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Completed

NCT Number: NCT01326442

Vitamin D and Omega-3 Inhibit Metabolic Syndrome

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.

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Key information

Conditions

Type 2 Diabetes Mellitus Body Weight Body Weight Changes Cardiovascular Diseases Diabetes Mellitus Diabetes Mellitus, Type 2 Dyslipidemias Endocrine System Diseases Glucose Metabolism Disorders Hyperinsulinism Hyperlipidemia Hyperlipidemias Hypertension Hypertriglyceridemia Insulin Resistance Lipid Metabolism Disorders Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Obesity, Abdominal Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Vascular Diseases Weight Loss

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University of Guelph

Guelph, Ontario, N1G2W1, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Low glycemic diet

Other

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

vitamin D omega-3

Dietary Supplement

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

Primary outcomes

  1. body weight

    Time frame: up to 16 weeks

    body weight will be measured to nearest 0.5 kg weekly

Secondary outcomes

  1. Blood pressure

    Time frame: up to 16 weeks

    systolic and diastolic blood pressure will be measured in duplicate, weekly

  2. Blood lipids

    Time frame: up to 16 weeks

    blood lipids will be measured at baseline and after study completion.

  3. 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.

Sponsors and collaborators

Lead sponsor

University of Guelph

Other

Registry information

Official study title

Phase 3 Study of Vitamin D and Omega-3 Supplementation to Reduce Risk of Metabolic Syndrome

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Mar 30, 2011
Registry last updated
Jun 13, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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