Assessment of Cod Protein as an Insulin-sensitizing Agent in Women With Polycystic Ovary Syndrome.
18 Years
45 Years
Female
Insulin Sensitivity, Polycystic Ovarian Syndrome
Trial Information
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).
Inclusion Criteria:
- women
- 18 to 45 years old
- having polycystic ovarian syndrome
- overweight (BMI>27)
- insulin resistance based on fasting insulin levels in the upper 95th percentile
(>90pmol/L)
- non-diabetic
Exclusion Criteria:
- diabetes
- hysterectomy
- abnormal endometrial biopsy if abnormal bleeding in the last 6 months
- clinical evidence of Cushing's syndrome
- congenital adrenal hyperplasia (17-OH progesterone>10nmol/l)
- excessive androgens suspicious of a tumour
- prolactins levels >50μg/l
- previous breast, uterus, ovary or liver neoplasia
- use of medication known to affect glucose and lipid metabolisms (e.g. steroid
hormones, oral contraceptives, ß-blockers, glitazones, statins, insulin)
- depo-medroxyprogesterone acetate injection in the last year
- important weight loss or weight gain within the last 6 months
- chronic, metabolic (except well controlled chronic hypothyroidism) or acute disease
or major surgery within the last 3 months
- dietary incompatibility with calcium supplementation and/or fish consumption
(allergy, intolerance, dislike)
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Change in sex hormones, during intervention and from baseline to the end of each intervention period.
Outcome Description:
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).
Outcome Time Frame:
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.
Safety Issue:
No
Authority:
Canada: Canadian Institutes of Health Research
Study ID:
PCOS-09-08-078
NCT ID:
NCT01766557
Start Date:
August 2010
Completion Date:
June 2013
Related Keywords:
- Insulin Sensitivity
- Polycystic Ovarian Syndrome
- Polycystic ovarian syndrome, sex hormones, ovarian function, women, fish protein, insulin sensitivity, glucose tolerance, β-cell function, inflammation
- Polycystic Ovary Syndrome
- Insulin Resistance
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