Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06531863
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-16
Brief Title:
Curcumin and EGCG Supplementation to Improve Serum BDNF and Mood Disturbance
Sponsor:
None
Organization:
None
Study Overview
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 moderate depression 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
1500mgday curcumin
300mgday epigallocatechin gallate EGCG
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
1500mgday curcumin
300mgday 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 1330mgday curcumin and 350mgday EGCG Baseline mood disturbance questionnaires DASS-21 GAD-7 GSAQ IPAQ and serum BDNF will be taken prior to intervention and again after intervention
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 1330mgday curcumin and 350mgday 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None