Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03916263 |
| Other study ID # |
L18-147 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
Early Phase 1
|
| First received |
|
| Last updated |
|
| Start date |
August 29, 2018 |
| Est. completion date |
December 31, 2022 |
Study information
| Verified date |
August 2023 |
| Source |
Texas Tech University Health Sciences Center |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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).
