Actively Recruiting

Phase Not Applicable
Age: 18Years - 75Years
All Genders
ID06158152

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

Led by Industrial Farmacéutica Cantabria, S.A. · Updated on 2025-06-26

48

Participants Needed

2

Research Sites

17 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying the effects of a nutritional supplement combining AM3 technology and probiotics on adults diagnosed with metabolic syndrome. This pilot study aims to understand how this supplementation influences inflammatory and metabolic factors that contribute to chronic conditions linked to metabolic syndrome. A total of 48 participants aged 18 to 75 years with metabolic syndrome will be enrolled and randomly assigned to different treatment groups. Participants are divided into three groups: one receiving AM3 combined with the probiotic SynBalance Metsyn, one receiving a placebo of starch capsules, and one receiving AM3 capsules alone without probiotics. Each participant will take two capsules once daily in the morning for 12 weeks. The study is double-blind and placebo-controlled, with two main visits scheduled at the start and at the end of the 12-week treatment period. During the study, researchers will collect various health measurements including body composition (weight, BMI), blood pressure, blood glucose, insulin levels, immune cell populations, liver enzymes, and urine analysis. Participants will also complete quality of life questionnaires before and after treatment. The primary outcome is the change in serum cytokines measured at baseline and week 12. Secondary outcomes include changes in metabolic markers, body measurements, and quality of life. The study follows participants for 12 weeks of treatment from baseline to final evaluation.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Men or women aged 18 to 75 years at the time of signing the informed consent form
  • Diagnosis of metabolic syndrome defined by central obesity, elevated blood glucose (≥100 mg/dl), glycosylated hemoglobin between 5.7 and 6.4%, low HDL cholesterol (<40 mg/dl in men, <50 mg/dl in women), and high triglycerides (>150 mg/dl)
  • Stable dose of metformin, statins, or antihypertensive treatment if currently treated with these medications
Not Eligible

You will not qualify if you...

  • Current smokers or history of alcoholism or drug abuse
  • Hypertriglyceridemia (>500 mg/dL)
  • Uncontrolled arterial hypertension
  • Bariatric surgery within the last 24 months if it may interfere with study participation
  • Chronic diseases that may interfere with participation
  • Renal insufficiency (glomerular filtration rate below 30 ml/min)
  • Severe respiratory insufficiency (PaO2 < 60 mmHg or PaCO2 > 50 mmHg)
  • Heart failure (LVEF <30% and RVEF <35%)
  • Unstable chronic obstructive disease, inflammatory bowel disease, malabsorption syndromes, systemic autoimmune diseases, rheumatoid arthritis, spondyloarthritis, psoriasis, or chronic inflammatory skin diseases
  • Active or severe unstable infections
  • Disease-related malnutrition
  • Unstable or uncontrolled endocrinologic diseases affecting pituitary, adrenal, or thyroid function
  • Immunosuppressive or corticosteroid treatment in the last 3 months
  • Treatment with semaglutide or tirzepatide
  • Pregnant or breastfeeding women

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 12 weeks

Participants take two capsules daily in the morning for 12 weeks. Depending on their group, they receive either AM3 with probiotic, AM3 alone, or placebo.

2 visits (baseline and week 12)

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

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Research Team

A

Ana López-Ballesteros

M

Mencía Hermosa-Vicente

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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Published Research Related To This Trial

A new method for radioiodination of polysaccharides and its use in biodistribution studies of an immunomodulating glycoconjugate (Immunoferon).

A Guerrero, A Brieva, J P Pivel

https://pubmed.ncbi.nlm.nih.gov/11256233