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Vitamin D and Omega-3 Inhibit Metabolic Syndrome

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01326442
First Posted: March 30, 2011
Last Update Posted: June 13, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Kelly Anne Meckling, PhD, University of Guelph
  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
Intervention Model: Parallel Assignment
Masking: None (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:


Further study details as provided by Kelly Anne Meckling, PhD, University of Guelph:

Primary Outcome Measures:
  • body weight [ Time Frame: up to 16 weeks ]
    body weight will be measured to nearest 0.5 kg weekly


Secondary Outcome Measures:
  • Blood pressure [ Time Frame: up to 16 weeks ]
    systolic and diastolic blood pressure will be measured in duplicate, weekly

  • Blood lipids [ Time Frame: up to 16 weeks ]
    blood lipids will be measured at baseline and after study completion.

  • Glucose homeostasis [ Time Frame: up to 16 weeks ]
    fasting blood glucose, insulin, HbA1c, CRP, cytokines and inflammatory markers will be measured at weeks 0 and 16 of the intervention.


Enrollment: 40
Study Start Date: April 2011
Study Completion Date: December 2012
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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Kelly Anne Meckling, PhD, Professor, University of Guelph
ClinicalTrials.gov Identifier: NCT01326442     History of Changes
Other Study ID Numbers: 2011MeckVitD
First Submitted: March 29, 2011
First Posted: March 30, 2011
Last Update Posted: June 13, 2013
Last Verified: June 2013

Keywords provided by Kelly Anne Meckling, PhD, 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
Metabolic Syndrome X
Hyperlipidemias
Hyperlipoproteinemias
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin Resistance
Hyperinsulinism
Dyslipidemias
Lipid Metabolism Disorders
Vitamins
Vitamin D
Ergocalciferols
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents