Clinical trial NCT03916263: 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
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: PCOS
Diet Modification
Metabolism
Nutrition Disorders
Keywords: PCOS
Diet
Video Instruction
Lead sponsor: Texas Tech University Health Sciences Center
Sponsor class: OTHER
First posted: 2019-04-16
Enrollment: 71
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective Randomized
Primary purpose: TREATMENT

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).

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

Primary outcomes:
measure: Weight
timeFrame: 8 weeks
measure: BMI
timeFrame: 8 weeks
Secondary outcomes:
measure: waist to hip ratio
timeFrame: 8 weeks
measure: fasting glucose
timeFrame: 8 weeks
measure: fasting insulin
timeFrame: 8 weeks
measure: cholesterol
timeFrame: 8 weeks
measure: testosterone
timeFrame: 8 weeks
measure: hemoglobin A1c
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Lubbock
country: United States
facility: Texas Tech Health Science Center
state: Texas
Study officials:
affiliation: Texas Tech University Health Sciences Center
name: Jennifer L Phy, DO
role: PRINCIPAL_INVESTIGATOR
References: