Clinical trial NCT01766557: Assessment of Cod Protein as an Insulin-sensitizing Agent in Women With Polycystic Ovary Syndrome.
Official title: Assessment of Cod Protein as an Insulin-sensitizing Agent in Women With Polycystic Ovary Syndrome.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Insulin Sensitivity
Polycystic Ovarian Syndrome
Keywords: Polycystic ovarian syndrome, sex hormones, ovarian function, women, fish protein, insulin sensitivity, glucose tolerance, β-cell function, inflammation
Lead sponsor: Laval University
Sponsor class: OTHER
Collaborators: name: Institute of Nutraceuticals and Functional Foods
name: Canadian Diabetes Association
name: Diabetes Québec
First posted: 2013-01-11
Enrollment: 9
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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).

Eligibility criteria: 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)

Primary outcomes:
measure: Change in sex hormones, during intervention and from baseline to the end of each intervention period.
timeFrame: 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.
measure: Change in cycle regularity during intervention period.
timeFrame: At weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12 during the intervention
measure: Change in ovarian function during intervention period.
timeFrame: At weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12 during the intervention
Secondary outcomes:
measure: Change in nutritional variables from baseline to the end of each intervention period.
timeFrame: At baseline and at the end of the intervention period (12 weeks).
measure: Change in cardiometabolic statute from baseline to the end of each intervention period
timeFrame: At baseline (at the beginning of the intervention), after the 12 weeks wash-out period, and at the end of each intervention period (12 weeks each)
measure: Muscle insulin signaling
timeFrame: After each intervention period (12 weeks)
measure: Change in physical activity habits from baseline to the end of each intervention period.
timeFrame: At baseline and at the end of the intervention period (12 weeks)
measure: Change in anthropometric measurements from baseline to the end of each intervention period.
timeFrame: At baseline and at the end of the intervention period (12 weeks)
Other outcomes:
Locations:
city: Quebec
country: Canada
facility: Institute Of Nutraceuticals and Functional Foods (INAF), Laval University
Study officials:
References: