Infertility, Female, Obesity & Overweight
Conditions
Keywords
Infertility, Reproductive Hormones, Low-Fat Diet, Obesity, Hypothalamic-pitutary-ovarian axis
Brief 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.
Detailed 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.
Interventions
DIETARY_SUPPLEMENTLow-fat diet
Participants will eat a one-month eucaloric high-fat diet.
Sponsors
University of Colorado, Denver
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
Yes
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%
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Urinary Pregnadiol Glucouronide concentration in ug/mg creatinine | From enrollment for 4 months post enrollment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Amount of Urinary estrogen | From enrollment to 4 months | Urinary estrogen concentration in microgram/mg of Creatinine |
Countries
United States
Outcome results
None listed