CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 29 enrolled
Drug / intervention
diet and lifestyle programbehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03987854
NCT03987854Phase 2Completed
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The University of Michigan PCOS Intervention Using Nutritional Ketosis

University of Michigan·interventional·Posted Jun 17, 2019·Updated Oct 25, 2022

In Brief

A Phase 2 clinical trial evaluating diet and lifestyle program for Polycystic Ovary Syndrome. Completed, enrolled 29 participants across 1 site.

Detailed Summary

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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPolycystic Ovary Syndrome
CountriesUnited States
CollaboratorsNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Timeline

Phase 2CompletedFinished
2020202120222023202420252026
First PostedJun 17, 2019
Enrollment StartJul 5, 2019
Primary CompletionMar 1, 2020
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 7.0 years ago

Interventions

diet and lifestyle programbehavioral

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).