Curcumin and EGCG Supplementation to Improve Serum BDNF and Mood Disturbance

Auburn University

Status and phase: Enrolling; Early Phase 1

Conditions: Mood Disturbance

Treatments: Dietary Supplement: Epigallocatechin Gallate; Dietary Supplement: Curcumin; Other: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT06531863

AU-STUDY00000014

Details and patient eligibility

About

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)

Full 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.

Enrollment: 64 estimated patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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64 participants in 2 patient groups, including a placebo group

Curcumin and EGCG Supplementation

Experimental group

Description:

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

Treatment:

Dietary Supplement: Curcumin

Dietary Supplement: Epigallocatechin Gallate

Placebo

Placebo Comparator group

Description:

Participants will receive a placebo to consume everyday.

Treatment:

Other: Placebo