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Vitamin D and Omega-3 Inhibit Metabolic Syndrome

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Dr. Kelly Anne Meckling, PhD, University of Guelph
ClinicalTrials.gov Identifier:
NCT01326442
First received: March 29, 2011
Last updated: March 22, 2012
Last verified: March 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Type 2 Diabetes Mellitus
Hypertension
Hyperlipidemia
Obesity
 Other: low glycemic diet
Dietary Supplement: vitamin D omega-3
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase 3 Study of Vitamin D and Omega-3 Supplementation to Reduce Risk of Metabolic Syndrome

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Guelph:

Primary Outcome Measures:
  • body weight [ Time Frame: up to 16 weeks ] [ Designated as safety issue: No ]
    body weight will be measured to nearest 0.5 kg weekly


Secondary Outcome Measures:
  • Blood pressure [ Time Frame: up to 16 weeks ] [ Designated as safety issue: No ]
    systolic and diastolic blood pressure will be measured in duplicate, weekly

  • Blood lipids [ Time Frame: up to 16 weeks ] [ Designated as safety issue: No ]
    blood lipids will be measured at baseline and after study completion.

  • Glucose homeostasis [ Time Frame: up to 16 weeks ] [ Designated as safety issue: No ]
    fasting blood glucose, insulin, HbA1c, CRP, cytokines and inflammatory markers will be measured at weeks 0 and 16 of the intervention.


Estimated Enrollment: 40
Study Start Date: April 2011
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: diet only
low glycemic index diet, calorie restricted with exercise 3 times per week.
 Other: low glycemic diet
a low glycemic diet, calorie restricted with exercise sessions 3 times per week
Active Comparator: supplemented
2000 IU vitamin D3 plus 1.8 g EPA + DHA
 Other: low glycemic diet
a low glycemic diet, calorie restricted with exercise sessions 3 times per week
Dietary Supplement: vitamin D omega-3
2000 IU vitamin D3 plus 1.8 g EPA + DHA per day for 16 weeks.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01326442

Locations
Canada, Ontario
University of Guelph
Guelph, Ontario, Canada, N1G2W1
Sponsors and Collaborators
University of Guelph
Investigators
Principal Investigator: Kelly A Meckling, PhD University of Guelph
  More Information

No publications provided

Responsible Party: Dr. Kelly Anne Meckling, PhD, Professor, University of Guelph
ClinicalTrials.gov Identifier: NCT01326442     History of Changes
Other Study ID Numbers: 2011MeckVitD
Study First Received: March 29, 2011
Last Updated: March 22, 2012
Health Authority: Canada: Health Canada

Keywords provided by University of Guelph:
weight loss
overweight
body composition
visceral obesity
 insulin
glucose tolerance
cholesterol
hypertriglyceridemia

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Hyperlipidemias
Hypertension
Obesity
Metabolic Syndrome X
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Dyslipidemias
Lipid Metabolism Disorders
Vascular Diseases
Cardiovascular Diseases
Overnutrition
 Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Insulin Resistance
Hyperinsulinism
Vitamin D
Ergocalciferols
Vitamins
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on May 19, 2013