Actively Recruiting
A Pilot Study to Evaluate the Systemic Effect of Oral Supplementation With AM3 in Patients With Metabolic Syndrome.
Led by Industrial Farmacéutica Cantabria, S.A. · Updated on 2025-06-26
48
Participants Needed
2
Research Sites
92 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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 performed: at baseline and at week 12.
CONDITIONS
Official Title
A Pilot Study to Evaluate the Systemic Effect of Oral Supplementation With AM3 in Patients With Metabolic Syndrome.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men or women aged 18 to 75 years at the time of signing informed consent
- Diagnosis of metabolic syndrome with central obesity, elevated blood glucose (≥100 mg/dl), glycosylated hemoglobin 5.7-6.4%, low HDL cholesterol (<40 mg/dl men, <50 mg/dl women), and high triglycerides (>150 mg/dl)
- Stable dose of metformin, statins, or antihypertensives if currently treated with these medications
You will not qualify if you...
- Current smokers or those with history of alcoholism or drug abuse
- Hypertriglyceridemia greater than 500 mg/dL
- Uncontrolled arterial hypertension as per investigator's criteria
- Bariatric surgery within last 24 months that may interfere with study participation
- Chronic diseases or conditions interfering with study participation as judged by investigator
- Renal insufficiency with glomerular filtration rate below 30 ml/min
- Severe respiratory insufficiency (PaO2 < 60 mmHg or PaCO2 > 50 mmHg)
- Heart failure with LVEF < 30% and RVEF < 35%
- Unstable chronic inflammatory or autoimmune diseases including COPD, inflammatory bowel disease, malabsorption syndrome, rheumatoid arthritis, spondyloarthritis, psoriasis, or chronic inflammatory skin diseases
- Active or chronic severe unstable infections affecting safety
- Disease-related malnutrition
- Unstable or uncontrolled endocrine diseases affecting pituitary, adrenal, or thyroid function
- Use of immunosuppressive or corticosteroid treatment in the last 3 months
- Treatment with semaglutide or tirzepatide
- Pregnant, breastfeeding, or intending to become pregnant women
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Hospital Universitario Infanta Leonor
Madrid, Spain
Actively Recruiting
2
Hospital Universitario Príncipe de Asturias
Madrid, Spain
Actively Recruiting
Research Team
A
Ana López-Ballesteros
CONTACT
M
Mencía Hermosa-Vicente
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
3
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