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Vitamin D and Omega-3 Inhibit Metabolic Syndrome

Primary Purpose

Type 2 Diabetes Mellitus, Hypertension, Hyperlipidemia

Status
Completed
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
low glycemic diet
vitamin D omega-3
Sponsored by
University of Guelph
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes Mellitus focused on measuring weight loss, overweight, body composition, visceral obesity, insulin, glucose tolerance, cholesterol, hypertriglyceridemia

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Guelph

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

diet only

supplemented

Arm Description

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

2000 IU vitamin D3 plus 1.8 g EPA + DHA

Outcomes

Primary Outcome Measures

body weight
body weight will be measured to nearest 0.5 kg weekly

Secondary Outcome Measures

Blood pressure
systolic and diastolic blood pressure will be measured in duplicate, weekly
Blood lipids
blood lipids will be measured at baseline and after study completion.
Glucose homeostasis
fasting blood glucose, insulin, HbA1c, CRP, cytokines and inflammatory markers will be measured at weeks 0 and 16 of the intervention.

Full Information

First Posted
March 29, 2011
Last Updated
June 12, 2013
Sponsor
University of Guelph
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1. Study Identification

Unique Protocol Identification Number
NCT01326442
Brief Title
Vitamin D and Omega-3 Inhibit Metabolic Syndrome
Official Title
Phase 3 Study of Vitamin D and Omega-3 Supplementation to Reduce Risk of Metabolic Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
April 2011 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Guelph

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus, Hypertension, Hyperlipidemia, Obesity
Keywords
weight loss, overweight, body composition, visceral obesity, insulin, glucose tolerance, cholesterol, hypertriglyceridemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
diet only
Arm Type
Experimental
Arm Description
low glycemic index diet, calorie restricted with exercise 3 times per week.
Arm Title
supplemented
Arm Type
Active Comparator
Arm Description
2000 IU vitamin D3 plus 1.8 g EPA + DHA
Intervention Type
Other
Intervention Name(s)
low glycemic diet
Intervention Description
a low glycemic diet, calorie restricted with exercise sessions 3 times per week
Intervention Type
Dietary Supplement
Intervention Name(s)
vitamin D omega-3
Intervention Description
2000 IU vitamin D3 plus 1.8 g EPA + DHA per day for 16 weeks.
Primary Outcome Measure Information:
Title
body weight
Description
body weight will be measured to nearest 0.5 kg weekly
Time Frame
up to 16 weeks
Secondary Outcome Measure Information:
Title
Blood pressure
Description
systolic and diastolic blood pressure will be measured in duplicate, weekly
Time Frame
up to 16 weeks
Title
Blood lipids
Description
blood lipids will be measured at baseline and after study completion.
Time Frame
up to 16 weeks
Title
Glucose homeostasis
Description
fasting blood glucose, insulin, HbA1c, CRP, cytokines and inflammatory markers will be measured at weeks 0 and 16 of the intervention.
Time Frame
up to 16 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kelly A Meckling, PhD
Organizational Affiliation
University of Guelph
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Guelph
City
Guelph
State/Province
Ontario
ZIP/Postal Code
N1G2W1
Country
Canada

12. IPD Sharing Statement

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Vitamin D and Omega-3 Inhibit Metabolic Syndrome

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