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

June 23, 2025 updated by: Industrial Farmacéutica Cantabria, S.A.

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.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
48

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Spain
      • Madrid, Spain
        • Recruiting
        • Hospital Universitario Infanta Leonor
        • Contact:
          • Cristina Sevillano
        • Contact:
          • María Llavero
      • Madrid, Spain
        • Recruiting
        • Hospital Universitario Príncipe de Asturias
        • Contact:
          • Julia Álvarez

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Men or women aged 18-75 years at the time of signing the informed consent form.
  2. Diagnosis of metabolic syndrome, defined as: central obesity, elevation of blood glucose by ≥100 mg/dl, glycosylated hemoglobin between 5.7 and 6.4%, low HDL cholesterol levels < 40 mg/dl in men and < 50 mg/dl in women, and high levels of triglycerides, being higher than 150 mg/dl.
  3. If the patient is being treated with metformin, lipid-lowering treatment with statins or treatment with antihypertensives, he/she must have a stable dose at the time of inclusion.

Exclusion Criteria:

  1. Smokers or with history of alcoholism or drug abuse .
  2. To have hypertriglyceridemia (> 500 mg/dL).
  3. Uncontrolled arterial hypertension, as per investigator's criteria.
  4. To have undergone bariatric surgery over the last 24 months that according to investigator's criteria, this might interfere with his/her participation in the study.
  5. Diagnosis of chronic diseases that according to investigator's criteria, this might interfere with his/her participation in the study.
  6. Presence of renal insufficiency (glomerular filtration rate below 30 ml/minute).
  7. Presence of severe respiratory insufficiency (PaO2 less than 60 mmHg or PaCO2 greater than 50 mmHg).
  8. Presence of heart failure (LVEF <30% and RVEF <35%).
  9. Presence of the following diseases in an unstable manner, according to the investigator's criteria: chronic obstructive disease, inflammatory bowel disease, intestinal malabsorption syndrome, systemic autoimmune diseases, rheumatoid arthritis, spondyloarthritis, psoriasis, and chronic inflammatory skin diseases.
  10. Active or chronic severe unstable infections that, in medical criteria, may interfere with patients' safety.
  11. Disease-related malnutrition.
  12. Endocrinologic unestable or uncontrolled diseases that in medical criteria, present with manifestations in pituitary, adrenal or thyroid function.
  13. Immunosuppressive or corticosteroid treatment in the last 3 months.
  14. Treatment with semaglutide and tirzepatide.
  15. Pregnant women (or intending to become pregnant) or breast-feeding women.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Active arm
Patients who will receive the study treatment (AM3 Technology in combination with Probiotic SynBalance Metsyn)
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.
Placebo Comparator: Placebo arm
Patients who will receive placebo treatment, consisting of starch capsules
Dietary supplement: Placebo
Two capsules daily in the morning during 12 weeks. The capsule contains starch.
Sham Comparator: Control arm
Patients to be treated with AM3 Technology capsules
Dietary supplement: AM3
Two capsules daily in the morning during 12 weeks. The capsule contains AM3 Technology.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in serum cytokines.
Time Frame: Baseline and week 12
Circulating cytokine levels will be determined at baseline and at week 12 to assess the effect on inflammatory mediators.
Baseline and week 12

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in monocytes and natural killer cells levels.
Time Frame: Baseline and week 12
Serum monocytes and natural killers cells will be determined at baseline and week 12 to assess the effect on inflammatory status and oxidative stress.
Baseline and week 12
Change in serum uric acid.
Time Frame: Baseline and week 12
Uric acid will be analized to assess the effect on inflammatory and metabolic mediators. These results will be displayed in the results data table.
Baseline and week 12
Change in serum sodium.
Time Frame: Baseline and week 12
sodium will be analized to assess the effect on inflammatory and metabolic mediators. These results will be displayed in the results data table.
Baseline and week 12
Change in serum potasium.
Time Frame: Baseline and week 12
potassium will be analized to assess the effect on inflammatory and metabolic mediators. These results will be displayed in the results data table.
Baseline and week 12
Change in serum bilirrubin.
Time Frame: Baseline and week 12
Bilirrubin will be analized to assess the effect on inflammatory and metabolic mediators. These results will be displayed in the results data table.
Baseline and week 12
Change in serum lipids
Time Frame: Baseline and week 12
Serum lipids will be determined at baseline and at week 12 to assess the effect on metabolic parameters.
Baseline and week 12
Change in serum glucose
Time Frame: Baseline and week 12
Fasting blood glucose levels will be analized to assess the effect on inflammatory and metabolic mediators.
Baseline and week 12
Change in blood pressure
Time Frame: Baseline and week 12.
Blood pressure (Diastolic and systolic) [mmHg] will be determined at baseline and after 12 weeks of study treatment.
Baseline and week 12.
Change in waist circumference
Time Frame: Baseline and week 12
Waist circumference [cm] will be obtained at baseline and at week 12 to assess the efficacy on body composition.
Baseline and week 12
Change in hip circumference
Time Frame: Baseline and week 12
Hip circumference [cm] will be obtained at baseline and at week 12 to assess the efficacy on body composition.
Baseline and week 12
Change in weight
Time Frame: Baseline and week 12
Weight [Kg] will be obtained at baseline and at week 12 to assess the efficacy on body composition. These results will be displayed in the results data table.
Baseline and week 12
Change in body mass index
Time Frame: Baseline and week 12
BMI [Kg/m2] will be obtained at baseline and at week 12 to assess the efficacy on body composition. These results will be displayed in the results data table.
Baseline and week 12
Change in total body fat content
Time Frame: Baseline and week 12
Total body fat content will be measured at baseline and at week 12 using electrical bioimpedance.
Baseline and week 12
Change in patient's quality of life, assessed by the SF-12v2 score.
Time Frame: Baseline and week 12

This is a health-related quality-of-life questionnaire, consisting of 12 questions that measure eight health domains to assess physical and mental health. Physical health-related domains include General Health (GH), Physical Functioning (PF), Role Physical (RP), and Body Pain (BP). This score will be determined at baseline and at week 12.

Scores range from 0 to 100, with higher scores indicating better physical and mental health functioning.
Baseline and week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Industrial Farmacéutica Cantabria, S.A.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Julia Álvarez, Servicio de Endocrinología y Nutrición del Hospital Universitario Príncipe de Asturias de Alcalá de Henares (Madrid)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 20, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 26, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 27, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 6, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 26, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 23, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • P20110a

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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