Last reviewed · How we verify

NCT03085680: SPICE

Curcumin and Function in Older Adults

Completed Phase 2, PHASE3 Results posted Last updated 26 July 2022
What this trial tests

Phase 2, PHASE3 trial testing Curcumin in Older Adults in 17 participants. Completed in 18 October 2019.

Timeline
11 August 2017
Primary endpoint
18 October 2019
18 October 2019

Quick facts

Lead sponsorUniversity of Florida
PhasePhase 2, PHASE3
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingdouble
Primary purposeprevention
Enrollment17
Start date11 August 2017
Primary completion18 October 2019
Estimated completion18 October 2019
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

University of Florida

Who can join

Adults 65 to 99, any sex, with Older Adults or Physical Function. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Curcumin and Physical Function -Walking Primary · 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.

GroupValue95% CI
Curcumin0.014± 0.090
Placebo0.103± 0.10
Curcumin and Physical Function - Hand Grip Primary · 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

GroupValue95% CI
Curcumin0.63± 4.90
Placebo-0.25± 3.14
Curcumin and Cognitive Function - Attention & Memory Secondary · 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.

GroupValue95% CI
Curcumin0.33± 3.94
Placebo-2.75± 5.09
Curcumin and Pain Secondary · 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)

Baseline
GroupValue95% CI
Curcumin0.97± 1.3
Placebo1.3± 1.7
90 Days
GroupValue95% CI
Curcumin0.2± 0.4
Placebo1.6± 1.7
Curcumin and Inflammation - Interleukin-6 Secondary · From Baseline and 3 months

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

Baseline
GroupValue95% CI
Curcumin3.1± 1.4
Placebo2.7± 1.7
90 Days
GroupValue95% CI
Curcumin3.4± 1.5
Placebo3.6± 1.5

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Chronic curcumin treatment improves spatial working memory but not recognition memory in middle-aged rhesus monkeys.
    Moore TL, Bowley B, Shultz P, Calderazzo S, et al · · 2017 · cited 32× · PMID 29047012 · DOI 10.1007/s11357-017-9998-2
  2. The Molecular Mechanism of Polyphenols in the Regulation of Ageing Hallmarks.
    Pereira QC, Dos Santos TW, Fortunato IM, Ribeiro ML. · · 2023 · cited 31× · PMID 36982583 · DOI 10.3390/ijms24065508
  3. Nutritional senolytics and senomorphics: Implications to immune cells metabolism and aging - from theory to practice.
    Luís C, Maduro AT, Pereira P, Mendes JJ, et al · · 2022 · cited 29× · PMID 36159455 · DOI 10.3389/fnut.2022.958563
  4. Reconnoitering the Therapeutic Role of Curcumin in Disease Prevention and Treatment: Lessons Learnt and Future Directions.
    Sivani BM, Azzeh M, Patnaik R, Pantea Stoian A, et al · · 2022 · cited 26× · PMID 35888763 · DOI 10.3390/metabo12070639
  5. Clinical Insights on Caloric Restriction Mimetics for Mitigating Brain Aging and Related Neurodegeneration.
    Trisal A, Singh AK. · · 2024 · cited 9× · PMID 39412683 · DOI 10.1007/s10571-024-01493-2
  6. Mitophagy-promoting agents and their ability to promote healthy-aging.
    Srivastava V, Gross E. · · 2023 · cited 9× · PMID 37650304 · DOI 10.1042/bst20221363
  7. New Trends in Aging Drug Discovery.
    Benhamú B, Martín-Fontecha M, Vázquez-Villa H, López-Rodríguez ML, et al · · 2022 · cited 6× · PMID 36009552 · DOI 10.3390/biomedicines10082006
  8. Induction of Cardiac Pathology: Endogenous versus Exogenous Nrf2 Upregulation.
    Mathis BJ, Kato H, Hiramatsu Y. · · 2022 · cited 5× · PMID 36497112 · DOI 10.3390/cells11233855

Verify or expand the search:

Other trials of Curcumin

Trials testing the same drug.

Other recruiting trials for Older Adults

Currently open trials in the same condition.

Other University of Florida trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03085680.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing