None listed
Conditions
Brief summary
Metabolic syndrome (MetS) is a cluster of conditions that, when occurring together, increase the risk of heart disease, stroke and type-2 diabetes. These conditions include hypertension (high blood pressure), insulin resistance (high blood sugar), excess fat around the waist, and elevated cholesterol or triglyceride levels. Inflammation is believed to be a major driver of MetS, and those with the condition often show increased levels of inflammatory markers in their blood, such as C-reactive protein (CRP), which is a known risk factor for cardiovascular diseases. As such, there is a growing interest in using anti-inflammatory agents to potentially slow and/or prevent progression of MetS to the more severe diseases such as type 2 diabetes and cardiovascular disease. Vitamin C is a potent antioxidant with anti-inflammatory properties. Research has shown that people with MetS have lower vitamin C levels than those without, and higher vitamin C levels have been associated with a lower risk of MetS. Vitamin C can also improve markers of metabolic health, such a blood sugar control and lipid profiles, including cholesterol and triglycerides. Humans cannot produce vitamin C endogenously, therefore, we must obtain it through our diet. The aim of this study is to determine whether vitamin C plus micronutrient supplementation of people with MetS and elevated inflammation results in decreased markers of inflammation. We will undertake a 12 week randomised controlled trial (1 daily effervescent micronutrient tablet or placebo) in a group of volunteers with MetS. We will measure a number of blood and urine markers of inflammation, glycaemic measures, lipid measures, anthropomorphic measures, and subjective mood/fatigue at clinic visits at baseline and weeks 6 and 12.
Interventions
The intervention is an everyday oral micronutrient tablet (Bayer) which will be administered for 12 weeks.
Dose: 1 effervescent tablet
Route: dissolved in water for oral consumption
Frequency: once per day
Composition: 1000 mg vitamin C, 10 ug vitamin D, 45 mg vitamin E, 700 ug vitamin A, 6.5 mg vitamin B6, 400 ug folate, 9.6 ug vitamin B12, 10 mg zinc, 5 mg iron, 0.9 mg copper, 110 ug selenium
Sponsors
University of Otago, Dunedin
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1 - Male or female aged greater than or equal to 18 years 2 - Central/abdominal obesity (i.e. waist circumference greater than or equal to 94 cm for males, greater than or equal to 80 cm for females or BMI greater than or equal to 30 kg/m2) 3 - And any two of the below: a) Hyperglycemia (i.e. fasting glucose greater than or equal to 5.6 mmol/L or taking medication for this condition) b) Raised triglycerides (i.e. TG greater than or equal to 1.7 mmol/L or taking medication for this condition) c) Lowered HDL (HDL less than 1.0 mmol/L males, less than 1.3 mmol/L females or taking medication for this condition) d) Hypertension (i.e. blood pressure greater than 130 systolic or greater than 86 diastolic or taking medication for this condition) 4 - CRP greater than 3mg/L (i.e. high risk of cardiovascular disease - CVD)
Exclusion criteria
1 - Acute illness within previous 2 weeks 2 - Taking anti-inflammatory medication (e.g. corticosteroids) 3 - Suffering from inflammatory conditions (e.g. active malignancy, rheumatoid arthritis, lupus, inflammatory bowel disease) 4 - Pregnant or breastfeeding 5 - Taking micronutrient (vitamin/mineral) supplements
Outcome results
None listed