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

Last updated: June 23, 2025
Sponsor: Industrial Farmacéutica Cantabria, S.A.
Overall Status: Active - Recruiting

Phase

N/A

Condition

High Cholesterol (Hyperlipidemia)

Metabolic Disorders

Diabetes Prevention

Treatment

Placebo

AM3

AM3 + Probiotic

Clinical Study ID

NCT06158152
P20110a
  • Ages 18-75
  • All Genders

Study 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 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.

Eligibility Criteria

Inclusion

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 bloodglucose by ≥100 mg/dl, glycosylated hemoglobin between 5.7 and 6.4%, low HDLcholesterol levels < 40 mg/dl in men and < 50 mg/dl in women, and high levels oftriglycerides, being higher than 150 mg/dl.

  3. If the patient is being treated with metformin, lipid-lowering treatment withstatins or treatment with antihypertensives, he/she must have a stable dose at thetime of inclusion.

Exclusion

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 toinvestigator's criteria, this might interfere with his/her participation in thestudy.

  5. Diagnosis of chronic diseases that according to investigator's criteria, this mightinterfere 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 PaCO2greater 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 theinvestigator's criteria: chronic obstructive disease, inflammatory bowel disease,intestinal malabsorption syndrome, systemic autoimmune diseases, rheumatoidarthritis, spondyloarthritis, psoriasis, and chronic inflammatory skin diseases.

  10. Active or chronic severe unstable infections that, in medical criteria, mayinterfere with patients' safety.

  11. Disease-related malnutrition.

  12. Endocrinologic unestable or uncontrolled diseases that in medical criteria, presentwith 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.

Study Design

Total Participants: 48
Treatment Group(s): 3
Primary Treatment: Placebo
Phase:
Study Start date:
May 20, 2024
Estimated Completion Date:
March 01, 2026

Study 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-inflammatory and metabolic status against metabolic syndrome.

The secondary objectives are:

  1. To determine the efficacy of the administration of a new food supplement for MS through the improvement of biochemical variables.

  2. To evaluate the efficacy of the administration of a new dietary supplement on the impact on body composition parameters.

  3. To evaluate the patient's quality of life.

Adult subjects (aged between 18 and 75 years) will randomly be assigned into one of these three treatment groups:

  • Active: patients who will receive the study treatment, consisting of the combination of AM3 and the probiotic SynBalance Metsyn.

  • Placebo: patients who will receive placebo (starch capsules), with no active ingredient.

  • Control: patients to be treated with AM3 capsules alone (no probiotics).

Interventions performed at time 0 and 12 weeks, are carried out to measure parameters such as the following: body composition data (weight, BMI), blood pressure, fasting glucose and insulin levels, monocyte and NK-cell populations, liver enzyme levels, urine sediment, etc.

Finally, a subjective questionnaire is used to evaluate the patients' quality of life before and after treatment.

Connect with a study center

  • Hospital Universitario Infanta Leonor

    Madrid,
    Spain

    Active - Recruiting

  • Hospital Universitario Príncipe de Asturias

    Madrid,
    Spain

    Active - Recruiting

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