Curcumin and EGCG Supplementation to Improve Serum BDNF and Mood Disturbance

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

EARLY_PHASE1

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-30

Study Completion Date

2025-08-01

Brief Summary

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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)

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Detailed Description

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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

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Mood Disturbance

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Intervention Group (supplementation with 1330mg/day curcumin and 350mg/day EGCG)

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

This is a double-blinded study with masking of participants and investigator using computer generated allocation sequences and sealed treatment and placebo supplement bags.

Study Groups

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Curcumin and EGCG Supplementation

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

Group Type EXPERIMENTAL

Curcumin

Intervention Type DIETARY_SUPPLEMENT

1,330 mg curcumin

Epigallocatechin Gallate

Intervention Type DIETARY_SUPPLEMENT

350 mg Epigallocatechin gallate (EGCG)

Placebo

Participants will receive a placebo to consume everyday.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Placebo to be consumed after randomization.

Interventions

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Curcumin

1,330 mg curcumin

Intervention Type DIETARY_SUPPLEMENT

Epigallocatechin Gallate

350 mg Epigallocatechin gallate (EGCG)

Intervention Type DIETARY_SUPPLEMENT

Placebo

Placebo to be consumed after randomization.

Intervention Type OTHER

Other Intervention Names

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EGCG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes