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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

TypeNameDescription
DIETARY_SUPPLEMENTCurcumin1,330 mg curcumin
DIETARY_SUPPLEMENTEpigallocatechin Gallate350 mg Epigallocatechin gallate (EGCG)
OTHERPlaceboPlacebo 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.