Curcumin and EGCG Supplementation to Improve Serum BDNF and Mood Disturbance
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Curcumin, Epigallocatechin Gallate, Placebo.
- Who it may be relevant to
- Registry conditions: Mood Disturbance. Basic parameters: 18 years — 50 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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.
Interventions
- Dietary supplement Curcumin
1,330 mg curcumin - Dietary supplement Epigallocatechin Gallate
350 mg Epigallocatechin gallate (EGCG) - Other Placebo
Placebo to be consumed after randomization.
Primary outcome measures
- Changes in total distress as measured via DASS-21 total score. [Time frame: 8-weeks]
- Changes in serum brain derived neurotrophic factor (BDNF). [Time frame: 8-weeks]
Secondary outcome measures (7)
- Changes in DASS-21 subscales (depression, anxiety, stress). [Time frame: 8-weeks]
- Changes in subjective sleep quality. [Time frame: 8-weeks]
- Changes in subjective physical activity. [Time frame: 8-weeks]
- Changes in diet quality. [Time frame: 8-weeks]
- Number of Participants who report daily adherence to supplementation intake [Time frame: 8-weeks]
- Changes in fasting alanine aminotransferase (ALT) [Time frame: 8-weeks]
- Changes in fasting aspartate aminotransferase (AST) [Time frame: 8-weeks]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Auburn University School of Kinesiology — Auburn
Identifiers
NCT: NCT06531863 · AU-STUDY00000014