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Low Starch Dietary Education Program vs. Traditional Treatment for PCOS

NCT03916263 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 71

Last updated 2023-08-07

No results posted yet for this 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.

Conditions

  • PCOS
  • Diet Modification
  • Metabolism
  • Nutrition Disorders

Interventions

DRUG

Metformin

Traditional care including diet, exercise and metformin

OTHER

One-On-One Dietary Instruction

Participant receives one-on-one dietary counseling from study personnel

OTHER

Video Dietary Instruction

Participant receives video dietary instruction

Sponsors & Collaborators

  • Texas Tech University Health Sciences Center

    lead OTHER

Principal Investigators

  • Jennifer L Phy, DO · Texas Tech University Health Sciences Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-08-29
Primary Completion
2022-10-10
Completion
2022-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03916263 on ClinicalTrials.gov