Ignite Creation Date:
2024-05-06 @ 7:56 PM
Last Modification Date:
2024-10-26 @ 3:17 PM
Study NCT ID:
NCT06188598
Status:
RECRUITING
Last Update Posted:
2024-01-05
First Post:
2023-12-18
Brief Title:
Time-restricted Eating in Peri- and Postmenopausal Women
Sponsor:
Brigham and Womens Hospital
Organization:
Brigham and Womens Hospital
Study Overview
Official Title:
Time-restricted Eating as a Dietary Intervention for Dyslipidemia in Peri- and Postmenopausal Women
Status:
RECRUITING
Status Verified Date:
2024-01
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:
The overall objective of the study is to examine the effect of an 8-hour time-restricted eating intervention on lipid levels and body composition in peri- and recently postmenopausal women with untreated dyslipidemia
Detailed Description:
This is a randomized controlled trial investigating the effects of an 8-TRE intervention compared to ad libitum eating control on metabolic health and body composition in recently postmenopausal women with untreated dyslipidemia Following a 1-week baseline assessment participants will be randomized to either a TRE or unrestricted control diet schedule 1-to-1 ratio for 8 weeks At baseline and weeks 4 and 8 of the intervention daily eating and sleep patterns will be assessed for one week followed by collection of fasting lipids and metabolic labs body weight and vital signs questionnaires assessing sleep and mood health actigraphy and body composition via whole-body dual-energy x-ray absorptiometry will be assessed at baseline and week 8
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