...

Dietary Reversal of the Reprometabolic Syndrome

This study wants to learn more about how the food we eat affects the reproductive hormones of adult women with obesity.


Why this Research Matters

This study wants to see how a low-fat diet affects reproductive hormones without causing weight change. If you join this study, you will complete 4 study visits. At the first visit, we will take a small blood sample from your arm using a needle, do a physical exam, and ask about your diet and period. When your period starts, you will collect your urine every morning until it ends. You will do this while eating your normal diet. At the end of this menstrual cycle, you will come in for a visit. When your next period starts, you will collect your urine every morning and eat the low-fat meals we give you. You will have a study visit twice a week for about 30 days. At these visits, we will check your weight and give you more study meals. After eating the low-fat diet, you will come in for a visit where we take a small blood sample, just like at your first visit. Then, you will need to collect your urine every morning while eating your normal diet for one more menstrual cycle. After that, you will have one last study visit. The study will last about 4 months, depending on how long your period lasts.


Who can Participate

Adult

You may qualify for the study if you: are a woman aged 18 to 38 years old with regular periods, have a BMI>30 kg/m2, are not taking any medications that contain hormones or affect hormones, have normal TSH, prolactin, and ovarian reserve levels when tested, are willing to use a non-hormonal method of contraception, and are not planning to get pregnant.


Study ID

Protocol Number: 23-1702

Meet the Team

Image of Principal Investigator

Nanette Santoro, MD

Principal Investigator


Locations