A Pilot Study to Evaluate the Systemic Effect of Oral Supplementation With AM3 in Patients With Metabolic Syndrome. - Trial NCT06158152
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.
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Study Focus
Sponsor & Location
Industrial Farmacéutica Cantabria, S.A.
Timeline & Enrollment
N/A
Jan 20, 2024
Dec 01, 2024
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
Data Source
ClinicalTrials.gov
NCT06158152
Non-Device Trial