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

Status Completed

Clinical Trial Summary

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

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Polycystic Ovary Syndrome

• NCT number: NCT03987854
• Study type: Interventional
• Source: University of Michigan
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: July 5, 2019
• Completion date: March 1, 2020