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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/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
Gender
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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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/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. 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

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

Summary results
Other publications