💬In plain words
What the trial is, and whether it could suit you
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 perfor
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
Inclusion Criteria:
1. Men or women aged 18-75 years at the time of signing the informed consent form.
2. 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.
3. 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.
Exclusion Criteria:
1. Smokers or with history of alcoholism or drug abuse .
2. To have hypertriglyceridemia (\> 500 mg/dL).
3. Uncontrolled arterial hypertension, as per investigator's criteria.
4. 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.
5. Diagnosis of chronic diseases that according to investigator's criteria, this might interfere with his/her participation in the study.
6. Presence of renal insufficiency (glomerular filtration rate below 30 ml/minute).
7. Presence of severe respiratory insufficiency (PaO2 less than 60 mmHg or PaCO2 greater than 50 mmHg).
8. Presence of heart failure (LVEF \<30% and RVEF \<35%).
9. Presence of the following diseases in an unstable manner, according to the investigator's criteria: chronic obstructive disease, inflammatory bowel disease, intestinal malabsorption syndrome, systemic autoimmune diseases, rheumatoid arthritis, spondyloarthritis, psoriasis, and chronic inflammatory skin diseases.
10. Active or chronic severe unstable infections that, in medical criteria, may interfere with patients' safety.
11. Disease-related malnutrition.
12. Endocrinologic unestable or uncontrolled diseases that in medical criteria, present with manifestations in pituitary, adrenal or thyroid function.
13. Immunosuppressive or corticosteroid treatment in the last 3 months.
14. Treatment with semaglutide and tirzepatide.
15. Pregnant women (or intending to become pregnant) or breast-feeding women.
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