Low Starch Dietary Education Program vs. Traditional Treatment for PCOS
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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).
Study Design
Arms and Interventions
| 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:
|
| 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
|
Outcome Measures
Primary Outcome Measures
- Weight [8 weeks]
Weight
- BMI [8 weeks]
BMI
Secondary Outcome Measures
- waist to hip ratio [8 weeks]
waist to hip ratio
- fasting glucose [8 weeks]
fasting glucose
- fasting insulin [8 weeks]
fasting insulin
- cholesterol [8 weeks]
cholesterol
- testosterone [8 weeks]
testosterone
- hemoglobin A1c [8 weeks]
hemoglobin A1c
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Texas Tech Health Science Center | Lubbock | Texas | United States | 79430 |
Sponsors and Collaborators
- Texas Tech University Health Sciences Center
Investigators
- Principal Investigator: Jennifer L Phy, DO, Texas Tech University Health Sciences Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- L18-147