SPICE: Curcumin and Function in Older Adults

• Sponsor: University of Florida (Other)
• Overall Status: Completed
• CT.gov ID: NCT03085680
• Collaborator: National Institute on Aging (NIA) (NIH), National Institutes of Health (NIH) (NIH)
• Enrollment: 17
• Location: 1
• Arms: 2
• Actual Duration (Months): 26.2
• Patients Per Site Per Month: 0.6

Study Details

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
• Actual Enrollment: 17 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Randomized placebo-controlled design.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: Aug 11, 2017
• Actual Primary Completion Date: Oct 18, 2019
• Actual Study Completion Date: Oct 18, 2019

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 Names: placebo

Outcome Measures

Primary Outcome Measures

1. Curcumin and Physical Function -Walking [Change in walking speed (meters/second) 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 [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 [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 [Baseline and 3 months]

   To examine the effects of dietary supplementation with curcumin on pain symptoms (pain scale 0-10 with 10 being the worst)

3. Curcumin and Inflammation - Interleukin-6 [From Baseline and 3 months]

   To examine the effects of dietary supplementation with curcumin on markers of systemic inflammation Interleukin-6 (ng/ml)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 65 Years to 99 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Florida	Gainesville	Florida	United States	32611

Sponsors and Collaborators

• University of Florida
• National Institute on Aging (NIA)
• National Institutes of Health (NIH)

Investigators

• Principal Investigator: Stephen D Anton, PhD, University of Florida

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Mar 17, 2016
• Informed Consent Form - Mar 6, 2019

More Information

Publications

None provided.

• Responsible Party: University of Florida
• ClinicalTrials.gov Identifier: NCT03085680
• Other Study ID Numbers: IRB201600334-N; P30AG028740; IRB201701371
• First Posted: Mar 21, 2017
• Last Update Posted: Jul 26, 2022
• Last Verified: Jul 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: Yes
• 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

Study Results

Participant Flow

Arm/Group Title	Curcumin	Placebo
Arm/Group Description	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.	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.
Period Title: Overall Study
STARTED	9	8
COMPLETED	9	8
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Curcumin	Placebo	Total
Arm/Group Description	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.	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.	Total of all reporting groups
Overall Participants	9	8	17
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	0 0%	0 0%	0 0%
>=65 years	9 100%	8 100%	17 100%
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	79.4 (10.1)	76.2 (5.6)	77.8 (7.85)
Sex: Female, Male (Count of Participants)
Female	4 44.4%	4 50%	8 47.1%
Male	5 55.6%	4 50%	9 52.9%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	0 0%	0 0%	0 0%
White	9 100%	8 100%	17 100%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
United States	9 100%	8 100%	17 100%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Curcumin	Placebo
Arm/Group Description	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.	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.
Measure Participants	9	8
Mean (Standard Deviation) [meters/second]	0.014 (0.090)	0.103 (0.10)

2. Primary Outcome

Title	Curcumin and Physical Function - Hand Grip
Description	To examine the effects of dietary supplementation with curcumin on changes in physical function grip strength- hand dynamometer
Time Frame	Change in grip strength (kilograms) from Baseline and 3 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Curcumin	Placebo
Arm/Group Description	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.	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.
Measure Participants	9	8
Mean (Standard Deviation) [Kilograms]	0.63 (4.90)	-0.25 (3.14)

3. Secondary Outcome

Title	Curcumin and Cognitive Function - Attention & Memory
Description	To examine the effects of dietary supplementation with curcumin on cognitive performance mini-mental state examination. 30 points max. The lower, the worse score.
Time Frame	Change in attention from Baseline and 3 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Curcumin	Placebo
Arm/Group Description	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.	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.
Measure Participants	9	8
Mean (Standard Deviation) [units on a scale]	0.33 (3.94)	-2.75 (5.09)

4. Secondary Outcome

Title	Curcumin and Pain
Description	To examine the effects of dietary supplementation with curcumin on pain symptoms (pain scale 0-10 with 10 being the worst)
Time Frame	Baseline and 3 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Curcumin	Placebo
Arm/Group Description	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.	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.
Measure Participants	9	8
Baseline	0.97 (1.3)	1.3 (1.7)
90 Days	0.2 (0.4)	1.6 (1.7)

5. Secondary Outcome

Title	Curcumin and Inflammation - Interleukin-6
Description	To examine the effects of dietary supplementation with curcumin on markers of systemic inflammation Interleukin-6 (ng/ml)
Time Frame	From Baseline and 3 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Curcumin	Placebo
Arm/Group Description	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.	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.
Measure Participants	9	8
Baseline	3.1 (1.4)	2.7 (1.7)
90 Days	3.4 (1.5)	3.6 (1.5)

Adverse Events

Time Frame	The adverse events were collected over the whole duration of the study for each participant. In particular, each participant underwent a 12-week study period, during which we monitored for adverse events and noted, if any.
Arm/Group Title	Curcumin		Placebo
Arm/Group Description	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.		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.
All Cause Mortality
	Curcumin		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/9 (0%)		0/8 (0%)
Serious Adverse Events
	Curcumin		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/9 (0%)		0/8 (0%)
Other (Not Including Serious) Adverse Events
	Curcumin		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/9 (0%)		0/8 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.