Dietary Reversal of the Reprometabolic Syndrome

N/AActive Not RecruitingNCT07227766

University of Colorado, Denver30 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Obesity & Overweight Infertility, Female

Interventions

Low-fat dietDIETARY_SUPPLEMENT

Participants will eat a one-month eucaloric high-fat diet.

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 40 YearsHealthy volunteers:

Medical Language ↔ Plain English

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%

Locations (1)

University of Colorado School of Medicine

Aurora, Colorado, United States

Outcomes

Primary Outcomes

Urinary Pregnadiol Glucouronide concentration in ug/mg creatinine

Time frame: From enrollment for 4 months post enrollment

Secondary Outcomes

Amount of Urinary estrogen

Urinary estrogen concentration in microgram/mg of Creatinine

Time frame: From enrollment to 4 months

Data from ClinicalTrials.gov

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