.mankowski@ufl.edu

Locations
United States, Florida
University of Florida Recruiting
Gainesville, Florida, United States, 32611
Principal Investigator: Stephen D Anton, PhD         
Principal Investigator: Robert T Mankowski, PhD         
Sponsors and Collaborators
University of Florida
National Institute on Aging (NIA)
Investigators
Principal Investigator: Stephen D Anton, PhD University of Florida
More Information

Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT03085680     History of Changes
Other Study ID Numbers: IRB201600334
P30AG028740 ( U.S. NIH Grant/Contract )
First Posted: March 21, 2017    Key Record Dates
Last Update Posted: September 28, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Florida:
Curcumin, physical function, cognitive function

Additional relevant MeSH terms:
Curcumin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action