Very low-carbohydrate diet for Sclerocystic Ovaries

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
University of Michigan, Ann Arbor, MI
Sclerocystic Ovaries+1 More
Very low-carbohydrate diet - Behavioral
Eligibility
18 - 65
Female
What conditions do you have?
Select

Study Summary

This research will test whether a Dietary Approaches to Stop Hypertension (DASH) or a very low-carbohydrate diet better improves outcomes like blood glucose control and body weight for adults with polycystic ovary syndrome. Participants will have screening (includes blood draw) and baseline testing with a continuous glucose monitor and a body composition scan (called a dual-energy x-ray absorptiometry or DEXA). Once these enrollment steps are completed and the participants will be randomized to one of two 12-month programs.

Eligible Conditions

  • Sclerocystic Ovaries
  • Polycystic Ovarian Syndrome (PCOS)

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

0 Primary · 4 Secondary · Reporting Duration: 0-12 months

0 to 12 months
Change in glycemic variability
Change in percent body fat on DEXA
0 to 4 months
Change in HbA1c
0-12 months
Change in percent body weight loss

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

DASH diet
1 of 2
Very low-carbohydrate diet
1 of 2
Active Control
Experimental Treatment

184 Total Participants · 2 Treatment Groups

Primary Treatment: Very low-carbohydrate diet · No Placebo Group · N/A

Very low-carbohydrate diet
Behavioral
Experimental Group · 1 Intervention: Very low-carbohydrate diet · Intervention Types: Behavioral
DASH diet
Behavioral
ActiveComparator Group · 1 Intervention: DASH diet · Intervention Types: Behavioral

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 0-12 months

Trial Background

Prof. Laura Saslow, Assistant Professor
Principal Investigator
University of Michigan
Closest Location: University of Michigan · Ann Arbor, MI
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2022First Recorded Clinical Trial
0 TrialsResearching Sclerocystic Ovaries
1003 CompletedClinical Trials

Eligibility Criteria

Age 18 - 65 · Female Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have oligomenorrhea-anovulation.
You are on hormonal birth control or birth control that alters menstrual cycle timing, a history of irregular periods.
You are on hormonal birth control or birth control that alters menstrual cycle timing
You have low testosterone levels.\n
You have a menstrual period of < 21 days or > 35 days or a total of 8 or fewer menses per year.
DHEAS < 600 μg/dL.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.