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Curcumin and EGCG Supplementation to Improve Serum BDNF and Mood Disturbance

ConditionMood Disturbance
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-50
SponsorAuburn University

About this trial

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)

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

Currently consume curcumin or green tea daily

Currently, pregnant, nursing, or trying to become pregnant

Currently diagnosed with a perimenopausal disorder

Trial design

Design model

Parallel

Treatments tested in this trial

  • Curcumin

    Dietary supplement

    1,330 mg curcumin

  • Epigallocatechin Gallate

    Dietary supplement

    350 mg Epigallocatechin gallate (EGCG)

  • Placebo

    Other intervention

    Placebo to be consumed after randomization.

Treatment groups

64 Participants
are divided into 2 treatment groups
Group A: Curcumin and EGCG SupplementationExperimental treatment 2 interventions
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
8-weeks
2

Changes in serum brain derived neurotrophic factor (BDNF).

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

Time frame
8-weeks

Secondary outcomes

1

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

Time frame
8-weeks
2

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"

Time frame
8-weeks
3

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.

Time frame
8-weeks
4

Changes in diet quality.

Using diet recalls over the past 24 hours.

Time frame
8-weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Auburn University

Lead sponsor

Source ClinicalTrials.gov
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