Who is eligible for clinical trial NCT07227766?

Participants must meet protocol criteria for Obesity & Overweight. Confirm exact inclusion and exclusion requirements with the study coordinator.

Does clinical trial NCT07227766 provide travel or cost reimbursement?

Check with the site coordinator at the participating facility for travel and lodging stipend availability, and for which routine-care costs are covered.

🏛️ Verified NIH Record • Updated 2025-11-12

Dietary Reversal of the Reprometabolic Syndrome (NCT07227766)

🔵 Active, Not Recruiting Observational / Diagnostic 📋 Clinical Research Protocol Sponsor: University of Colorado, Denver

🩺 Plain-English Summary (8th-Grade Level)

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 join: To join this study, participants generally need to meet the listed inclusion criteria (7 items) and avoid the listed exclusions (5 items).

Location: University of Colorado School of Medicine — Aurora, Colorado

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

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)

Usually NOT eligible if any of the following apply:

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%

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (1 Sites)

University of Colorado School of Medicine — Aurora, Colorado

💰 Cost, Insurance & Patient Rights

100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

🏛️ View Official NIH Record ↗