Dietary Reversal of the Reprometabolic Syndrome (NCT07227766) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Dietary Reversal of the Reprometabolic Syndrome
United States30 participantsStarted 2024-08-10
Plain-language 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.
Who can participate
Age range18 Years – 40 Years
SexFEMALE
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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%
What they're measuring
1
Urinary Pregnadiol Glucouronide concentration in ug/mg creatinine
Timeframe: From enrollment for 4 months post enrollment