The goal of this pilot study is to learn about the effect of the nutritional supplementation based on AM3 in combination with probiotics on imflammatory and metabolic mediators in adult subjects diagnosed with metabolic syndrome.
The hypothesis the investigators are testing focuses on the fact that the continued use of the nutritional supplement with AM3 and probiotics is capable of minimizing the risk factors associated with metabolic syndrome, by reducing the development of the derived chronic pathologies.
A total of 48 subjects with a diagnosis of metabolic syndrome is planned to be recruited from two investigational sites in the Comunity of Madrid (Spain). These subjects will be randomized into three treatment groups (active, placebo, and control). The dosage will be of 2 capsules/day in a single intake in the morning for 12 weeks. Two interventional visits are planned to be performed: at baseline and at week 12.
Men or women aged 18-75 years at the time of signing the informed consent form.
Diagnosis of metabolic syndrome, defined as: central obesity, elevation of blood glucose by ≥100 mg/dl, glycosylated hemoglobin between 5.7 and 6.4%, low HDL cholesterol levels < 40 mg/dl in men and < 50 mg/dl in women, and high levels of triglycerides, being higher than 150 mg/dl.
If the patient is being treated with metformin, lipid-lowering treatment with statins or treatment with antihypertensives, he/she must have a stable dose at the time of inclusion.
Smokers or with history of alcoholism or drug abuse .
To have hypertriglyceridemia (> 500 mg/dL).
Uncontrolled arterial hypertension, as per investigator's criteria.
To have undergone bariatric surgery over the last 24 months that according to investigator's criteria, this might interfere with his/her participation in the study.
Parallel
AM3 + Probiotic
Dietary supplementTwo capsules daily in the morning during 12 weeks. The capsule contains the mixture of AM3 Technology and probiotic SynBalance Metsyn.
Placebo
Dietary supplementTwo capsules daily in the morning during 12 weeks. The capsule contains starch.
AM3
Dietary supplementTwo capsules daily in the morning during 12 weeks. The capsule contains AM3 Technology.
Change in serum cytokines.
Circulating cytokine levels will be determined at baseline and at week 12 to assess the effect on inflammatory mediators.
Change in monocytes and natural killer cells levels.
Serum monocytes and natural killers cells will be determined at baseline and week 12 to assess the effect on inflammatory status and oxidative stress.
Change in serum uric acid.
Uric acid will be analized to assess the effect on inflammatory and metabolic mediators. These results will be displayed in the results data table.
Change in serum sodium.
sodium will be analized to assess the effect on inflammatory and metabolic mediators. These results will be displayed in the results data table.
Change in serum potasium.
potassium will be analized to assess the effect on inflammatory and metabolic mediators. These results will be displayed in the results data table.
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