The Effect of a Nutritional Supplement in Individuals With Type 2 Diabetes Mellitus: a Pilot Study
The Effect of a Nutritional Supplement on Cardiometabolic, Inflammatory, and Oxidative Stress Markers in Individuals With Type 2 Diabetes Mellitus: a Pilot Study
Studie Overzicht
Toestand
Gedetailleerde beschrijving
The prevalence of type 2 DM and related-complications continues to increase. Diet is a significant factor in the aetiology of type 2 DM. Intakes of zinc and omega 3 fatty acids may modulate glycaemic control, lipid metabolism, and inflammatory processes in the disease. Zinc is involved in many biological processes that include enzyme action, stabilisation of cell membranes, regulation of gene expression, and cell signalling. Zinc supplementation has been demonstrated to improve glycaemic control in both animals and humans. The normalising effect of zinc on glucose homeostasis may relate to its involvement in insulin metabolism. Zinc functions in the synthesis, storage, secretion, and action of insulin. Omega-3 also enhances glycaemic control and dietary supplementation with omega-3 polyunsaturated fatty acids has been shown to improve insulin sensitivity in subjects with DM. Both zinc and omega-3 function to mediate lipid metabolism. Zinc supplementation has been found to be associated with a beneficial increase in HDL cholesterol concentrations in individuals with type 2 DM. The mechanism may again involve insulin, which has been proposed as an independent predictor of plasma HDL. Omega-3 directly activates transcription factors that regulate lipid metabolism and is known to decrease serum triglyceride levels in DM. Zinc appears to beneficially impact oxidative stress-related parameters in DM via a range of mechanisms, including the regulation of copper,zinc superoxide dismutase, metallothionein, NF-κB and nitric oxide signaling. The purpose of this pilot study is to explore the effect of zinc and omega 3 supplementation on hyperglycaemia, dyslipidaemia, chronic inflammation, and oxidative stress in a population with type 2 DM.
This study will recruit 48 postmenopausal women with type 2 DM. Participants will be randomly allocated to one of 4 groups for a period of 12 weeks: placebo, zinc, omega 3, or zinc + omega 3 supplementation. Usual dietary intake will be assessed before and after the trial period using 2-day estimated food records, which will be checked by a research dietitian. Blood samples will be collected from all participants at the start of the intervention (week 0) then at 4 weekly intervals (weeks 4, 8, 12) by qualified phlebotomists. Blood samples will be analysed for plasma zinc, plasma lipids and fatty acids, markers of inflammation and oxidative stress, and indicators of glycaemic control. An aliquot of blood will also be used for the measurement of zinc transporter mRNA levels utilising real-time quantitative PCR techniques.
Studietype
Inschrijving (Werkelijk)
Fase
- Fase 1
Contacten en locaties
Studie Locaties
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New South Wales
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Sydney, New South Wales, Australië, 2006
- University of Sydney
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Verdrievoudigen
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Placebo-vergelijker: Placebo-supplement
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Participants will receive placebo supplements each day for 12 weeks.
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Actieve vergelijker: Zinc supplement
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Participants will receive 40 mg of zinc each day for 12 weeks.
Participants will receive placebo supplements each day for 12 weeks.
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Actieve vergelijker: Omega 3 supplement
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Participants will receive placebo supplements each day for 12 weeks.
Participants will receive 2 g of omega 3 fatty acids each day for 12 weeks.
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Actieve vergelijker: Zinc and omega 3 supplements
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Participants will receive 40 mg of zinc each day for 12 weeks.
Participants will receive 2 g of omega 3 fatty acids each day for 12 weeks.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
|---|---|
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Plasma lipids (total cholesterol, HDL cholesterol, LDL cholesterol, triglycerides)
Tijdsspanne: 12 weeks
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12 weeks
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Glycaemic control (glucose, insulin, HbA1c)
Tijdsspanne: 12 weeks
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12 weeks
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Inflammation & oxidative stress (CRP, TNF-α, IL-1, IL-2, IL-6, IL-10 F2 isoprostanes, NF-κB, MPO, other)
Tijdsspanne: 12 weeks
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12 weeks
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Secundaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
|---|---|
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Zinc transporter mRNA expression in peripheral blood mononuclear cells
Tijdsspanne: 12 weeks
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12 weeks
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Plasma zinc
Tijdsspanne: 12 weeks
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12 weeks
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Plasma fatty acids
Tijdsspanne: 12 weeks
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12 weeks
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Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: Samir Samman, University of Sydney
- Hoofdonderzoeker: Meika Foster, University of Sydney
Publicaties en nuttige links
Algemene publicaties
- 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.
Studie record data
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Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
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Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- HREC 12392
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