NCT07227766Active, not recruiting
Dietary Reversal of the Reprometabolic Syndrome
Source: ClinicalTrials.gov · Last updated 14 Nov 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- First submitted
- 11 Nov 2025
- Start date
- 10 Aug 2024
- Primary completion date
- 30 Dec 2028
- Lead sponsor
- University of Colorado, Denver
- Diseases
- Obesity
- NCT number
- NCT07227766
What you commit to
- Study type: Interventional
- Planned participants: 30
- From 10 Aug 2024 to the primary completion date, 30 Dec 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Lab values
- HbA1C \>6.5%
Other
- 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
Who the study is looking for
- 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)
Age in the registry: 18 years to 40 years · Sex: Female · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Colorado School of Medicine Coordinator of this site? Confirm its status | Aurora | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.