Vitamin D and Omega-3 Inhibit Metabolic Syndrome

NCT01326442 | Completed Phase 3 DMC

• 1 other identifier: 2011MeckVitD
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes Mellitus; Hypertension; Hyperlipidemia; Obesity

Keywords

weight loss; overweight; body composition; visceral obesity; insulin; glucose tolerance; cholesterol; hypertriglyceridemia

Outcome Measures

Primary Outcomes (1)

• body weight

  body weight will be measured to nearest 0.5 kg weekly

  up to 16 weeks

Secondary Outcomes (3)

• Blood pressure

  up to 16 weeks

• Blood lipids

  up to 16 weeks

• Glucose homeostasis

  up to 16 weeks

Study Arms (2)

diet only

EXPERIMENTAL

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

Other: low glycemic diet

supplemented

ACTIVE COMPARATOR

2000 IU vitamin D3 plus 1.8 g EPA + DHA

Other: low glycemic diet; Dietary Supplement: vitamin D omega-3

Interventions

low glycemic diet OTHER

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

diet only; supplemented

vitamin D omega-3 DIETARY_SUPPLEMENT

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

supplemented

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• pregnant or lactating
• vegetarian

Sponsors & Collaborators

• University of Guelph: lead

Study Sites (1)

University of Guelph

Guelph, Ontario, N1G2W1, Canada

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Hypertension; Hyperlipidemias; Obesity; Weight Loss; Overweight; Obesity, Abdominal; Insulin Resistance; Hypertriglyceridemia

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases; Dyslipidemias; Lipid Metabolism Disorders; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes; Hyperinsulinism

Study Officials

• Kelly A Meckling, PhD

  University of Guelph

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 29, 2011
• First Posted: March 30, 2011
• Study Start: April 1, 2011
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: June 13, 2013

Record last verified: 2013-06

Locations

CA (1)