Vitamin D and Omega-3 Inhibit Metabolic Syndrome

NCT ID: NCT01326442

Last Updated: 2013-06-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-04-30

Study Completion Date

2012-12-31

Brief Summary

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The study will test the hypothesis that supplementing the diet of subjects with Metabolic Syndrome with 2000 IU vitamin D and 1.8 g omega-3 fatty acids (EPA + DHA) per day, will facilitate weight loss, improve body composition and reduce metabolic and biochemical risk factors associated with type II diabetes and cardiovascular disease. Adult men and women who meet the International Diabetes Federation criteria for Metabolic Syndrome will be enrolled and embark on a 16 week diet and exercise intervention using a low glycemic index diet with or without the supplementary vitamin D and omega-3. Subjects will be counseled weekly and blood collected at weeks 0 and 16.

Detailed Description

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Conditions

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Type 2 Diabetes Mellitus Hypertension Hyperlipidemia Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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diet only

low glycemic index diet, calorie restricted with exercise 3 times per week.

Group Type EXPERIMENTAL

low glycemic diet

Intervention Type OTHER

a low glycemic diet, calorie restricted with exercise sessions 3 times per week

supplemented

2000 IU vitamin D3 plus 1.8 g EPA + DHA

Group Type ACTIVE_COMPARATOR

low glycemic diet

Intervention Type OTHER

a low glycemic diet, calorie restricted with exercise sessions 3 times per week

vitamin D omega-3

Intervention Type DIETARY_SUPPLEMENT

2000 IU vitamin D3 plus 1.8 g EPA + DHA per day for 16 weeks.

Interventions

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low glycemic diet

a low glycemic diet, calorie restricted with exercise sessions 3 times per week

Intervention Type OTHER

vitamin D omega-3

2000 IU vitamin D3 plus 1.8 g EPA + DHA per day for 16 weeks.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* must have Metabolic Syndrome as defined by International Diabetes Federation
* must be able to swallow tablets and capsules
* must be 18 years of age or older
* must be physically capable of moderate intensity exercise

Exclusion Criteria

* pregnant or lactating
* vegetarian
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Guelph

OTHER

Sponsor Role lead

Responsible Party

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Kelly Anne Meckling, PhD

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kelly A Meckling, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Guelph

Locations

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University of Guelph

Guelph, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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2011MeckVitD

Identifier Type: -

Identifier Source: org_study_id

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