Older AdultsPhase 2/3SPICENCT03085680
Curcumin and Function in Older Adults
A Phase 2/3 study testing Curcumin and microcrystalline cellulose in people with Older Adults and Physical Function, run by University of Florida at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 65 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Older Adults, Physical Function, Cognitive Function
- What is being tested?
- Curcumin and microcrystalline cellulose
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Aug 2017to 18 Oct 2019
- Phase
- Phase 2/3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 99 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 32Show fewer
- 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
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Does Dietary Supplementation With Curcumin Maintain or Improve Physical and Cognitive Function in Aging Adults at Increased Risk for Disability?
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.
- Conditions
- Older Adults, Physical Function, Cognitive Function
- Being tested
- Curcumin, microcrystalline cellulose
- Keywords
- Curcumin, physical function, cognitive function
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CurcuminDrug
Also called Turmeric, C3 Complex
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.
microcrystalline celluloseDrug
Also called placebo
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: microcrystalline cellulose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Curcumin and Physical Function -Walking
To examine the effects of dietary supplementation with curcumin on changes in physical function walking speed- 400meter walk test.
Measured: 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
Measured: Change in grip strength (kilograms) from Baseline and 3 months
Secondary outcomes (3)
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.
Measured: Change in attention from Baseline and 3 months
Curcumin and Pain
To examine the effects of dietary supplementation with curcumin on pain symptoms (pain scale 0-10 with 10 being the worst)
Measured: Baseline and 3 months
Curcumin and Inflammation - Interleukin-6
To examine the effects of dietary supplementation with curcumin on markers of systemic inflammation Interleukin-6 (ng/ml)
Measured: From Baseline and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2017
- Study start11 Aug 2017
- Primary completion18 Oct 2019
- Study completion18 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Older AdultsStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized placebo-controlled design.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA), National Institutes of Health (NIH)
- Responsible party
- Sponsor
- Investigators
- Stephen D Anton, PhD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03085680
- Sponsor's protocol ID
- IRB201600334-N
- Other IDs
- P30AG028740, IRB201701371
- Acronym
- SPICE
- Status last verified
- Jul 2022
- First submitted
- 15 Mar 2017
- Last updated
- 26 Jul 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Dietary Supplementation With Curcumin Maintain or Improve Physical and Cognitive Function in Aging Adults at Increased Risk for Disability?
- ClinicalTrials.gov ID
- NCT03085680
- Acronym / sponsor ID
- SPICE / IRB201600334-N
- Conditions
- Older Adults, Physical Function, Cognitive Function
- Keywords
- Curcumin, physical function, cognitive function
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA), National Institutes of Health (NIH)
- Study start
- 11 Aug 2017 (actual)
- Primary completion
- 18 Oct 2019 (actual)
- Study completion
- 18 Oct 2019 (actual)
- First posted
- 21 Mar 2017 (actual)
- Results
- Posted 2 Feb 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Randomized placebo-controlled design.
| Arm | Type | Receives |
|---|---|---|
| Curcumin | Experimental | Drug: CurcuminParticipants 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. |
| Placebo | Placebo comparator | Drug: microcrystalline celluloseParticipants 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. |
Who may qualify
- Ages
- 65 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (32 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CurcuminAlso: Turmeric, C3 ComplexParticipants 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. | Drug | Curcumin |
| microcrystalline celluloseAlso: placeboParticipants 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. | Drug | Placebo |
Primary outcome
Curcumin and Physical Function -Walking
Time frame: 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
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
3 secondary outcomes
Curcumin and Cognitive Function - Attention & Memory
Time frame: Change in attention from Baseline and 3 months
Curcumin and Pain
Time frame: Baseline and 3 months
Curcumin and Inflammation - Interleukin-6
Time frame: From Baseline and 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephen D Anton, PhD principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Curcumin and microcrystalline cellulose in people with Older Adults and Physical Function, run by University of Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Feb 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Curcumin and Physical Function -Walking (time frame: Change in walking speed (meters/second) from Baseline and 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2022.