Curcumin and Function in Older Adults | NCT03085680

NCT03085680

Protocol Section

Identification Module

Results Section

Participant Flow Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module

ID	Type	Description	Link
P30AG028740	U.S. NIH Grant/Contract		View source
IRB201701371	Other Identifier	UF Ancillary Study ID

Status Module

Name	Class
National Institute on Aging (NIA)	NIH
National Institutes of Health (NIH)	NIH

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Curcumin	Experimental	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
Placebo	Placebo Comparator	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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Curcumin	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.

Outcomes Module

Primary Outcomes

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 Outcomes

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

Eligibility Module

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

Name	Affiliation	Role
Stephen D Anton, PhD	University of Florida	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
University of Florida		Gainesville	Florida	32611	United States

Arm/Group Information

ID	Title	Description
FG000	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. 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.
FG001	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. 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.

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	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. 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.

Units	Counts
Participants	BG000

Baseline Measures

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Categorical			Count of Participants

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Curcumin and Physical Function -Walking

To examine the effects of dietary supplementation with curcumin on changes in physical function walking speed- 400meter walk test.

Posted

Mean

Standard Deviation

meters/second

Change in walking speed (meters/second) from Baseline and 3 months

ID	Title	Description
OG000	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. 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.

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	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. 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.

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Mar 17, 2016	Nov 4, 2021	Prot_SAP_000.pdf
ICF	No	No	Yes	Informed Consent Form	Mar 6, 2019	Nov 4, 2021	ICF_001.pdf

ID	Term
D036381	Diarylheptanoids
D006536	Heptanes
D000473	Alkanes
D006839	Hydrocarbons, Acyclic