Curcumin and EGCG Supplementation to Improve Serum BDNF and Mood Disturbance

NCT06531863 | Recruiting Early Phase 1

• 1 other identifier: AU-STUDY00000014
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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)

Conditions

Mood Disturbance

Outcome Measures

Primary Outcomes (2)

• Changes in total distress as measured via DASS-21 total score.

  The DASS-21 (Depression Anxiety and Stress Scale) Total ranges from 0 to 63, with lower numbers indicating less distress

  8-weeks

• Changes in serum brain derived neurotrophic factor (BDNF).

  Serum BDNF will be measured via commercial ELISA kits. Higher levels of serum BDNF are optimal.

  8-weeks

Secondary Outcomes (7)

• Changes in DASS-21 subscales (depression, anxiety, stress).

  8-weeks

• Changes in subjective sleep quality.

  8-weeks

• Changes in subjective physical activity.

  8-weeks

• Changes in diet quality.

  8-weeks

• Number of Participants who report daily adherence to supplementation intake

  8-weeks

Study Arms (2)

Curcumin and EGCG Supplementation

EXPERIMENTAL

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

Dietary Supplement: Curcumin; Dietary Supplement: Epigallocatechin Gallate

Placebo

PLACEBO COMPARATOR

Participants will receive a placebo to consume everyday.

Other: Placebo

Interventions

Curcumin DIETARY_SUPPLEMENT

1,330 mg curcumin

Curcumin and EGCG Supplementation

Epigallocatechin Gallate DIETARY_SUPPLEMENT

350 mg Epigallocatechin gallate (EGCG)

Also known as: EGCG

Curcumin and EGCG Supplementation

Placebo OTHER

Placebo to be consumed after randomization.

Placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Currently consume curcumin or green tea daily
• Currently, pregnant, nursing, or trying to become pregnant
• Currently diagnosed with a perimenopausal disorder

Sponsors & Collaborators

• Auburn University: lead

Study Sites (1)

Auburn University School of Kinesiology

Auburn, Alabama, 36849, United States

RECRUITING

MeSH Terms

Interventions

Curcumin; epigallocatechin gallate

Intervention Hierarchy (Ancestors)

Diarylheptanoids; Heptanes; Alkanes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic

Study Officials

• Andrew D Fruge, PhD

  Auburn University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Aidan Cavanah, MSc

CONTACT

2057893258; amc0108@auburn.edu

Andrew Fruge, PhD

CONTACT

adf0003@auburn.edu

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: This is a double-blinded study with masking of participants and investigator using computer generated allocation sequences and sealed treatment and placebo supplement bags.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Graduate Assistant

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

Study Record Dates

• First Submitted: July 16, 2024
• First Posted: August 1, 2024
• Study Start: September 30, 2024
• Primary Completion: May 1, 2025
• Study Completion: August 1, 2025
• Last Updated: February 14, 2025

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)