Assessment of Cod Protein as an Insulin-sensitizing Agent in Women With Polycystic Ovary Syndrome.
Condition: Insulin Sensitivity; Polycystic Ovarian Syndrome
MeSH terms: Polycystic Ovary Syndrome; Insulin Resistance; Hypersensitivity; Syndrome
Study type: Interventional

Summary: 
      The objective of our study is to determine the effects of fish protein on insulin sensitivity
      in PCOS women with insulin resistance, and its mechanism of action on glucose and endocrine
      metabolism. Our working hypothesis is that dietary fish protein improves insulin sensitivity,
      glucose tolerance, and related plasma endocrine and lipid abnormalities in PCOS women by
      restoring secretory β-cell function and insulin signaling to the PI 3-kinase activity/Akt
      pathway. We further hypothesize that fish protein will improve cycle regularity and ovarian
      function.
    

Detailed description: 
      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).
    

Intervention name(s): Semi-controlled nutritional intervention with fish protein diet; Semi-controlled intervention with other animal proteins
Intervention type(s): Other; Other
Intervention description(s): After a controlled NCEP-based diet for 3 months, women are assigned to a cod fillet diet. At the end of this first 3 months experimental period, participants return to their NCEP-based diet for a wash-out period of 3 months. Then, each group receive the other diet for an additional 3 months period. The fish protein intake come from cod fillets and correspond to 50% of total protein, the remaining dietary proteins being from BPVEM (20%) and vegetable (30%). Lunches incorporating cod fillets are prepared by professional dietitians, provided two time per week, and are self-consumed. Participants make their breakfasts and dinners using foods from a pre-approved list. Alcohol is strictly prohibited during all periods.; Prior to experimental period, participants follow a controlled NCEP-based diet for 3 months. Then women are assigned to a diet containing beef, pork, veal, eggs, milk and milk products. At the end of this first 3 months experimental period, participants return to their NCEP-based diet for a wash-out period of 3 months. The two diets are isoenergetic. The protein intake from BPVEM correspond to 70% of total protein, other dietary proteins are from vegetable (30%) origin. Lunches incorporating animal proteins are prepared by professional dietitians, provided two time per week, and are self-consumed. Participants make their breakfasts and dinners using foods from a pre-approved list. The content in n-3 fatty acids is adjusted to provide equivalent amounts of n-3 fatty acids then in the cod protein diet. Alcohol is strictly prohibited during all periods.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Polycystic ovarian syndrome, sex hormones, ovarian function, women, fish protein, insulin sensitivity, glucose tolerance, β-cell function, inflammation