Dietary Reversal of the Reprometabolic Syndrome

Running, not enrolling · Not applicable

Conditions studied: Obesity & Overweight, Infertility, Female

In brief

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.

Key facts

Study ID

NCT07227766

Run by

University of Colorado, Denver

People needed

30

Starts

2024-08-10

Expected to finish

2029-12-30

Last updated by the study team

2025-11-14

Who can join

Age: 18 and older, up to 40. Sex: female. Healthy volunteers: accepted.

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%

Where it is running

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

Full record on ClinicalTrials.gov

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