Clinical trial
Dietary Reversal of the Reprometabolic Syndrome
Active, not recruiting · Not applicable · 1 countries · Registry ID NCT07227766
Active, not recruitingNot applicableInterventional
What this study is about
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.
A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.
Basic eligibility
Age18 Years to 40 Years
SexFemale
Healthy volunteersAccepted
ConditionObesity & Overweight, Infertility, Female
Full registry 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%
Treatments and study arms
Low-fat diet
Dietary Supplement
Participants will eat a one-month eucaloric high-fat diet.
Primary outcomes
Urinary Pregnadiol Glucouronide concentration in ug/mg creatinineFrom enrollment for 4 months post enrollment
Study locations
1 locations were listed when this page was built. The first 40 are shown.
University of Colorado School of Medicine🇺🇸 Aurora, Colorado, United States