Dietary Reversal of the Reprometabolic Syndrome

NCT07227766 | Active Not Recruiting

• 1 other identifier: 23-1702
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity & Overweight; Infertility, Female

Keywords

Infertility; Reproductive Hormones; Low-Fat Diet; Obesity; Hypothalamic-pitutary-ovarian axis

Outcome Measures

Primary Outcomes (1)

• Urinary Pregnadiol Glucouronide concentration in ug/mg creatinine

  From enrollment for 4 months post enrollment

Secondary Outcomes (1)

• Amount of Urinary estrogen

  From enrollment to 4 months

Study Arms (1)

Low-Fat Diet

EXPERIMENTAL

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

Dietary Supplement: Low-fat diet

Interventions

Low-fat diet DIETARY_SUPPLEMENT

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

Low-Fat Diet

Eligibility Criteria

• Age: 18 Years - 40 Years
• Gender Eligibility Details: This study examines female reproductive hormones.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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%

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (1)

University of Colorado School of Medicine

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Conditions

Obesity; Overweight; Infertility, Female; Infertility

Interventions

Diet, Fat-Restricted

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Nanette Santoro, MD

  University of Colorado School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 11, 2025
• First Posted: November 13, 2025
• Study Start: August 10, 2024
• Primary Completion (Estimated): December 30, 2028
• Study Completion (Estimated): December 30, 2029
• Last Updated: November 14, 2025

Record last verified: 2025-11

Locations

US (1)