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Trial record 15 of 158 for:    Enzyme | curcumin

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 : May 29, 2019
Sponsor:
Collaborators:
National Institute on Aging (NIA)
National Institutes of Health (NIH)
Information provided by (Responsible Party):
University of Florida

Tracking Information
First Submitted Date  ICMJE March 15, 2017
First Posted Date  ICMJE March 21, 2017
Last Update Posted Date May 29, 2019
Actual Study Start Date  ICMJE August 11, 2017
Estimated Primary Completion Date July 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 15, 2017)
  • 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.
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03085680 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 15, 2017)
  • 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.
  • 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)
  • 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)
  • 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)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Curcumin and Function in Older Adults
Official Title  ICMJE Does Dietary Supplementation With Curcumin Maintain or Improve Physical and Cognitive Function in Aging Adults at Increased Risk for Disability?
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Randomized placebo-controlled design.
Masking: Double (Participant, Investigator)
Masking Description:
Double-blinded
Primary Purpose: Prevention
Condition  ICMJE
  • Older Adults
  • Physical Function
  • Cognitive Function
Intervention  ICMJE
  • 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
  • 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
Study Arms  ICMJE
  • 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.
    Intervention: Drug: Curcumin
  • 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.
    Intervention: Drug: microcrystalline cellulose
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 15, 2017)
24
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2020
Estimated Primary Completion Date July 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 65 Years to 99 Years   (Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Robert T Mankowski, PhD 3522945055 r.mankowski@ufl.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03085680
Other Study ID Numbers  ICMJE IRB201600334-N
P30AG028740 ( U.S. NIH Grant/Contract )
IRB201701371 ( Other Identifier: UF Ancillary Study ID )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party University of Florida
Study Sponsor  ICMJE University of Florida
Collaborators  ICMJE
  • National Institute on Aging (NIA)
  • National Institutes of Health (NIH)
Investigators  ICMJE
Principal Investigator: Stephen D Anton, PhD University of Florida
PRS Account University of Florida
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP