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 endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from

For full trial details, please see the original record at

Registration number
Ethics application status
Date submitted
Date registered
Date last updated

Titles & IDs
Public title
The Effect of a Nutritional Supplement in Individuals With Type 2 Diabetes Mellitus: a Pilot Study
Scientific title
The Effect of a Nutritional Supplement on Cardiometabolic, Inflammatory, and Oxidative Stress Markers in Individuals With Type 2 Diabetes Mellitus: a Pilot Study
Secondary ID [1] 0 0
HREC 12392
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetes Mellitus, Type 2 0 0
Insulin Resistance 0 0
Condition category
Condition code
Metabolic and Endocrine 0 0 0 0

Study type
Description of intervention(s) / exposure
Other interventions - Zinc supplements
Other interventions - Omega 3 supplements
Other interventions - Placebo supplements

Active Comparator: Zinc supplement -

Active Comparator: Omega 3 supplement -

Active Comparator: Zinc and omega 3 supplements -

Placebo Comparator: Placebo supplement -

Other interventions: Zinc supplements
Participants will receive 40 mg of zinc each day for 12 weeks.

Other interventions: Omega 3 supplements
Participants will receive 2 g of omega 3 fatty acids each day for 12 weeks.

Other interventions: Placebo supplements
Participants will receive placebo supplements each day for 12 weeks.

Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Primary outcome [1] 0 0
Plasma lipids (total cholesterol, HDL cholesterol, LDL cholesterol, triglycerides)
Timepoint [1] 0 0
12 weeks
Primary outcome [2] 0 0
Glycaemic control (glucose, insulin, HbA1c)
Timepoint [2] 0 0
12 weeks
Primary outcome [3] 0 0
Inflammation & oxidative stress (CRP, TNF-a, IL-1, IL-2, IL-6, IL-10 F2 isoprostanes, NF-?B, MPO, other)
Timepoint [3] 0 0
12 weeks
Secondary outcome [1] 0 0
Zinc transporter mRNA expression in peripheral blood mononuclear cells
Timepoint [1] 0 0
12 weeks
Secondary outcome [2] 0 0
Plasma zinc
Timepoint [2] 0 0
12 weeks
Secondary outcome [3] 0 0
Plasma fatty acids
Timepoint [3] 0 0
12 weeks

Key inclusion criteria
- Female, postmenopausal

- Type 2 diabetes (controlled by diet and lifestyle; or oral hypoglycaemic medication
(i.e. metformin) for not more than 7 years)

- Normal Glomerular Filtration Rate (GFR) and normal microalbumin/creatine ratio

- No nutritional supplements in the 6 weeks prior to the trial & continuing through the
trial period

- Non-smoking
Minimum age
48 Years
Maximum age
No limit
Can healthy volunteers participate?
Key exclusion criteria
- Diagnosed with current major illness (renal disease, significant cardiovascular
disease, gastrointestinal disorders, cancer, or other significant disorder likely to
interfere with zinc metabolism)

- Taking medications that are likely to interfere with zinc metabolism

Study design
Purpose of the study
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Other design features
Phase 1
Type of endpoint(s)
Statistical methods / analysis

Recruitment status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
University of Sydney - Sydney
Recruitment postcode(s) [1] 0 0
2006 - Sydney

Funding & Sponsors
Primary sponsor type
University of Sydney

Ethics approval
Ethics application status

Brief 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.
Trial website
Trial related presentations / publications
Foster M, Petocz P, Samman S. Effects of zinc on plasma lipoprotein cholesterol concentrations in humans: a meta-analysis of randomised controlled trials. Atherosclerosis. 2010 Jun;210(2):344-52. doi: 10.1016/j.atherosclerosis.2009.11.038. Epub 2009 Nov 29.
Foster M, Samman S. Zinc and redox signaling: perturbations associated with cardiovascular disease and diabetes mellitus. Antioxid Redox Signal. 2010 Nov 15;13(10):1549-73. doi: 10.1089/ars.2010.3111. Review.
Foster M, Hancock D, Petocz P, Samman S. Zinc transporter genes are coordinately expressed in men and women independently of dietary or plasma zinc. J Nutr. 2011 Jun;141(6):1195-201. doi: 10.3945/jn.111.140053. Epub 2011 Apr 13.
Public notes

Principal investigator
Name 0 0
Samir Samman
Address 0 0
University of Sydney
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications