Status:
RECRUITING
A Pilot Study to Evaluate the Systemic Effect of Oral Supplementation With AM3 in Patients With Metabolic Syndrome.
Lead Sponsor:
Industrial Farmacéutica Cantabria, S.A.
Conditions:
Metabolic Syndrome
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
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 diagn...
Detailed Description
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-in...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 20 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2026
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT06158152
Start Date
May 20 2024
End Date
March 1 2026
Last Update
June 26 2025
Active Locations (2)
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1
Hospital Universitario Infanta Leonor
Madrid, Spain
2
Hospital Universitario Príncipe de Asturias
Madrid, Spain