Vitamin D and Omega-3 Inhibit Metabolic Syndrome

University of Guelph

Status and phase: Completed; Phase 3

Conditions: Hypertension; Hyperlipidemia; Type 2 Diabetes Mellitus; Obesity

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

Study type: Interventional

Funder types: Other

Identifiers

NCT01326442

2011MeckVitD

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

diet only

Experimental group

Description:

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

Treatment:

Other: low glycemic diet

supplemented

Active Comparator group

Description:

2000 IU vitamin D3 plus 1.8 g EPA + DHA

Treatment:

Other: low glycemic diet

Dietary Supplement: vitamin D omega-3