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

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)

Study Overview

• Status: Recruiting
• Conditions: Mood Disturbance
• Intervention / Treatment: Other: Placebo; Dietary supplement: Curcumin; Dietary supplement: Epigallocatechin Gallate

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.

• Study Type: Interventional
• Enrollment (Estimated): 64
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Aidan Cavanah, MSc; Phone Number: 2057893258; Email: amc0108@auburn.edu
• Study Contact Backup: Name: Andrew Fruge, PhD; Email: adf0003@auburn.edu

Study Locations

• United States
  • Alabama
    • Auburn, Alabama, United States, 36849
      • Recruiting
      • Auburn University School of Kinesiology
      • Contact: Drew Fruge, PhD; Phone Number: 3448448433; Email: adf0003@auburn.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Participants will receive a placebo to consume everyday.	Other: Placebo; Placebo to be consumed after randomization.
Experimental: Curcumin and EGCG Supplementation; Participants in the intervention group with consume 1,330mg/day curcumin with 350mg/day EGCG.	Dietary supplement: Curcumin; 1,330 mg curcumin; Dietary supplement: Epigallocatechin Gallate; 350 mg Epigallocatechin gallate (EGCG); Other Names: EGCG

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in DASS-21 subscales (depression, anxiety, stress).	The DASS-21 (Depression Anxiety and Stress Scale) subscales include Depression, Anxiety, and Stress, which range from 0 to 21, with lower numbers indicating less distress	8-weeks
Changes in subjective sleep quality.	Using Global Sleep Assessment Questionnaire includes 11 questions outlined with "During the PAST 4 WEEKS, how often" with answer choices ranging from "never, sometimes, usually and always"	8-weeks
Changes in subjective physical activity.	Using International Physical Activity Questionnaire has 27 questions that span 5 activity domains from "job related physical activity, transportation physical activity, house work and maintenance, recreation and sport as well as time spent sitting" over the past 7-days.	8-weeks
Changes in diet quality.	Using diet recalls over the past 24 hours.	8-weeks
Number of Participants who report daily adherence to supplementation intake	Number of participants that report consuming supplement >80% of days via daily text messages	8-weeks
Changes in fasting alanine aminotransferase (ALT)	Phlebotomy will be obtained while fasted 8+ hours and alanine aminotransferase (ALT) will be measured as part of a comprehensive metabolic panel and reported in mg/dl. Lower concentrations are optimal.	8-weeks
Changes in fasting aspartate aminotransferase (AST)	Phlebotomy will be obtained while fasted 8+ hours and aspartate transferase (AST) will be measured as part of a comprehensive metabolic panel and reported in mg/dl. Lower concentrations are optimal.	8-weeks

Collaborators and Investigators

• Sponsor: Auburn University
• Investigators: Principal Investigator: Andrew D Frugé, PhD, Auburn University

Study record dates

Study Major Dates

• Study Start (Actual): September 30, 2024
• Primary Completion (Estimated): May 1, 2025
• Study Completion (Estimated): August 1, 2025

Study Registration Dates

• First Submitted: July 16, 2024
• First Submitted That Met QC Criteria: July 29, 2024
• First Posted (Actual): August 1, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 13, 2025
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Antineoplastic Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Inflammatory Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Antirheumatic Agents; Sensory System Agents; Analgesics, Non-Narcotic; Analgesics; Anti-Inflammatory Agents, Non-Steroidal; Antioxidants; Protective Agents; Neuroprotective Agents; Antimutagenic Agents; Anticarcinogenic Agents; Curcumin; Epigallocatechin gallate
• Other Study ID Numbers: AU-STUDY00000014

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No