Recruiting
Early Phase 1

Curcumin & EGCG

Sponsor:

Auburn University

Code:

NCT06531863

Conditions

Mood Disturbance

Eligibility Criteria

Sex: All

Age: 18 - 50

Healthy Volunteers: Accepted

Interventions

Curcumin

Epigallocatechin Gallate

Placebo

Study Details

Brief summary:

The goal of this randomized placebo controlled trial is to examine mood disturbance and serum brain derived neurotrophic factor (BDNF) in people (age 18-50) with DASS-21 subscale scores >9. The main questions it aims to answer are:

Does curcumin and EGCG supplementation improve mood disturbance symptomology? Does curcumin and EGCG supplementation increase serum BDNF? Researchers will compare intervention versus placebo.

Participants will consume an 8-week supplement of both:

  • 1,330mg/day curcumin
  • 350mg/day epigallocatechin gallate (EGCG)

Conditions

Mood Disturbance

Study ID

NCT06531863

Start date

Sep 30, 2024

Status verified date

Oct, 2024

Completion date

Aug 1, 2025

Anticipated

Primary completion date

May 1, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 50

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Adults age 18-50
  • Depression subscale score of >9/21 on the DASS-21
  • No change in medications or supplements over the past 3 months
  • Can read and speak English

Exclusion Criteria:

  • Currently consume curcumin or green tea daily
  • Currently, pregnant, nursing, or trying to become pregnant
  • Currently diagnosed with a perimenopausal disorder

Study Design

Enrollment

64 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Curcumin and EGCG Supplementation

Participants in the intervention group with consume 1,330mg/day curcumin with 350mg/day EGCG.

placebo comparator: Placebo

Participants will receive a placebo to consume everyday.

Interventions

Curcumin

1,330 mg curcumin

Epigallocatechin Gallate

350 mg Epigallocatechin gallate (EGCG)

Placebo

Placebo to be consumed after randomization.

Primary outcome measure

  • Changes in total distress as measured via DASS-21 total score. [ Time Frame: 8-weeks ]
  • Changes in serum brain derived neurotrophic factor (BDNF). [ Time Frame: 8-weeks ]

Central Contacts and Locations

Central contacts

Andrew Fruge, PhD

adf0003@auburn.edu

Locations

Auburn University School of Kinesiology

Recruiting

Auburn, Alabama, United States, 36849

Contacts

More Information

Sponsor

Auburn University

Last update posted

Feb 14, 2025

Last verified

Oct, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Auburn University on 2025-02-14.