Evaluating the effects of AM3 and probiotics on metabolic syndrome

A Randomized, Double-blind, Placebo-controlled Pilot Study to Evaluate the Systemic Effect on Immunoinflammatory and Metabolic Status of an Oral Supplementation With AM3 in Patients With Metabolic Syndrome.

This study is testing whether a nutritional supplement with AM3 and probiotics can improve health markers and quality of life for adults with metabolic syndrome.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 48 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Industrial Farmacéutica Cantabria, S.A. (Industry-sponsored)
• Locations: 2 sites (Madrid and 1 other locations)
• Trial ID: NCT06158152 on ClinicalTrials.gov

What this trial studies

This pilot study aims to assess the impact of a nutritional supplement combining AM3 and probiotics on inflammatory and metabolic markers in adults diagnosed with metabolic syndrome. A total of 48 participants will be randomized into three groups: one receiving the active supplement, one receiving a placebo, and one receiving AM3 alone. The study will measure various health parameters, including body composition, blood pressure, and biochemical variables, at baseline and after 12 weeks of treatment. Additionally, participants' quality of life will be evaluated through subjective questionnaires.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-65 with a diagnosis of metabolic syndrome.

Not a fit: Patients with uncontrolled hypertension or those currently using metformin or other conflicting treatments may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a novel dietary intervention to help manage metabolic syndrome and reduce associated health risks.

How similar studies have performed: While there is ongoing research in this area, the specific combination of AM3 and probiotics in this context is relatively novel and has not been extensively tested.

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.

Where this trial is running

Madrid and 1 other locations

• Hospital Universitario Infanta Leonor — Madrid, Spain (Recruiting)
• Hospital Universitario Príncipe de Asturias — Madrid, Spain (Recruiting)

Study contacts

• Principal investigator: Julia Álvarez — Servicio de Endocrinología y Nutrición del Hospital Universitario Príncipe de Asturias de Alcalá de Henares (Madrid)
• Study coordinator: Ana López-Ballesteros

Conditions Metabolic Syndrome; AM3; Probiotics; Inmunoferon; Food suplement; Immune response