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

Launched by INDUSTRIAL FARMACÉUTICA CANTABRIA, S.A. · Nov 27, 2023

Keywords

ClinConnect Summary

This clinical trial is exploring how a nutritional supplement called AM3, combined with probiotics, can affect people with metabolic syndrome. Metabolic syndrome is a condition that includes several risk factors, such as obesity, high blood sugar, and unhealthy cholesterol levels, which can increase the risk of serious health issues. The researchers want to see if taking this supplement daily for 12 weeks can help reduce these risk factors and improve overall health.

To participate in the study, you need to be between 18 and 65 years old and have a diagnosis of metabolic syndrome based on specific health criteria. The trial will involve 48 participants who will be divided into three groups: one receiving the AM3 supplement, another receiving a placebo (a dummy pill), and a control group. Participants will take two capsules each morning and will come in for two visits: one at the beginning and another after 12 weeks. It's important to note that certain health conditions and treatments may exclude individuals from participating, so discussing eligibility with your healthcare provider is crucial.

Gender

ALL

Eligibility criteria

• 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.