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NCT03987854 · ClinicalTrials.gov registry record · Phase 1

The University of Michigan PCOS Intervention Using Nutritional Ketosis

A Phase 1 study, sponsored by University of Michigan.

Completed
Registry status
Phase 1
Development phase
29
Enrollment target

NCT03987854: Completed Phase 1 study, sponsored by University of Michigan.

NCT03987854 is a Phase 1 study that has completed, run by University of Michigan. The registered enrollment target is 29 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (52% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03987854, a Phase 1 study, has completed, sponsored by University of Michigan.

COMPLETED
Registry status
Phase 1
Development phase
29 participants
Enrollment target

Study Summary

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

Primary Outcome

Mean percent body weight loss was defined as: (weight at 4 months - baseline weight) / (baseline weight) \*100.

Interventions

  • BEHAVIORAL diet and lifestyle program

Trial Details

FieldValue
Enrollment Target 29 participants
Start Date 2019-07-05
Est. Completion 2020-03-01
Phase Phase 1
University of Michigan

1,327 total trials

What the finished NCT03987854 record still lists

NCT03987854 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 29 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (52% lower).

The record links to 0 conditions, and to 1 intervention - of which diet and lifestyle program is the first listed.

NCT03987854 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03987854 about?

NCT03987854 is a clinical study titled "The University of Michigan PCOS Intervention Using Nutritional Ketosis". The goal of this proposal is to pilot test our existing very-low carbohydrate diet intervention, adapted for women with PCOS.

What is the current status of trial NCT03987854?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 29 participants. The study started on 2019-07-05. Estimated completion is 2020-03-01.

What interventions are being tested in trial NCT03987854?

The interventions under investigation include: diet and lifestyle program (BEHAVIORAL).

Who is sponsoring clinical trial NCT03987854?

This trial is sponsored by University of Michigan, which has 1,327 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT03987854's enrollment target sits among peer trials

29 1440th of 2000 higher than 554 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT03987854, the US trial registry maintained by the National Library of Medicine. NCT03987854 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.