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.

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 48 (estimated)
• Sponsor: Industrial Farmacéutica Cantabria, S.A. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Metabolic Syndrome

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-05-20
• Primary completion: 2025-11-01
• Completion: 2026-03-01
• First posted: 2023-12-06
• Last updated: 2025-06-26

Locations

2 sites across 1 country: Spain