The University of Michigan PCOS Intervention Using Nutritional Ketosis

Inclusion Criteria

• We will include women in one PCOS subtype, those having these two symptoms:
• Hyperandrogenism - (a) If not on current birth control: hyperandrogenism defined as current elevated total testosterone >= 50 ng/dL or free androgen index > 1.5 (ratio of testosterone/SHBG x 100) or severe acne or hirsutism (b) if on current birth control: history from the past 10 years of hyperandrogenism defined as past elevated total testosterone >= 50 ng/dL or free androgen index > 1.5 (ratio of testosterone/SHBG x 100) or severe acne or hirsutism
• oligomenorrhea-anovulation defined as spontaneous intermenstrual periods of ≥ 45 days or a total of ≤ 8 menses per year.

Participants must also be:

• overweight or obese (BMI 25-50)
• be 21-40 years old
• have regular access to the internet
• be able to engage in light physical activity
• willing and able to follow the assigned intervention.

Exclusion Criteria

• a non-English speaker
• inability to complete baseline measurements
• a substance abuse, mental health, or medical condition that would interfere with participation (such as current chemotherapy)
• pregnant or planning to get pregnant in the next 6 months
• type 1 or type 2 diabetes
• baseline aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 2 times normal
• baseline renal disease defined as BUN > 30 mg/dL or serum creatinine >1.4 mg/dL
• baseline uncorrected thyroid disease (TSH 4.5 mIU/ML)
• breastfeeding or less than 6 months post-partum
• planned or history of weight loss surgery
• vegan or vegetarian
• currently enrolled in a weight loss program or other investigative study that might conflict with this research
• taking medications known to cause weight gain or loss
• taking hypoglycemic medications other than metformin or medications known to affect metabolism
• or patients with other etiologies of anovulation and hyperandrogenism, e.g., Cushing's disease, thyroid dysfunction, elevated prolactin levels, signs of congenital adrenal hyperplasia, organic intra cranial lesion such as a pituitary tumor, or suspected adrenal or ovarian tumor secreting androgens.