Curcumin and EGCG Supplementation to Improve Serum BDNF and Mood Disturbance
- Conditions
- Mood Disturbance
- Interventions
- Dietary Supplement: CurcuminOther: PlaceboDietary Supplement: Epigallocatechin Gallate
- Registration Number
- NCT06531863
- Lead Sponsor
- Auburn University
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 64
- 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
- Currently consume curcumin or green tea daily
- Currently, pregnant, nursing, or trying to become pregnant
- Currently diagnosed with a perimenopausal disorder
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Curcumin and EGCG Supplementation Curcumin Participants in the intervention group with consume 1,500mg/day curcumin with 300mg/day EGCG. Placebo Placebo Participants will receive a placebo to consume everyday. Curcumin and EGCG Supplementation Epigallocatechin Gallate Participants in the intervention group with consume 1,500mg/day curcumin with 300mg/day EGCG.
- Primary Outcome Measures
Name Time Method Changes in total distress as measured via DASS-21 total score. 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). 8-weeks Serum BDNF will be measured via commercial ELISA kits. Higher levels of serum BDNF are optimal.
- Secondary Outcome Measures
Name Time Method Changes in DASS-21 subscales (depression, anxiety, stress). 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
Changes in subjective physical activity. 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.
Changes in fasting alanine aminotransferase (ALT) 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.
Changes in subjective sleep quality. 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"
Changes in fasting aspartate aminotransferase (AST) 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.
Changes in diet quality. 8-weeks Using diet recalls over the past 24 hours.
Number of Participants who report daily adherence to supplementation intake 8-weeks Number of participants that report consuming supplement \>80% of days via daily text messages
Trial Locations
- Locations (1)
Auburn University School of Kinesiology
🇺🇸Auburn, Alabama, United States