Assessment of Cod Protein as an Insulin-sensitizing Agent in Women With Polycystic Ovary Syndrome.
Women with polycystic ovary syndrome are at high risk of developing diabetes. Apart from a
primary ovarian defect, up to 10% and 40-50% of those women develop diabetes and insulin
resistance (IR) respectively. IR and associated hyperinsulinemia are recognized as important
pathogenic factors in determining diabetes in the majority of PCOS women, particularly when
obesity is present. Treating IR might reduce the risk of diabetes and improve ovulation and
fertility in PCOS women. We recently found that obese, IR men and women consuming a cod
protein diet showed a 30% improvement in insulin sensitivity compared with other animal
proteins, and also a 24% decrease in high-sensitive C-reactive protein plasma concentration.
Therefore, dietary fish protein could represent a natural, safe and practical means to
improve insulin sensitivity in PCOS women with IR, and a new non-pharmaceutical approach for
the treatment of the multiple endocrine and metabolic abnormalities of PCOS women (see
outcome measures for a more extensive description).
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Change in sex hormones, during intervention and from baseline to the end of each intervention period.
Detailed plasma androgen profile including active androgens (testosterone and dihydrotestosterone), adrenal androgens (androstenedione, dehydroepiandrosterone and its sulphate), major glucuronide-conjugated androgen metabolites, plasma levels of the sex hormone transport protein Sex Hormone-Binding Globulin (SHBG).
At baseline, after the wash-out period, at the end of each intervention period (12 weeks), and at weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 and 11 during the intervention.
No
Canada: Canadian Institutes of Health Research
PCOS-09-08-078
NCT01766557
August 2010
June 2013
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