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Low Starch Dietary Education Program vs. Traditional Treatment for PCOS

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ClinicalTrials.gov Identifier: NCT03916263
Recruitment Status : Not yet recruiting
First Posted : April 16, 2019
Last Update Posted : July 15, 2019
Sponsor:
Information provided by (Responsible Party):
Texas Tech University Health Sciences Center

Brief 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.

Condition or disease Intervention/treatment Phase
PCOS Diet Modification Metabolism Nutrition Disorders Drug: Metformin Other: One-On-One Dietary Instruction Other: Video Dietary Instruction Early Phase 1

Detailed Description:

Polycystic ovary syndrome (PCOS) is a common gynecologic condition diagnosed by the presence of irregular menstruation, high androgen levels and polycystic appearing ovaries by ultrasound. PCOS affects approximately 5 million women of reproductive age in the United States and is associated with increased risk of obesity, diabetes, cardiovascular disease, cancer and infertility. Women with PCOS are at 5- to 10-fold risk of developing type 2 diabetes and are diagnosed on average 30 years sooner than women without PCOS. Historically, high insulin levels worsen symptoms of PCOS and make weight loss very difficult despite the patient's best efforts. Research shows that carbohydrates from dairy and starch-based foods have greater insulin-producing properties than carbohydrates from non-starchy vegetables and fruits. The purpose of this study is to compare 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.

In the investigator's previous work, study participants received approximately 1.5 hours of one-on-one dietary instruction by a Registered Dietitian. Dietary instruction included review of a list of foods that participants could eat with no restrictions as well as a list of foods to avoid, i.e. grains and dairy products. Study participants, all of whom were overweight or obese, achieved an average weight loss of 18.9 pounds in 8 weeks. In addition, study participants demonstrated improvements in triglycerides, total and free testosterone and in clinical hair growth scores. This study will investigate whether the same positive results might be achieved using a web-based written and video program for dietary guidance. If successful, the dietary video instructions may potentially benefit a large number of women by providing health care providers with a practical and affordable method to provide dietary instructions to their patients with PCOS, especially in areas where access to a Registered Dietitian is limited.

The goal of this prospective, randomized, controlled, clinical trial is to develop a practical, clinically useful web-based tool for health care providers to educate their patients on an optimal eating plan to manage PCOS.

AIM:

1.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.

METHODS:

Sixty overweight women with PCOS will be recruited to participate in an 8-week low starch diet with pre- and post-study measurements of weight, body mass index, waist to hip ratio, fasting glucose and insulin, complete lipid panel, free and total testosterone, and hemoglobin A1c. Patients will be randomized 1:1 to receive web-based instruction for a low starch diet or to receive face to face nutritional and diet information, or to receive a traditional care plan (metformin if indicated, low calorie diet, and exercise).


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 71 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Prospective Randomized
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Compare Weight Loss and Metabolic Improvements Using a Low Starch Dietary Education Program vs. Traditional Treatment for Polycystic Ovary Syndrome (PCOS)
Estimated Study Start Date : October 15, 2019
Estimated Primary Completion Date : January 15, 2021
Estimated Study Completion Date : January 15, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Traditional Treatment
Participant receives recommendations for caloric intake, exercise and prescription for metformin if indicated
Drug: Metformin
Traditional care including diet, exercise and metformin
Other Name: Traditional care

One-On-One Low Starch Dietary Instruction
Participant receives One-On-One Low Starch Dietary Instruction from Study Collaborator
Other: One-On-One Dietary Instruction
Participant receives one-on-one dietary counseling from study personnel

Low Starch Dietary Instruction by Video
Participant receives Low Starch Dietary Instruction by Video Link
Other: Video Dietary Instruction
Participant receives video dietary instruction




Primary Outcome Measures :
  1. Weight [ Time Frame: 8 weeks ]
    Weight

  2. BMI [ Time Frame: 8 weeks ]
    BMI


Secondary Outcome Measures :
  1. waist to hip ratio [ Time Frame: 8 weeks ]
    waist to hip ratio

  2. fasting glucose [ Time Frame: 8 weeks ]
    fasting glucose

  3. fasting insulin [ Time Frame: 8 weeks ]
    fasting insulin

  4. cholesterol [ Time Frame: 8 weeks ]
    cholesterol

  5. testosterone [ Time Frame: 8 weeks ]
    testosterone

  6. hemoglobin A1c [ Time Frame: 8 weeks ]
    hemoglobin A1c



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Women ages 18-45
  • BMI of >25 but < 45
  • PCOS
  • Access to a computer/phone/electronic device with internet connection.

Exclusion Criteria:

  • Pregnancy
  • Abnormal thyroid stimulating hormone (TSH)
  • Hyperprolactinemia
  • adrenal hyperplasia
  • Cushing's disease Ovarian and adrenal tumors. Previous diagnosis of diabetes. History of eating disorder History of surgical weight loss procedure Persons with an inability to give informed consent Persons unable/unwilling to exercise or to prepare their own food

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03916263


Contacts
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Contact: Jennifer L Phy, DO 806-743-4256 jennifer.phy@ttuhsc.edu
Contact: Kelsey Jendrzey, CCRC 806-743-3607 kelsey.jendrzey@ttuhsc.edu

Locations
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United States, Texas
Texas Tech Health Science Center
Lubbock, Texas, United States, 79430
Sponsors and Collaborators
Texas Tech University Health Sciences Center
Investigators
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Principal Investigator: Jennifer L Phy, DO Texas Tech University Health Sciences Center

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Responsible Party: Texas Tech University Health Sciences Center
ClinicalTrials.gov Identifier: NCT03916263     History of Changes
Other Study ID Numbers: L18-147
First Posted: April 16, 2019    Key Record Dates
Last Update Posted: July 15, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Will post to Clinical Trials
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: 2 years
Access Criteria: 2 years

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Texas Tech University Health Sciences Center:
PCOS
Diet
Video Instruction

Additional relevant MeSH terms:
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Nutrition Disorders
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs