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

NCT01766557 | Completed

• 1 other identifier: PCOS-09-08-078
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (3)

• 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.

• Change in cycle regularity during intervention period.

  menstrual diaries

  At weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12 during the intervention

• Change in ovarian function during intervention period.

  progesterone measurements

  At weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12 during the intervention

Secondary Outcomes (5)

• Change in nutritional variables from baseline to the end of each intervention period.

  At baseline and at the end of the intervention period (12 weeks).

• Change in cardiometabolic statute from baseline to the end of each intervention period

  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)

• Muscle insulin signaling

  After each intervention period (12 weeks)

• Change in physical activity habits from baseline to the end of each intervention period.

  At baseline and at the end of the intervention period (12 weeks)

• Change in anthropometric measurements from baseline to the end of each intervention period.

  At baseline and at the end of the intervention period (12 weeks)

Study Arms (2)

Semi-controlled intervention with fish protein diet

EXPERIMENTAL

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

Other: Semi-controlled nutritional intervention with fish protein diet

Semi-controlled intervention with other animal proteins

ACTIVE COMPARATOR

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.

Other: Semi-controlled intervention with other animal proteins

Interventions

Semi-controlled nutritional intervention with fish protein diet OTHER

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.

Semi-controlled intervention with fish protein diet

Semi-controlled intervention with other animal proteins OTHER

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.

Semi-controlled intervention with other animal proteins

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• women
• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Laval University: lead
• Institute of Nutraceuticals and Functional Foods: collaborator
• Canadian Diabetes Association: collaborator
• Diabetes Québec: collaborator

Study Sites (1)

Institute Of Nutraceuticals and Functional Foods (INAF), Laval University

Québec, Quebec, G1V 0A6, Canada

Location

MeSH Terms

Conditions

Insulin Resistance; Polycystic Ovary Syndrome; Inflammation

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Ph.D., Dt.P.

Study Record Dates

• First Submitted: October 2, 2012
• First Posted: January 11, 2013
• Study Start: August 1, 2010
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2013
• Last Updated: February 7, 2014

Record last verified: 2014-02

Locations

CA (1)