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

NCT06158152 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2025-06-26

No results posted yet for this 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.

Conditions

  • Metabolic Syndrome

Interventions

DIETARY_SUPPLEMENT

AM3 + Probiotic

Two capsules daily in the morning during 12 weeks. The capsule contains the mixture of AM3 Technology and probiotic SynBalance Metsyn.

DIETARY_SUPPLEMENT

Placebo

Two capsules daily in the morning during 12 weeks. The capsule contains starch.

DIETARY_SUPPLEMENT

AM3

Two capsules daily in the morning during 12 weeks. The capsule contains AM3 Technology.

Sponsors & Collaborators

  • Industrial Farmacéutica Cantabria, S.A.

    lead INDUSTRY

Principal Investigators

  • Julia Álvarez · Servicio de Endocrinología y Nutrición del Hospital Universitario Príncipe de Asturias de Alcalá de Henares (Madrid)

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-05-20
Primary Completion
2025-11-01
Completion
2026-03-01

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06158152 on ClinicalTrials.gov