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

Primary Purpose

Insulin Sensitivity, Polycystic Ovarian Syndrome

Status

Completed

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

Semi-controlled nutritional intervention with fish protein diet

Semi-controlled intervention with other animal proteins

About this trial

This is an interventional treatment trial for Insulin Sensitivity focused on measuring Polycystic ovarian syndrome, sex hormones, ovarian function, women, fish protein, insulin sensitivity, glucose tolerance, β-cell function, inflammation

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleAccepts 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)

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Semi-controlled intervention with fish protein diet

Semi-controlled intervention with other animal proteins

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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).

Change in cycle regularity during intervention period.

menstrual diaries

Change in ovarian function during intervention period.

progesterone measurements

Secondary Outcome Measures

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

Food frequency questionnaire

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

Total cholesterol, LDL-cholesterol, HDL-cholesterol, triglycerides, glucose and insulin concentrations during a 180-min euglycemic-hyperinsulinemic clamp, GDR, MI, β-cell function, systolic and diastolic blood pressure, glucose and insulin concentrations during a 120-min oral glucose tolerance test, plasma C-peptide concentration, apolipoprotein apoA-1, A-2 and B plasma concentrations, hsCRP, MCP-1, IL-1β, IL-6 and adiponectin concentrations.

Muscle insulin signaling

Muscle biopsies for expression and phosphorylation of IRS-1-associated PI3-K activity, as well as Akt and aPKC activation by insulin.

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

Physical activity habits questionnaire

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

anthropometric measurements (body mass index, waist and hip circumferences)

Full Information

NCT ID

NCT01766557

First Posted

October 2, 2012

Last Updated

February 6, 2014

Sponsor

Laval University

Collaborators

Institute of Nutraceuticals and Functional Foods, Canadian Diabetes Association, Diabetes Québec

1. Study Identification

Unique Protocol Identification Number

NCT01766557

Brief Title

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

Acronym

PCOS

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2014

Overall Recruitment Status

Completed

Study Start Date

August 2010 (undefined)

Primary Completion Date

December 2012 (Actual)

Study Completion Date

December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Laval University

Collaborators

Institute of Nutraceuticals and Functional Foods, Canadian Diabetes Association, Diabetes Québec

4. Oversight

Data Monitoring Committee

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Insulin Sensitivity, Polycystic Ovarian Syndrome

Keywords

Polycystic ovarian syndrome, sex hormones, ovarian function, women, fish protein, insulin sensitivity, glucose tolerance, β-cell function, inflammation

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

9 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Semi-controlled intervention with fish protein diet

Arm Type

Experimental

Arm Description

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

Arm Title

Semi-controlled intervention with other animal proteins

Arm Type

Active Comparator

Arm 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.

Intervention Type

Other

Intervention Name(s)

Semi-controlled nutritional intervention with fish protein diet

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

Semi-controlled intervention with other animal proteins

Intervention Description

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.

Primary Outcome Measure Information:

Title

Change in sex hormones, during intervention and from baseline to the end of each intervention period.

Description

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.

Title

Change in cycle regularity during intervention period.

Description

menstrual diaries

Time Frame

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

Title

Change in ovarian function during intervention period.

Description

progesterone measurements

Time Frame

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

Secondary Outcome Measure Information:

Title

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

Description

Food frequency questionnaire

Time Frame

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

Title

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

Description

Time Frame

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)

Title

Muscle insulin signaling

Description

Muscle biopsies for expression and phosphorylation of IRS-1-associated PI3-K activity, as well as Akt and aPKC activation by insulin.

Time Frame

After each intervention period (12 weeks)

Title

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

Description

Physical activity habits questionnaire

Time Frame

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

Title

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

Description

anthropometric measurements (body mass index, waist and hip circumferences)

Time Frame

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

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

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)

Facility Information:

Facility Name

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

City

Quebec

ZIP/Postal Code

G1V 0A6

Country

Canada

12. IPD Sharing Statement

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

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