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A Lifestyle Intervention for Women With Polycystic Ovary Syndrome: The Role of a Pulse-Based Diet and Aerobic Exercise on Infertility Measures and Metabolic Syndrome Risk


N/A
18 Years
35 Years
Open (Enrolling)
Female
Polycystic Ovary Syndrome, Metabolic Syndrome

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Trial Information

A Lifestyle Intervention for Women With Polycystic Ovary Syndrome: The Role of a Pulse-Based Diet and Aerobic Exercise on Infertility Measures and Metabolic Syndrome Risk


To date, we have developed the pulse-based and meat-based healthy meals following
Therapeutic Lifestyle Changes (TLC)guidelines recommended by NCEP for the intervention. We
have been recruiting and enrolling participants into the study with our few set of
participants having completed the 4 month intervention. Baseline data have been also
collected on all participants assessed for PCOS. Preliminary measurements on POCS
characteristics, baseline dietary and exercise habits of women with PCOS will be soon
available.

This study involves an intervention comparing a diet containing pulses (i.e. beans, peas,
chick peas, lentils) to a diet recommended by the National Cholesterol Education Program
(NCEP) for improving markers of metabolic syndrome and fertility in women with poly cystic
ovarian syndrome who are also enrolled in an aerobic exercise program. To date, seven women
in the pulse-diet group have completed the intervention, nine women in the group receiving
the NCEP diet have completed the intervention, four women are currently enrolled on the
pulse diet and two women are currently enrolled on the NCEP diet.


Inclusion Criteria:



- Female

- Diagnosis of PCOS

- Aged 18-35 years

Exclusion Criteria:

- Taking birth control or fertility medications

- Medical conditions that limit exercise or which limit consumption of a pulse-based
diet (allergies or intolerances)

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Outcome Measure:

Change in polycystic ovary syndrome disease measures from baseline

Outcome Time Frame:

At baseline, before TLC lead-in, twice during the intervention, at 6 months follow-up and at 12 months follow-up

Safety Issue:

No

Principal Investigator

Gordon A Zello, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Saskatchewan

Authority:

Canada: University of Saskatchewan Biomedical Research Ethics Board

Study ID:

Pulse-PCOS

NCT ID:

NCT01288638

Start Date:

January 2011

Completion Date:

December 2013

Related Keywords:

  • Polycystic Ovary Syndrome
  • Metabolic Syndrome
  • Polycystic Ovary Syndrome
  • Metabolic Syndrome
  • Pulse
  • Lifestyle Intervention
  • Aerobic Exercise
  • Diet
  • Polycystic Ovary Syndrome
  • Metabolic Syndrome X

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