Cognitive Function, Older Adults, Physical Function
Conditions
Keywords
Curcumin, physical function, cognitive function
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.
Interventions
DRUGCurcumin
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.
DRUGmicrocrystalline 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.
Sponsors
National Institute on Aging (NIA)
National Institutes of Health (NIH)
University of Florida
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Masking description
Double-blinded
Intervention model description
Randomized placebo-controlled design.
Eligibility
Sex/Gender
ALL
Age
65 Years to 99 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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) |
| 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) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 9 |
| 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. | 8 |
| Total | 17 |
Baseline characteristics
| Characteristic | Placebo | Total | Curcumin |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 8 Participants | 17 Participants | 9 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 76.2 Years STANDARD_DEVIATION 5.6 | 77.8 Years STANDARD_DEVIATION 7.85 | 79.4 Years STANDARD_DEVIATION 10.1 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 8 Participants | 17 Participants | 9 Participants |
| Region of Enrollment United States | 8 participants | 17 participants | 9 participants |
| Sex: Female, Male Female | 4 Participants | 8 Participants | 4 Participants |
| Sex: Female, Male Male | 4 Participants | 9 Participants | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 9 | 0 / 8 |
| other Total, other adverse events | 0 / 9 | 0 / 8 |
| serious Total, serious adverse events | 0 / 9 | 0 / 8 |
Outcome results
Primary
Curcumin and Physical Function - Hand Grip
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Curcumin | Curcumin and Physical Function - Hand Grip | 0.63 Kilograms | Standard Deviation 4.9 |
| Placebo | Curcumin and Physical Function - Hand Grip | -0.25 Kilograms | Standard Deviation 3.14 |
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.
Time frame: Change in walking speed (meters/second) from Baseline and 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Curcumin | Curcumin and Physical Function -Walking | 0.014 meters/second | Standard Deviation 0.09 |
| Placebo | Curcumin and Physical Function -Walking | 0.103 meters/second | Standard Deviation 0.1 |
Secondary
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.
Time frame: Change in attention from Baseline and 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Curcumin | Curcumin and Cognitive Function - Attention & Memory | 0.33 units on a scale | Standard Deviation 3.94 |
| Placebo | Curcumin and Cognitive Function - Attention & Memory | -2.75 units on a scale | Standard Deviation 5.09 |
Secondary
Curcumin and Inflammation - Interleukin-6
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Curcumin | Curcumin and Inflammation - Interleukin-6 | Baseline | 3.1 (ng/ml) | Standard Deviation 1.4 |
| Curcumin | Curcumin and Inflammation - Interleukin-6 | 90 Days | 3.4 (ng/ml) | Standard Deviation 1.5 |
| Placebo | Curcumin and Inflammation - Interleukin-6 | Baseline | 2.7 (ng/ml) | Standard Deviation 1.7 |
| Placebo | Curcumin and Inflammation - Interleukin-6 | 90 Days | 3.6 (ng/ml) | Standard Deviation 1.5 |
Secondary
Curcumin and Pain
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Curcumin | Curcumin and Pain | Baseline | 0.97 score on a scale | Standard Deviation 1.3 |
| Curcumin | Curcumin and Pain | 90 Days | 0.2 score on a scale | Standard Deviation 0.4 |
| Placebo | Curcumin and Pain | Baseline | 1.3 score on a scale | Standard Deviation 1.7 |
| Placebo | Curcumin and Pain | 90 Days | 1.6 score on a scale | Standard Deviation 1.7 |