Low Starch Dietary Education Program vs. Traditional Treatment for PCOS
Condition: PCOS; Diet Modification; Metabolism; Nutrition Disorders
MeSH terms: Nutrition Disorders
Study type: Interventional
Phase: Early Phase 1

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).
    

Intervention name(s): Metformin; One-On-One Dietary Instruction; Video Dietary Instruction
Intervention type(s): Drug; Other; Other
Intervention description(s): Traditional care including diet, exercise and metformin; Participant receives one-on-one dietary counseling from study personnel; Participant receives video dietary instruction
Other intervention name(s): Traditional care
Intervention MeSH terms: Metformin
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Prospective Randomized
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: PCOS; Diet; Video Instruction