Trials / Recruiting
RecruitingNCT06531863
Curcumin and EGCG Supplementation to Improve Serum BDNF and Mood Disturbance
A Randomized Controlled Trial to Determine the Effects of Curcumin and Epigallocatechin Gallate Supplementation on Serum Brain Derived Neurotrophic Factor and Mood Disturbance in Adults
- Status
- Recruiting
- Phase
- EARLY_Phase 1
- Study type
- Interventional
- Enrollment
- 64 (estimated)
- Sponsor
- Auburn University · Academic / Other
- Sex
- All
- Age
- 18 Years – 50 Years
- Healthy volunteers
- Accepted
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)
Detailed description
Clinical assessments will include phlebotomy (completed at weeks 0 and 8) and questionnaires which will be completed at weeks 0, 4, and 8 to assess changes in mood disorder symptomology and serum BDNF. 3 days of 24-hour diet recalls will be collected at weeks 0, 4 and 8. Daily reminders via Emitrr will be sent daily to ensure adherence to supplementation. This is an 8-week randomized placebo controlled trial looking at mood disturbance and serum BDNF in moderately depressed adults aged 18-50. Participants will be randomized into the intervention group or placebo with the intervention group consuming 1,330mg/day curcumin and 350mg/day EGCG. Baseline mood disturbance questionnaires (DASS-21, GAD-7, GSAQ, IPAQ) and serum BDNF will be taken prior to intervention and again after intervention.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIETARY_SUPPLEMENT | Curcumin | 1,330 mg curcumin |
| DIETARY_SUPPLEMENT | Epigallocatechin Gallate | 350 mg Epigallocatechin gallate (EGCG) |
| OTHER | Placebo | Placebo to be consumed after randomization. |
Timeline
- Start date
- 2024-09-30
- Primary completion
- 2025-05-01
- Completion
- 2025-08-01
- First posted
- 2024-08-01
- Last updated
- 2025-02-14
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT06531863. Inclusion in this directory is not an endorsement.