Assessment of Cod Protein as an Insulin-sensitizing Agent in Women With Polycystic Ovary Syndrome. (PCOS)

Laval University

Status: Completed

Conditions: Polycystic Ovarian Syndrome; Insulin Sensitivity

Treatments: Other: Semi-controlled nutritional intervention with fish protein diet; Other: Semi-controlled intervention with other animal proteins

Study type: Interventional

Funder types: Other

Identifiers

NCT01766557

PCOS-09-08-078

Details and patient eligibility

About

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.

Full 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).

Enrollment: 9 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

9 participants in 2 patient groups

Semi-controlled intervention with fish protein diet

Experimental group

Description:

Women with polycystic ovarian syndrome who are assigned to a 12 weeks experimental diet containing cod as the protein source.

Treatment:

Other: Semi-controlled nutritional intervention with fish protein diet

Semi-controlled intervention with other animal proteins

Active Comparator group

Description:

Women with polycystic ovarian syndrome who are assigned to a 12 week experimental diet containing beef, pork, veal, eggs and milk products (BPVEM) as protein sources.

Treatment:

Other: Semi-controlled intervention with other animal proteins