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
- Phase
- Early Phase 1
- Intervention
- Not specified
- Conditions
- Mood Disturbance
- Sponsor
- Auburn University
- Enrollment
- 64
- Locations
- 1
- Primary Endpoint
- Changes in total distress as measured via DASS-21 total score.
- Status
- Recruiting
- Last Updated
- last year
Overview
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)
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.
Investigators
Aidan Cavanah
Graduate Assistant
Auburn University
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
Outcomes
Primary Outcomes
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
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
- Changes in DASS-21 subscales (depression, anxiety, stress).(8-weeks)
- Changes in subjective physical activity.(8-weeks)
- Changes in fasting alanine aminotransferase (ALT)(8-weeks)
- Changes in subjective sleep quality.(8-weeks)
- Changes in fasting aspartate aminotransferase (AST)(8-weeks)
- Changes in diet quality.(8-weeks)
- Number of Participants who report daily adherence to supplementation intake(8-weeks)