A Pilot Study to Evaluate the Systemic Effect of Oral Supplementation With AM3 in Patients With Metabolic Syndrome.

This is a randomized, double-blind, placebo-controlled, pilot study. The primay objective is to evaluate the systemic effect of this new nutritional supplement with AM3 and probiotics on the immuno-inflammatory and metabolic status against metabolic syndrome.

The secondary objectives are:

• To determine the efficacy of the administration of a new food supplement for MS through the improvement of biochemical variables.
• To evaluate the efficacy of the administration of a new dietary supplement on the impact on body composition parameters.
• To evaluate the patient's quality of life.

Adult subjects (aged between 18 and 75 years) will randomly be assigned into one of these three treatment groups:

• Active: patients who will receive the study treatment, consisting of the combination of AM3 and the probiotic SynBalance Metsyn.
• Placebo: patients who will receive placebo (starch capsules), with no active ingredient.
• Control: patients to be treated with AM3 capsules alone (no probiotics).

Interventions performed at time 0 and 12 weeks, are carried out to measure parameters such as the following: body composition data (weight, BMI), blood pressure, fasting glucose and insulin levels, monocyte and NK-cell populations, liver enzyme levels, urine sediment, etc.

Finally, a subjective questionnaire is used to evaluate the patients' quality of life before and after treatment.

Inclusion criteria

• 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.

Exclusion criteria

• 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.
• Diagnosis of chronic diseases that according to investigator's criteria, this might interfere with his/her participation in the study.
• Presence of renal insufficiency (glomerular filtration rate below 30 ml/minute).
• Presence of severe respiratory insufficiency (PaO2 less than 60 mmHg or PaCO2 greater than 50 mmHg).
• Presence of heart failure (LVEF <30% and RVEF <35%).
• 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.
• Active or chronic severe unstable infections that, in medical criteria, may interfere with patients' safety.
• Disease-related malnutrition.
• Endocrinologic unestable or uncontrolled diseases that in medical criteria, present with manifestations in pituitary, adrenal or thyroid function.
• Immunosuppressive or corticosteroid treatment in the last 3 months.
• Treatment with semaglutide and tirzepatide.
• Pregnant women (or intending to become pregnant) or breast-feeding women.