Ignite Creation Date:
2024-05-06 @ 8:04 PM
Last Modification Date:
2024-10-26 @ 3:20 PM
Study NCT ID:
NCT06242665
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-07-12
First Post:
2024-01-16
Brief Title:
You Are What You Eat Food as a Risk Factor and a Treatment for Depression
Sponsor:
University of Michigan
Organization:
University of Michigan
Study Overview
Official Title:
You Are What You Eat Food as a Risk Factor and a Treatment for Depression
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study experimentally investigates 1 whether ultra processed food UPF intake contributes to depression by increasing low mood and poor sleep due to blood glucose fluctuations which then increases the desire to consume more UPFs and 2 to investigate the effectiveness of a 2-week meal-kit intervention that provides convenient and tasty minimally processed foods MPF to reduce depression The following aims and hypotheses are tested
Aim 1 To investigate whether UPF intake and low mood contribute to each other in a cyclical fashion through the mechanisms of blood glucose fluctuations and disrupted sleep in individuals with moderate-to-severe depression
H1 It is hypothesized that UPF intake and high blood glucose will be associated with low mood in individuals with depression
Aim 2 To establish an industry partnership to investigate whether commercially available meal kit delivery reduces symptoms of depression in individuals with moderate-to-severe depression relative to a nutrition education control condition
H2 Meal kit delivery will lead to reductions in depression symptoms and daily reductions in low mood relative to the control condition nutrition guidance only
Aim 1 To investigate whether UPF intake and low mood contribute to each other in a cyclical fashion through the mechanisms of blood glucose fluctuations and disrupted sleep in individuals with moderate-to-severe depression
H1 It is hypothesized that UPF intake and high blood glucose will be associated with low mood in individuals with depression
Aim 2 To establish an industry partnership to investigate whether commercially available meal kit delivery reduces symptoms of depression in individuals with moderate-to-severe depression relative to a nutrition education control condition
H2 Meal kit delivery will lead to reductions in depression symptoms and daily reductions in low mood relative to the control condition nutrition guidance only
Detailed Description:
The study will include a combination of in-person at-home and virtual activities over the course of 21 days contingent on scheduling this duration may vary and particularly between in-person visits 1 and 2 Participants complete three in-lab visits each followed by a week of remote data tasks eg ecological momentary assessment continuous glucose monitoring and physical activity and sleep tracking Fitbit
During in-lab visit 1 participants will complete questionnaires and interviews have a continuous glucose monitor inserted and will have body composition measurements taken height weight Inbody scan Participants will complete the remote tasks for the following week while eating their typical diet ie baseline period
During in-lab visit 2 participants will complete questionnaires interviews and body composition measurements height weight Inbody scan Participants are randomly assigned to a meal delivery will receive two weeks of low UPF meals and nutrition guidance or control will receive some snacks and nutrition guidance condition ie dietary intervention period Participants will complete the remote tasks for the following two weeks
During in-lab visit 3 participants will complete questionnaires interviews and body composition measurements height weight InBody scan
Participants are contacted 1- and 6-months later to complete a short follow-up survey and provide information about their current diet
During in-lab visit 1 participants will complete questionnaires and interviews have a continuous glucose monitor inserted and will have body composition measurements taken height weight Inbody scan Participants will complete the remote tasks for the following week while eating their typical diet ie baseline period
During in-lab visit 2 participants will complete questionnaires interviews and body composition measurements height weight Inbody scan Participants are randomly assigned to a meal delivery will receive two weeks of low UPF meals and nutrition guidance or control will receive some snacks and nutrition guidance condition ie dietary intervention period Participants will complete the remote tasks for the following two weeks
During in-lab visit 3 participants will complete questionnaires interviews and body composition measurements height weight InBody scan
Participants are contacted 1- and 6-months later to complete a short follow-up survey and provide information about their current diet
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None