MedTrace Logo

The Effect of a Nutritional Supplement in Individuals With Type 2 Diabetes Mellitus: a Pilot Study

NCT01505803 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2012-01-09

No results posted yet for this study

Summary

Diabetes Mellitus (DM) is a major risk factor for cardiovascular disease, with 50% of diabetes-associated deaths being attributed to cardiovascular complications. The characterising features of DM include: the presence of chronic hyperglycaemia, consequent upon decreased secretion or action of insulin; dyslipidaemia; and enhanced levels of oxidative stress and inflammation. Zinc and omega 3 polyunsaturated fatty acids have been shown to influence each of these outcomes via several mechanisms. This pilot study will examine the effect of nutritional supplements containing zinc and omega 3 on these outcomes in a population with type 2 DM.

Conditions

Interventions

DIETARY_SUPPLEMENT

Zinc supplements

Participants will receive 40 mg of zinc each day for 12 weeks.

DIETARY_SUPPLEMENT

Omega 3 supplements

Participants will receive 2 g of omega 3 fatty acids each day for 12 weeks.

DIETARY_SUPPLEMENT

Placebo supplements

Participants will receive placebo supplements each day for 12 weeks.

Sponsors & Collaborators

  • University of Sydney

    lead OTHER

Principal Investigators

  • Samir Samman · University of Sydney

  • Meika Foster · University of Sydney

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
48 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-07-31
Primary Completion
2011-12-31
Completion
2011-12-31

Countries

  • Australia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01505803 on ClinicalTrials.gov