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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01505803




Registration number
NCT01505803
Ethics application status
Date submitted
25/10/2011
Date registered
9/01/2012
Date last updated
9/01/2012

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
Diabetes

Intervention/exposure
Study type
Interventional
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

Outcomes
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

Eligibility
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
Sex
Females
Can healthy volunteers participate?
No
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
Treatment
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
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/07/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2011
Sample size
Target
Accrual to date
Final
48
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
University of Sydney - Sydney
Recruitment postcode(s) [1] 0 0
2006 - Sydney

Funding & Sponsors
Primary sponsor type
Other
Name
University of Sydney
Address
Country

Ethics approval
Ethics application status

Summary
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
https://clinicaltrials.gov/ct2/show/NCT01505803
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.
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

Contacts
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