Clinical trial NCT06531863: Curcumin and EGCG Supplementation to Improve Serum BDNF and Mood Disturbance
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: EARLY_PHASE1
Conditions: Mood Disturbance
Lead sponsor: Auburn University
Sponsor class: OTHER
First posted: 2024-08-01
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Intervention Group (supplementation with 1330mg/day curcumin and 350mg/day EGCG)
Primary purpose: TREATMENT

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)

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.

Eligibility criteria: 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

Primary outcomes:
measure: Changes in total distress as measured via DASS-21 total score.
timeFrame: 8-weeks
measure: Changes in serum brain derived neurotrophic factor (BDNF).
timeFrame: 8-weeks
Secondary outcomes:
measure: Changes in DASS-21 subscales (depression, anxiety, stress).
timeFrame: 8-weeks
measure: Changes in subjective sleep quality.
timeFrame: 8-weeks
measure: Changes in subjective physical activity.
timeFrame: 8-weeks
measure: Changes in diet quality.
timeFrame: 8-weeks
measure: Number of Participants who report daily adherence to supplementation intake
timeFrame: 8-weeks
measure: Changes in fasting alanine aminotransferase (ALT)
timeFrame: 8-weeks
measure: Changes in fasting aspartate aminotransferase (AST)
timeFrame: 8-weeks
Other outcomes:
Locations:
city: Auburn
country: United States
facility: Auburn University School of Kinesiology
state: Alabama
Study officials:
affiliation: Auburn University
name: Andrew D Fruge, PhD
role: PRINCIPAL_INVESTIGATOR
References: