Dietary Reversal of the Reprometabolic Syndrome (LFD)

November 12, 2025 updated by: University of Colorado, Denver
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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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%

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Low-Fat Diet
Participants will eat a customized, eucaloric low-fat diet for one month
Dietary supplement: Low-fat diet
Participants will eat a one-month eucaloric high-fat diet.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Urinary Pregnadiol Glucouronide concentration in ug/mg creatinine
Time Frame: From enrollment for 4 months post enrollment
From enrollment for 4 months post enrollment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Amount of Urinary estrogen
Time Frame: From enrollment to 4 months
Urinary estrogen concentration in microgram/mg of Creatinine
From enrollment to 4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Colorado, Denver

Investigators

  • Principal Investigator: Nanette Santoro, MD, University of Colorado School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 10, 2024

Primary Completion (Estimated)

December 30, 2028

Study Completion (Estimated)

December 30, 2029

Study Registration Dates

First Submitted

November 11, 2025

First Submitted That Met QC Criteria

November 11, 2025

First Posted (Estimated)

November 13, 2025

Study Record Updates

Last Update Posted (Estimated)

November 14, 2025

Last Update Submitted That Met QC Criteria

November 12, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 23-1702

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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