Fish Gelatin Supplement and Omega-3 Supplement in Obese o... | NCT01215903

Studies
Fish Gelatin Supplement and Omega-3 Supplement in Obese or Overweight Subjects With Insulin Resistance

NCT01215903

Sponsor

Laval University

Status

Completed

Last Update Posted

Oct 25, 2010Estimated

Enrollment

21Actual

Phase

Phase 2

Conditions

Insulin Resistance
Type 2 Diabetes

Interventions

Fish gelatin and omega-3 polyunsaturated fatty acid
Omega-3 polyunsaturated fatty acid

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2007

Primary Completion Date

May 2009Actual

Completion Date

May 2009Actual

First Submitted Date

Oct 5, 2010

First Submission Date that Met QC Criteria

Oct 6, 2010

First Posted Date

Oct 7, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 22, 2010

Last Update Posted Date

Oct 25, 2010Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

Laval UniversityOTHER

Collaborators

Name	Class
Advance Foods and Materials Network	OTHER
Institut des Nutraceutiques et Aliments fonctionnels, Quebec (Clinical nutrition facilities)	UNKNOWN
University of Guelph	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The present study was conducted to test whether a fish gelatin supplement combined with an omega-3 polyunsaturated fatty acid supplement can exert beneficial and sex-specific effects on insulin sensitivity, glucose tolerance, indicators of insulin secretion, blood pressure, lipid metabolism, inflammation and energy intake in obese or overweight insulin-resistant men and women. The investigators hypothesis is that fish gelatin improves insulin sensitivity, glucose tolerance, lipid profile and reduces inflammation in obese or overweight insulin-resistant men and women.

Detailed Description

An important number of recent epidemiological studies have demonstrated the beneficial effects of marine omega-3 polyunsaturated fatty acids (n-3 PUFA) on cardiovascular disease risk factors such as reduced triglycerides, decreased platelet aggregation, plaque stabilization, antiarrhythmic effects, and reduced blood pressure. Dietary fish protein has also been shown to improve insulin sensitivity by 30% in insulin-resistant obese or overweight human subjects. In addition, an increasing number of studies describe and demonstrate the physiological and metabolic variations between men and women in regard to CVD and their risk factors, including type 2 diabetes, but the data are still limited. In agreement with the recent findings, this study was conducted to evaluate the combined and synergistic effects of omega-3 and fish protein supplements on insulin sensitivity, blood pressure, lipid metabolism and inflammation in obese or overweight insulin-resistant men and women having some or all the metabolic syndrome criteria including a deteriorated lipid profile, high blood pressure and high waist circumference in a free living situation.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

21Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Fish gelatin and omega-3	Experimental		Dietary Supplement: Fish gelatin and omega-3 polyunsaturated fatty acid
Omega-3	Experimental		Dietary Supplement: Omega-3 polyunsaturated fatty acid

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Fish gelatin and omega-3 polyunsaturated fatty acid	Dietary Supplement		Fish gelatin and omega-3
Omega-3 polyunsaturated fatty acid

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Insulin sensitivity		At 8 weeks
Plasma lipids and lipoproteins		at 8 weeks
Blood pressure		At 8 weeks
Plasma and serum inflammatory markers		At 8 weeks

Secondary Outcomes

Measure	Description	Time Frame
Glucose tolerance		At 8 weeks
Energy intake		At 8 weeks
Fatty acids of phospholipids in skeletal muscle

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

overweight or obese (body mass index [BMI] between 25 and 40kg/m2)
fasting plasma glucose below 7.0mmol/L and 2-h plasma glucose below 11.1mmol/L
fasting plasma insulin above 90pmol/L

Exclusion Criteria:

Diabetes, chronic, metabolic or acute disease
Major surgery within the last 3 months
Significant weight loss (±10%) within the last 6 months
Any medication-taking known to affect lipid of glucose metabolism
Allergy, intolerance or dislike of fish
Smokers

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Helene Jacques, PhD	Laval University	Principal Investigator
Andre Marette, PhD	Laval University	Principal Investigator
John S Weisnagel, MD/FRCPC	Laval University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Laval University		Québec	Quebec	G1V 0A6	Canada

Condition Browse Module

MeSH Terms

ID	Term
D007333	Insulin Resistance
D003924	Diabetes Mellitus, Type 2

Ancestor Terms

ID	Term
D006946	Hyperinsulinism
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D004281	Docosahexaenoic Acids

Ancestor Terms

ID	Term
D015525	Fatty Acids, Omega-3
D004042	Dietary Fats, Unsaturated
D004041	Dietary Fats
D005223	Fats

Browse Leaves

Not provided

Browse Branches

Not provided