Dietary Reversal of the Reprometabolic Syndrome (LFD)

University of Colorado Denver (CU Denver)

Status

Active, not recruiting

Conditions

Obesity & Overweight

Infertility, Female

Treatments

Dietary Supplement: Low-fat diet

Study type

Interventional

Funder types

Other

Identifiers

NCT07227766

23-1702

Details and patient eligibility

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.

Full description

This an open-label, multi site study in pre-menopausal women aged 18-40 years old with a history of regular menstrual cycles (25-35 days long) of high BMI. The objective of the study will be to determine the effects of a one month long, eucaloric low-fat diet on reproductive hormone levels in women with a high BMI. The study will occur over 4 menstrual cycle (approximately 4 months). During the study the participants will have a pre-diet cycle where no food will be consumed, an on-diet cycle where the customized low-fat diet will be consumed, and two post diet cycles. First morning voided urine will be collected during all four cycles along with 3 blood draws during the study. Participants will be asked to use a reliable barrier method of birth control or abstain from intercourse during the study.

Enrollment

30 estimated patients

Sex

Female

Ages

18 to 40 years old

Volunteers

Accepts Healthy Volunteers

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%