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Baseline Assessment of Dietary Intake and Physical Activity in Women With Polycystic Ovary Syndrome (PCOS)

18 Years
38 Years
Open (Enrolling)
Polycystic Ovary Syndrome, Dietary Habits, Physical Activity

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Trial Information

Baseline Assessment of Dietary Intake and Physical Activity in Women With Polycystic Ovary Syndrome (PCOS)

Polycystic ovary syndrome (PCOS) is an endocrine disorder that affects 6-12% of
reproductive-aged women within the general population. There has been evidence to suggest
women whom present with obesity and/or insulin resistance are at higher risk for developing
PCOS. This condition is associated with negative health implications. Women with PCOS women
are at increased risk for developing type 2 diabetes, metabolic syndrome and cardiovascular
disease compared to age- and weight- matched controls, indicating PCOS may increase an
individual's susceptibility for chronic disease.

Current research has failed to thoroughly examine the relationships between dietary intake,
energy expenditure and PCOS. The purpose of this proposed study is to identify lifestyle
factors associated with PCOS. Through dietary intake and energy expenditure data, the
researchers plan to examine potential lifestyle differences between PCOS and healthy women,
as well as between BMI classifications within women with PCOS. The Research Team will also
be able to evaluate the diet quality according to the USDA Dietary Guidelines for Americans
of all women included in the study. The Research Team is also interested in the
relationships between biological markers and lifestyle endpoints in women with and without
PCOS. Previous literature has shown there are biological marker differences between those
with and without PCOS. By examining these relationships, researchers may further understand
whether PCOS status is associated with lifestyle parameters.

To accomplish these objectives, 80 women (40 women with PCOS, 40 women without PCOS) will be
included in this study. Participants will be between 18 and 38 years, with BMI ≥ 18.5 kg/m2
and will not have use of oral contraceptives within the last three months. Women will be
included in the PCOS group if they have a confirmed PCOS diagnosis from their primary care
provider. Participants will complete a food frequency questionnaire and physical activity
questionnaire. A researcher may also provide participants with an accelerometer to wear for
a week. Ultrasound scans of the ovaries will be assessed for the total number and size of
follicles using both two- and three-dimensional imaging techniques. Participants will have
blood samples collected determine LH, FSH, estrogens, and progesterone levels. The following
metabolic parameters will be assessed: (1) 75-gram oral glucose tolerance test to
characterize glucose and insulin dynamics at 0, 30, 60, 90, and 120 minutes post-glucose
ingestion; (2) dual X-ray absorptiometry (DXA) scan to quantify body fat and lean muscle
distribution; (3) vitals and anthropometry assessment to measure waist and hip
circumference, height, weight, blood pressure, and heart rate, and (4) fasting blood tests
to detect androgens (i.e., total testosterone, androstenedione, free androgen index) and
serum markers of metabolic syndrome (i.e., lipids and hemoglobin A1C).

Inclusion Criteria:

- Between 18 and 38 years

- BMI ≥ 18.5 kg/m2

- In PCOS if: Confirmed PCOS diagnosis from their primary care provider

Exclusion Criteria:

- Use of oral contraceptives

- Significant weight changes within the last three months

Type of Study:


Study Design:

Observational Model: Case Control, Time Perspective: Retrospective

Outcome Measure:

Differences in diet composition between women with and without PCOS

Outcome Description:

A food frequency questionnaire will be administered to assess diet composition for the last three months.

Outcome Time Frame:

1 week

Safety Issue:


Principal Investigator

Marla E. Lujan, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Cornell University


United States: Institutional Review Board

Study ID:

IRB 1303003665



Start Date:

May 2013

Completion Date:

August 2014

Related Keywords:

  • Polycystic Ovary Syndrome
  • Dietary Habits
  • Physical Activity
  • Polycystic Ovary Syndrome (PCOS)
  • Diet
  • Exercise
  • Questionnaires
  • Polycystic Ovary Syndrome
  • Food Habits



Human Metabolic Research Unit, Cornell UniversityIthaca, New York  14853