Low Starch Dietary Education Program vs. Traditional Treatment for PCOS

Study Overview
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Brief Summary
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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
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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).

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

Conditions
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PCOS, Diet Modification, Metabolism, Nutrition Disorders

Intervention / Treatment
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* Drug: Metformin
* Other: One-On-One Dietary Instruction
* Other: Video Dietary Instruction


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Traditional Treatment<br>Participant receives recommendations for caloric intake, exercise and prescription for metformin if indicated | Drug: Metformin<br>* Traditional care including diet, exercise and metformin<br>* Other names: Traditional care;|
| Other: One-On-One Low Starch Dietary Instruction<br>Participant receives One-On-One Low Starch Dietary Instruction from Study Collaborator | Other: One-On-One Dietary Instruction<br>* Participant receives one-on-one dietary counseling from study personnel<br>|
| Other: Low Starch Dietary Instruction by Video<br>Participant receives Low Starch Dietary Instruction by Video Link | Other: Video Dietary Instruction<br>* Participant receives video dietary instruction<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PCOS, Diet, Video Instruction