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RECRUITING
NCT06158152
NA

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

Sponsor: Industrial Farmacéutica Cantabria, S.A.

View on ClinicalTrials.gov

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.

Official title: 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.

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

48

Start Date

2024-05-20

Completion Date

2026-03-01

Last Updated

2025-06-26

Healthy Volunteers

No

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.

Locations (2)

Hospital Universitario Infanta Leonor

Madrid, Spain

Hospital Universitario Príncipe de Asturias

Madrid, Spain