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NCT Number: NCT06531863

Curcumin and EGCG Supplementation to Improve Serum BDNF and Mood Disturbance

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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Key information

Conditions

Mood Disturbance

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Auburn University School of Kinesiology

Auburn, Alabama, 36849, United States

Location status: Recruiting

Location contact

Drew Fruge, PhD

CONTACT

[email protected]

3448448433

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Curcumin

Dietary Supplement

1,330 mg curcumin

Epigallocatechin gallate

Dietary Supplement

350 mg Epigallocatechin gallate (EGCG)

Other names: EGCG

Placebo

Other

Placebo to be consumed after randomization.

Primary outcomes

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

    Time frame: 8-weeks

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

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

    Time frame: 8-weeks

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

Secondary outcomes

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

    Time frame: 8-weeks

    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

  2. Changes in subjective sleep quality.

    Time frame: 8-weeks

    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"

  3. Changes in subjective physical activity.

    Time frame: 8-weeks

    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.

  4. Changes in diet quality.

    Time frame: 8-weeks

    Using diet recalls over the past 24 hours.

  5. Number of Participants who report daily adherence to supplementation intake

    Time frame: 8-weeks

    Number of participants that report consuming supplement >80% of days via daily text messages

  6. Changes in fasting alanine aminotransferase (ALT)

    Time frame: 8-weeks

    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.

  7. Changes in fasting aspartate aminotransferase (AST)

    Time frame: 8-weeks

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Aidan Cavanah, MSc

CONTACT

[email protected]

2057893258

Andrew Fruge, PhD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Auburn University

Other

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 1, 2024
Registry last updated
Feb 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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