The University of Michigan PCOS Intervention Using Nutritional Ketosis

Polycystic Ovary Syndrome Clinical Trial

Official title:

The University of Michigan PCOS Intervention Using Nutritional Ketosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03987854
• Other study ID #: HUM00113697
• Secondary ID: P30DK092926K01DK
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: July 5, 2019
• Est. completion date: March 1, 2020

Study information

• Verified date: October 2022
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this proposal is to pilot test our existing very-low carbohydrate diet intervention, adapted for women with PCOS.

Description:

Polycystic ovary syndrome (PCOS) is a common and costly ($4.3 billion/year) endocrine disorder that significantly impairs quality of life and increases the risk of obesity and type 2 diabetes as well as hyperandrogenism, infertility, hyperlipidemia, and cardiovascular disease. Diet and lifestyle weight-loss interventions are recommended as the first-line treatment of PCOS, but experts disagree about which nutritional approach is best. A review of previous diet and lifestyle trials in PCOS did find a slight benefit of lower carbohydrate diets for weight loss, glucose control, insulin, and insulin resistance. This may be because carbohydrate intake leads to increased insulin secretion, which then stimulates ovarian androgen production and inhibits the release of fatty acids from cells, both of which worsen PCOS-related issues. Although lower carbohydrate diets may be helpful, research from other populations with or at risk of type 2 diabetes suggests that prior PCOS studies may have set insufficient carbohydrate reduction targets. The investigators propose that a very-low carbohydrate diet may be needed to especially benefit women with PCOS, as greater carbohydrate reduction should have a larger impact on androgen levels and weight loss. Thus, the goal of this proposal is to pilot test our existing very-low carbohydrate diet intervention, adapted for women with PCOS.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: March 1, 2020
• Est. primary completion date: March 1, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years to 40 Years

Eligibility

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 <0.45 mIU/ML or >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.

Related Conditions & MeSH terms

• Polycystic Ovary Syndrome

Intervention

Behavioral:
• diet and lifestyle program
Participants will be taught how to follow a very low carbohydrate, ketogenic diet, become more physically active, and get adequate sleep. They will also be taught taught about positive affect skills (such as gratitude, positive reappraisal, and personal strengths) and mindfulness (general mindfulness and mindful eating).

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Polycystic Ovary Syndrome Questionnaire (PCOSQ): Emotions	Scale measures health-related quality-of-life for Women with PCOS with five domains: emotions, body hair, weight, infertility, and menstrual problems. It is a 7-point scale questionnaire assessing health-related quality of life specific to PCOS in 5 different domains, with "7" representing optimal function and "1" representing poorest function.	4 months
Other	Polycystic Ovary Syndrome Questionnaire (PCOSQ): Body Hair	Scale measures health-related quality-of-life for Women with PCOS with five domains: emotions, body hair, weight, infertility, and menstrual problems. It is a 7-point scale questionnaire assessing health-related quality of life specific to PCOS in 5 different domains, with "7" representing optimal function and "1" representing poorest function.	4 months
Other	Polycystic Ovary Syndrome Questionnaire (PCOSQ): Weight	Scale measures health-related quality-of-life for Women with PCOS with five domains: emotions, body hair, weight, infertility, and menstrual problems. It is a 7-point scale questionnaire assessing health-related quality of life specific to PCOS in 5 different domains, with "7" representing optimal function and "1" representing poorest function.	4 months
Other	Polycystic Ovary Syndrome Questionnaire (PCOSQ): Infertility	Scale measures health-related quality-of-life for Women with PCOS with five domains: emotions, body hair, weight, infertility, and menstrual problems. It is a 7-point scale questionnaire assessing health-related quality of life specific to PCOS in 5 different domains, with "7" representing optimal function and "1" representing poorest function.	4 months
Other	Polycystic Ovary Syndrome Questionnaire (PCOSQ): Menstrual Symptoms	Scale measures health-related quality-of-life for Women with PCOS with five domains: emotions, body hair, weight, infertility, and menstrual problems. It is a 7-point scale questionnaire assessing health-related quality of life specific to PCOS in 5 different domains, with "7" representing optimal function and "1" representing poorest function.	4 months
Other	Polycystic Ovary Syndrome Questionnaire (PCOSQ): Menstrual Predictability	Scale measures health-related quality-of-life for Women with PCOS with five domains: emotions, body hair, weight, infertility, and menstrual problems. It is a 7-point scale questionnaire assessing health-related quality of life specific to PCOS in 5 different domains, with "7" representing optimal function and "1" representing poorest function.	4 months
Primary	Mean Percent Body Weight Loss	Mean percent body weight loss was defined as: (weight at 4 months - baseline weight) / (baseline weight) *100.	4 months
Secondary	HbA1c Change	percentage of glycosylated hemoglobin	4 months