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NCT06158152

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

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.
Industrial Farmacéutica Cantabria, S.A.·ClinicalTrials.gov·dietary supplementNot yet recruiting
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Study focus
Disease/Condition
Metabolic Syndrome
Drug/Device/Intervention
AM3 + Probiotic
Study type
Interventional
Intervention type
dietary supplement
Sponsor & location
Primary sponsor
Industrial Farmacéutica Cantabria, S.A.
Timeline & enrollment
Phase
N/A
Start date
Jan 20, 2024
End date
Dec 01, 2024
Enrollment
48 participants
Primary outcome

Change in serum cytokines.

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.

ICD-10 classifications
Metabolic disordersMetabolic disorder, unspecifiedOther metabolic disordersOther specified metabolic disordersNutritional and metabolic disorders in diseases classified elsewhere
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06158152
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT06158152 through Pure Global AI's free database. This phase not specified trial is sponsored by Industrial Farmacéutica Cantabria, S.A. and is currently Not yet recruiting. The study focuses on Metabolic Syndrome. Target enrollment is 48 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.