NCT03987854

The University of Michigan PCOS Intervention Using Nutritional Ketosis

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 29 (actual)
• Sponsor: University of Michigan · Academic / Other
• Sex: Female
• Age: 21 Years – 40 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Polycystic Ovary Syndrome

Interventions

Type	Name	Description
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).

Timeline

• Start date: 2019-07-05
• Primary completion: 2020-03-01
• Completion: 2020-03-01
• First posted: 2019-06-17
• Last updated: 2022-10-25
• Results posted: 2022-10-25

Locations

1 site across 1 country: United States