Mood DisturbanceEarly Phase 1NCT06531863
Curcumin and EGCG Supplementation to Improve Serum BDNF and Mood Disturbance
A Early Phase 1 study testing Curcumin and Epigallocatechin Gallate in people with Mood Disturbance, run by Auburn University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Mood Disturbance
- What is being tested?
- Curcumin and Epigallocatechin Gallate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Sep 2024to 1 Aug 2025
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- Currently consume curcumin or green tea daily
- Currently, pregnant, nursing, or trying to become pregnant
- Currently diagnosed with a perimenopausal disorder
Trial locations and contacts
1 site in 1 country.
Andrew Fruge, PhD contact
United States1 site, 1 recruiting
- Recruiting
Auburn University School of Kinesiology
Auburn, Alabama, 36849
Drew Fruge, PhD, 3448448433, adf0003@auburn.edu
About this study
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
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)
Read the 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.
- Conditions
- Mood Disturbance
- Being tested
- Curcumin, Epigallocatechin Gallate, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CurcuminDietary supplement
1,330 mg curcumin
Epigallocatechin GallateDietary supplement
Also called EGCG
350 mg Epigallocatechin gallate (EGCG)
PlaceboOther
Placebo to be consumed after randomization.
| Study group | Role | What they receive |
|---|---|---|
| Curcumin and EGCG Supplementation | Experimental | Participants in the intervention group with consume 1,330mg/day curcumin with 350mg/day EGCG. Receives: Dietary Supplement: Curcumin; Dietary Supplement: Epigallocatechin Gallate |
| Placebo | Placebo comparator | Participants will receive a placebo to consume everyday. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 8-weeks
Secondary outcomes (7)
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
Measured: 8-weeks
Changes in subjective sleep quality.
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"
Measured: 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.
Measured: 8-weeks
Changes in diet quality.
Using diet recalls over the past 24 hours.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 8-weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2024
- Study start30 Sep 2024
- Primary completion1 May 2025 (estimated)
- Study completion1 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mood DisturbanceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Intervention Group (supplementation with 1330mg/day curcumin and 350mg/day EGCG)
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Auburn University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aidan Cavanah, Auburn University
- Investigators
- Andrew D Fruge, PhD, Principal investigator, Auburn University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06531863
- Sponsor's protocol ID
- AU-STUDY00000014
- Status last verified
- Oct 2024
- First submitted
- 16 Jul 2024
- Last updated
- 14 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06531863
- Acronym / sponsor ID
- AU-STUDY00000014
- Conditions
- Mood Disturbance
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Auburn UniversityUniversity, hospital or other
- Study start
- 30 Sep 2024 (actual)
- Primary completion
- 1 May 2025 (estimated)
- Study completion
- 1 Aug 2025 (estimated)
- First posted
- 1 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Intervention Group (supplementation with 1330mg/day curcumin and 350mg/day EGCG)
| Arm | Type | Receives |
|---|---|---|
| Curcumin and EGCG Supplementation | Experimental | Dietary Supplement: Curcumin, Dietary Supplement: Epigallocatechin GallateParticipants in the intervention group with consume 1,330mg/day curcumin with 350mg/day EGCG. |
| Placebo | Placebo comparator | Other: PlaceboParticipants will receive a placebo to consume everyday. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Currently consume curcumin or green tea daily
- Currently, pregnant, nursing, or trying to become pregnant
- Currently diagnosed with a perimenopausal disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Curcumin1,330 mg curcumin | Dietary supplement | Curcumin and EGCG Supplementation |
| Epigallocatechin GallateAlso: EGCG350 mg Epigallocatechin gallate (EGCG) | Dietary supplement | Curcumin and EGCG Supplementation |
| PlaceboPlacebo to be consumed after randomization. | Other | Placebo |
Primary outcome
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.
7 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew Fruge, PhD contact
Andrew D Fruge, PhD principal investigator
Auburn University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Curcumin and Epigallocatechin Gallate in people with Mood Disturbance, run by Auburn University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Aidan Cavanah, MSc (2057893258, amc0108@auburn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in total distress as measured via DASS-21 total score. (time frame: 8-weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2025.