Low Starch Dietary Education Program vs. Traditional Treatment for PCOS

Compare Weight Loss and Metabolic Improvements Using a Low Starch Dietary Education Program vs. Traditional Treatment for Polycystic Ovary Syndrome (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.

Study Overview

• Status: Completed
• Conditions: Nutrition Disorders; Diet Modification; PCOS; Metabolism
• Intervention / Treatment: Drug: Metformin; Other: One-On-One Dietary Instruction; Other: Video Dietary Instruction

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).

• Study Type: Interventional
• Enrollment (Actual): 71
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United States
  • Texas
    • Lubbock, Texas, United States, 79430
      • Texas Tech Health Science Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / 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 Names: Traditional care
Other: 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
Other: Low Starch Dietary Instruction by Video; Participant receives Low Starch Dietary Instruction by Video Link	Other: Video Dietary Instruction; Participant receives video dietary instruction

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weight	Weight	8 weeks
BMI	BMI	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
waist to hip ratio	waist to hip ratio	8 weeks
fasting glucose	fasting glucose	8 weeks
fasting insulin	fasting insulin	8 weeks
cholesterol	cholesterol	8 weeks
testosterone	testosterone	8 weeks
hemoglobin A1c	hemoglobin A1c	8 weeks

Collaborators and Investigators

• Sponsor: Texas Tech University Health Sciences Center
• Investigators: Principal Investigator: Jennifer L Phy, DO, Texas Tech University Health Sciences Center

Study record dates

Study Major Dates

• Study Start (Actual): August 29, 2018
• Primary Completion (Actual): October 10, 2022
• Study Completion (Actual): December 31, 2022

Study Registration Dates

• First Submitted: January 21, 2019
• First Submitted That Met QC Criteria: April 15, 2019
• First Posted (Actual): April 16, 2019

Study Record Updates

• Last Update Posted (Actual): August 7, 2023
• Last Update Submitted That Met QC Criteria: August 4, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: PCOS; Diet; Video Instruction
• Additional Relevant MeSH Terms: Nutrition Disorders; Hypoglycemic Agents; Physiological Effects of Drugs; Metformin
• Other Study ID Numbers: L18-147

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Will post to Clinical Trials
• IPD Sharing Time Frame: 2 years
• IPD Sharing Access Criteria: 2 years
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• 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