Low Starch Dietary Education Program vs. Traditional Treatment for PCOS

NCT ID: NCT03916263

Last Updated: 2023-08-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 71 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-08-29
• Study Completion Date: 2022-12-31

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).

Conditions

PCOS; Diet Modification; Metabolism; Nutrition Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Traditional Treatment

Participant receives recommendations for caloric intake, exercise and prescription for metformin if indicated

Group Type: EXPERIMENTAL

Metformin

Intervention Type: DRUG

Traditional care including diet, exercise and metformin

One-On-One Low Starch Dietary Instruction

Participant receives One-On-One Low Starch Dietary Instruction from Study Collaborator

Group Type: OTHER

One-On-One Dietary Instruction

Intervention Type: OTHER

Participant receives one-on-one dietary counseling from study personnel

Low Starch Dietary Instruction by Video

Participant receives Low Starch Dietary Instruction by Video Link

Group Type: OTHER

Video Dietary Instruction

Intervention Type: OTHER

Participant receives video dietary instruction

Interventions

Metformin

Traditional care including diet, exercise and metformin

Intervention Type: DRUG

One-On-One Dietary Instruction

Participant receives one-on-one dietary counseling from study personnel

Intervention Type: OTHER

Video Dietary Instruction

Participant receives video dietary instruction

Intervention Type: OTHER

Other Intervention Names

Traditional care

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Texas Tech University Health Sciences Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jennifer L Phy, DO

Role: PRINCIPAL_INVESTIGATOR

Texas Tech University Health Sciences Center

Locations

Texas Tech Health Science Center

Lubbock, Texas, United States

Countries

United States

Other Identifiers

L18-147

Identifier Type: -

Identifier Source: org_study_id