Mood Disturbance
Conditions
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.
Interventions
DIETARY_SUPPLEMENTCurcumin
1,330 mg curcumin
DIETARY_SUPPLEMENTEpigallocatechin Gallate
350 mg Epigallocatechin gallate (EGCG)
OTHERPlacebo
Placebo to be consumed after randomization.
Sponsors
Auburn University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
This is a double-blinded study with masking of participants and investigator using computer generated allocation sequences and sealed treatment and placebo supplement bags.
Intervention model description
Intervention Group (supplementation with 1330mg/day curcumin and 350mg/day EGCG)
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 diet quality. | 8-weeks | Using diet recalls over the past 24 hours. |
| 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 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 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. |
| 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 |
| 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 |
Countries
United States
Contacts
Primary ContactAidan Cavanah, MSc
Backup ContactAndrew Fruge, PhD
Outcome results
None listed