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NCT03916263 · ClinicalTrials.gov registry record · Early Phase 1
Low Starch Dietary Education Program vs. Traditional Treatment for PCOS
A Early Phase 1 study, sponsored by Texas Tech University Health Sciences Center.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 71
- Enrollment target
NCT03916263: Completed Early Phase 1 study, sponsored by Texas Tech University Health Sciences Center.
NCT03916263 is a Early Phase 1 study that has completed, run by Texas Tech University Health Sciences Center. The registered enrollment target is 71 participants, above the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (34% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03916263, a Early Phase 1 study, has completed, sponsored by Texas Tech University Health Sciences Center.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 71 participants
- Enrollment target
Study Summary
Compare weight loss and metabolic parameters in patients using a low starch dietary education program vs. traditional treatment (i.e., prescribing metformin, low calorie diet and exercise) for health improvement in women with PCOS.
Primary Outcome
Weight
Interventions
- DRUG Metformin
- OTHER One-On-One Dietary Instruction
- OTHER Video Dietary Instruction
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 71 participants |
| Start Date | 2018-08-29 |
| Est. Completion | 2022-12-31 |
| Phase | Early Phase 1 |
What the finished NCT03916263 record still lists
NCT03916263 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 71 participants, a relatively small participant target, above the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (34% higher).
The record links to 0 conditions, and to 3 interventions - of which Metformin is the first listed.
NCT03916263 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03916263 about?
NCT03916263 is a clinical study titled "Low Starch Dietary Education Program vs. Traditional Treatment for PCOS". Compare weight loss and metabolic parameters in patients using a low starch dietary education program vs. traditional treatment (i.e., prescribing metformin, low calorie diet and exercise) for health improvement in women with PCOS.
What is the current status of trial NCT03916263?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 71 participants. The study started on 2018-08-29. Estimated completion is 2022-12-31.
What interventions are being tested in trial NCT03916263?
The interventions under investigation include: Metformin (DRUG), One-On-One Dietary Instruction (OTHER), Video Dietary Instruction (OTHER).
Who is sponsoring clinical trial NCT03916263?
This trial is sponsored by Texas Tech University Health Sciences Center, which has 76 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03916263's enrollment target sits among peer trials
71 328th of 2000 higher than 1,663 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early 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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