Ignite Creation Date:
2025-12-24 @ 4:16 PM
Ignite Modification Date:
2026-01-02 @ 1:54 AM
Study NCT ID:
NCT07227766
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-11-14
First Post:
2025-11-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dietary Reversal of the Reprometabolic Syndrome
Sponsor:
University of Colorado, Denver
Organization:
Study Overview
Official Title:
Dietary Reversal of the Reprometabolic Syndrome
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-11
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:
LFD
Brief Summary:
This study proposes to test the specific question that a eucaloric, low-fat diet given to women with obesity will result in an increase in reproductive hormones.
Detailed Description:
This an open-label, multi site study in pre-menopausal women aged 18-40 years old with a history of regular menstrual cycles (25-35 days long) of high BMI. The objective of the study will be to determine the effects of a one month long, eucaloric low-fat diet on reproductive hormone levels in women with a high BMI. The study will occur over 4 menstrual cycle (approximately 4 months). During the study the participants will have a pre-diet cycle where no food will be consumed, an on-diet cycle where the customized low-fat diet will be consumed, and two post diet cycles. First morning voided urine will be collected during all four cycles along with 3 blood draws during the study. Participants will be asked to use a reliable barrier method of birth control or abstain from intercourse during the study.
Study Oversight
Has Oversight DMC:
False
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?: