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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Curcumin and EGCG Supplementation | Experimental | Participants in the intervention group with consume 1,330mg/day curcumin with 350mg/day EGCG. |
|
| Placebo | Placebo Comparator | Participants will receive a placebo to consume everyday. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Curcumin | Dietary Supplement | 1,330 mg curcumin |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 8-weeks |
| Changes in serum brain derived neurotrophic factor (BDNF). | Serum BDNF will be measured via commercial ELISA kits. Higher levels of serum BDNF are optimal. | 8-weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 8-weeks |
| Changes in subjective sleep quality. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Aidan Cavanah, MSc | Contact | 2057893258 | amc0108@auburn.edu | |
| Andrew Fruge, PhD | Contact | adf0003@auburn.edu |
| Name | Affiliation | Role |
|---|---|---|
| Andrew D Fruge, PhD | Auburn University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Auburn University School of Kinesiology | Recruiting | Auburn | Alabama | 36849 | United States |
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| ID | Term |
|---|---|
| D003474 | Curcumin |
| C045651 | epigallocatechin gallate |
| ID | Term |
|---|---|
| D036381 | Diarylheptanoids |
| D006536 | Heptanes |
| D000473 | Alkanes |
| D006839 | Hydrocarbons, Acyclic |
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Intervention Group (supplementation with 1330mg/day curcumin and 350mg/day EGCG)
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This is a double-blinded study with masking of participants and investigator using computer generated allocation sequences and sealed treatment and placebo supplement bags.
| Epigallocatechin Gallate |
| Dietary Supplement |
350 mg Epigallocatechin gallate (EGCG) |
|
|
| Placebo | Other | Placebo to be consumed after randomization. |
|
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" |
| 8-weeks |
| 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. | 8-weeks |
| Changes in diet quality. | Using diet recalls over the past 24 hours. | 8-weeks |
| Number of Participants who report daily adherence to supplementation intake | Number of participants that report consuming supplement >80% of days via daily text messages | 8-weeks |
| Changes in fasting alanine aminotransferase (ALT) | 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. | 8-weeks |
| Changes in fasting aspartate aminotransferase (AST) | 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. | 8-weeks |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D002396 | Catechols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |