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Low Starch Dietary Education Program vs. Traditional Treatment for PCOS

Primary Purpose

PCOS, Diet Modification, Metabolism

Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Metformin
One-On-One Dietary Instruction
Video Dietary Instruction
Sponsored by
Texas Tech University Health Sciences Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for PCOS focused on measuring PCOS, Diet, Video Instruction

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Texas Tech Health Science Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Other

Other

Arm Label

Traditional Treatment

One-On-One Low Starch Dietary Instruction

Low Starch Dietary Instruction by Video

Arm Description

Participant receives recommendations for caloric intake, exercise and prescription for metformin if indicated

Participant receives One-On-One Low Starch Dietary Instruction from Study Collaborator

Participant receives Low Starch Dietary Instruction by Video Link

Outcomes

Primary Outcome Measures

Weight
Weight
BMI
BMI

Secondary Outcome Measures

waist to hip ratio
waist to hip ratio
fasting glucose
fasting glucose
fasting insulin
fasting insulin
cholesterol
cholesterol
testosterone
testosterone
hemoglobin A1c
hemoglobin A1c

Full Information

First Posted
January 21, 2019
Last Updated
August 4, 2023
Sponsor
Texas Tech University Health Sciences Center
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1. Study Identification

Unique Protocol Identification Number
NCT03916263
Brief Title
Low Starch Dietary Education Program vs. Traditional Treatment for PCOS
Official Title
Compare Weight Loss and Metabolic Improvements Using a Low Starch Dietary Education Program vs. Traditional Treatment for Polycystic Ovary Syndrome (PCOS)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
August 29, 2018 (Actual)
Primary Completion Date
October 10, 2022 (Actual)
Study Completion Date
December 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Texas Tech University Health Sciences Center

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
PCOS, Diet Modification, Metabolism, Nutrition Disorders
Keywords
PCOS, Diet, Video Instruction

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Model Description
Prospective Randomized
Masking
None (Open Label)
Allocation
Randomized
Enrollment
71 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Traditional Treatment
Arm Type
Experimental
Arm Description
Participant receives recommendations for caloric intake, exercise and prescription for metformin if indicated
Arm Title
One-On-One Low Starch Dietary Instruction
Arm Type
Other
Arm Description
Participant receives One-On-One Low Starch Dietary Instruction from Study Collaborator
Arm Title
Low Starch Dietary Instruction by Video
Arm Type
Other
Arm Description
Participant receives Low Starch Dietary Instruction by Video Link
Intervention Type
Drug
Intervention Name(s)
Metformin
Other Intervention Name(s)
Traditional care
Intervention Description
Traditional care including diet, exercise and metformin
Intervention Type
Other
Intervention Name(s)
One-On-One Dietary Instruction
Intervention Description
Participant receives one-on-one dietary counseling from study personnel
Intervention Type
Other
Intervention Name(s)
Video Dietary Instruction
Intervention Description
Participant receives video dietary instruction
Primary Outcome Measure Information:
Title
Weight
Description
Weight
Time Frame
8 weeks
Title
BMI
Description
BMI
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
waist to hip ratio
Description
waist to hip ratio
Time Frame
8 weeks
Title
fasting glucose
Description
fasting glucose
Time Frame
8 weeks
Title
fasting insulin
Description
fasting insulin
Time Frame
8 weeks
Title
cholesterol
Description
cholesterol
Time Frame
8 weeks
Title
testosterone
Description
testosterone
Time Frame
8 weeks
Title
hemoglobin A1c
Description
hemoglobin A1c
Time Frame
8 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jennifer L Phy, DO
Organizational Affiliation
Texas Tech University Health Sciences Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Texas Tech Health Science Center
City
Lubbock
State/Province
Texas
ZIP/Postal Code
79430
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Will post to Clinical Trials
IPD Sharing Time Frame
2 years
IPD Sharing Access Criteria
2 years

Learn more about this trial

Low Starch Dietary Education Program vs. Traditional Treatment for PCOS

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