Dietary Reversal of the Reprometabolic Syndrome

NCT ID: NCT07227766

Last Updated: 2025-11-14

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-10
• Study Completion Date: 2029-12-30

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.

Conditions

Obesity & Overweight; Infertility, Female

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Low-Fat Diet

Participants will eat a customized, eucaloric low-fat diet for one month

Group Type: EXPERIMENTAL

Low-fat diet

Intervention Type: DIETARY_SUPPLEMENT

Participants will eat a one-month eucaloric high-fat diet.

Interventions

Low-fat diet

Participants will eat a one-month eucaloric high-fat diet.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• Normal TSH and prolactin
• Regular menstrual cycles every 25-40 days
• No history of chronic disease affecting hormone production, metabolism or clearance
• No use of reproductive hormones, or medications/supplements known to impact them, within 3 months of enrollment
• Use of a reliable method of contraception (female or male partner sterilization, IUD, abstinence, diaphragm or cervical cap)
• Normal ovarian reserve (AMH of 0.5ng/ml or greater)
• Normal testosterone levels at screening or absence of clinical evidence of hyperandrogenemia (acne, facial hirsutism [defined as Ferriman-Gallwey score>8] or alopecia)

Exclusion Criteria

• Baseline dietary assessment indicative of 28% or less daily calories from fat
• Inability to comply with the protocol (many meals per week eaten outside of the home, frequent travel)
• Pregnancy or planned pregnancy within next 6 months at time of screening
• HbA1C >6.5%

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Colorado, Denver

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nanette Santoro, MD

Role: PRINCIPAL_INVESTIGATOR

University of Colorado School of Medicine

Locations

University of Colorado School of Medicine

Aurora, Colorado, United States

Countries

United States

Other Identifiers

23-1702

Identifier Type: -

Identifier Source: org_study_id