NCT07227766

Dietary Reversal of the Reprometabolic Syndrome

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: University of Colorado, Denver · Academic / Other
• Sex: Female
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

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.

Conditions

• Obesity & Overweight
• Infertility, Female

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Low-fat diet	Participants will eat a one-month eucaloric high-fat diet.

Timeline

• Start date: 2024-08-10
• Primary completion: 2028-12-30
• Completion: 2029-12-30
• First posted: 2025-11-13
• Last updated: 2025-11-14

Locations

1 site across 1 country: United States