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.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
Change in polycystic ovary syndrome disease measures from baseline
At baseline, before TLC lead-in, twice during the intervention, at 6 months follow-up and at 12 months follow-up
No
Gordon A Zello, PhD
Principal Investigator
University of Saskatchewan
Canada: University of Saskatchewan Biomedical Research Ethics Board
Pulse-PCOS
NCT01288638
January 2011
December 2013
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