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

NCT06158152 | Recruiting

• 1 other identifier: P20110a
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Metabolic Syndrome

Keywords

Metabolic Syndrome; AM3; Probiotics; Inmunoferon; Food suplement; Immune response

Outcome Measures

Primary Outcomes (1)

• Change in serum cytokines.

  Circulating cytokine levels will be determined at baseline and at week 12 to assess the effect on inflammatory mediators.

  Baseline and week 12

Secondary Outcomes (14)

• Change in monocytes and natural killer cells levels.

  Baseline and week 12

• Change in serum uric acid.

  Baseline and week 12

• Change in serum sodium.

  Baseline and week 12

• Change in serum potasium.

  Baseline and week 12

• Change in serum bilirrubin.

  Baseline and week 12

Study Arms (3)

Active arm

ACTIVE COMPARATOR

Patients who will receive the study treatment (AM3 Technology in combination with Probiotic SynBalance Metsyn)

Dietary Supplement: AM3 + Probiotic

Placebo arm

PLACEBO COMPARATOR

Patients who will receive placebo treatment, consisting of starch capsules

Dietary Supplement: Placebo

Control arm

SHAM COMPARATOR

Patients to be treated with AM3 Technology capsules

Dietary Supplement: AM3

Interventions

AM3 + Probiotic DIETARY_SUPPLEMENT

Two capsules daily in the morning during 12 weeks. The capsule contains the mixture of AM3 Technology and probiotic SynBalance Metsyn.

Active arm

Placebo DIETARY_SUPPLEMENT

Two capsules daily in the morning during 12 weeks. The capsule contains starch.

Placebo arm

AM3 DIETARY_SUPPLEMENT

Two capsules daily in the morning during 12 weeks. The capsule contains AM3 Technology.

Control arm

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men or women aged 18-75 years at the time of signing the informed consent form.
• 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.

You may not qualify if:

• Smokers or with history of alcoholism or drug abuse .
• To have hypertriglyceridemia (\> 500 mg/dL).
• Uncontrolled arterial hypertension, as per investigator's criteria.
• 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.
• Diagnosis of chronic diseases that according to investigator's criteria, this might interfere with his/her participation in the study.
• Presence of renal insufficiency (glomerular filtration rate below 30 ml/minute).
• Presence of severe respiratory insufficiency (PaO2 less than 60 mmHg or PaCO2 greater than 50 mmHg).
• Presence of heart failure (LVEF \<30% and RVEF \<35%).
• 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.
• Active or chronic severe unstable infections that, in medical criteria, may interfere with patients' safety.
• Disease-related malnutrition.
• Endocrinologic unestable or uncontrolled diseases that in medical criteria, present with manifestations in pituitary, adrenal or thyroid function.
• Immunosuppressive or corticosteroid treatment in the last 3 months.
• Treatment with semaglutide and tirzepatide.
• Pregnant women (or intending to become pregnant) or breast-feeding women.

Sponsors & Collaborators

• Industrial Farmacéutica Cantabria, S.A.: lead

Study Sites (2)

Hospital Universitario Infanta Leonor

Madrid, Spain

RECRUITING

Hospital Universitario Príncipe de Asturias

Madrid, Spain

RECRUITING

Related Publications (25)

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• Guerrero A, Brieva A, Pivel JP. A new method for radioiodination of polysaccharides and its use in biodistribution studies of an immunomodulating glycoconjugate (Immunoferon). Methods Find Exp Clin Pharmacol. 2000 Oct;22(8):621-5. doi: 10.1358/mf.2000.22.8.802273.

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• Varela J, Navarro Pico ML, Guerrero A, Garcia F, Gimenez Gallego G, Pivel JP. Identification and characterization of the peptidic component of the immunomodulatory glycoconjugate Immunoferon. Methods Find Exp Clin Pharmacol. 2002 Oct;24(8):471-80. doi: 10.1358/mf.2002.24.8.705066.

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• Ortega del Alamo P, Rivera Rodriguez T, Sanz Fernandez R. [The effect of AM3 in the resolution of otitis media with effusion (OME) in paediatric patients]. Acta Otorrinolaringol Esp. 2005 Jan;56(1):1-5. doi: 10.1016/s0001-6519(05)78561-7. Spanish.

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• King GL. The role of inflammatory cytokines in diabetes and its complications. J Periodontol. 2008 Aug;79(8 Suppl):1527-34. doi: 10.1902/jop.2008.080246.

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  PMID: 31501536 BACKGROUND

• Remely M, Hippe B, Zanner J, Aumueller E, Brath H, Haslberger AG. Gut Microbiota of Obese, Type 2 Diabetic Individuals is Enriched in Faecalibacterium prausnitzii, Akkermansia muciniphila and Peptostreptococcus anaerobius after Weight Loss. Endocr Metab Immune Disord Drug Targets. 2016;16(2):99-106. doi: 10.2174/1871530316666160831093813.

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• Serrano-Gomez D, Martinez-Nunez RT, Sierra-Filardi E, Izquierdo N, Colmenares M, Pla J, Rivas L, Martinez-Picado J, Jimenez-Barbero J, Alonso-Lebrero JL, Gonzalez S, Corbi AL. AM3 modulates dendritic cell pathogen recognition capabilities by targeting DC-SIGN. Antimicrob Agents Chemother. 2007 Jul;51(7):2313-23. doi: 10.1128/AAC.01289-06. Epub 2007 Apr 23.

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• Prieto A, Reyes E, Bernstein ED, Martinez B, Monserrat J, Izquierdo JL, Callol L, de LUCAS P, Alvarez-Sala R, Alvarez-Sala JL, Villarrubia VG, Alvarez-Mon M. Defective natural killer and phagocytic activities in chronic obstructive pulmonary disease are restored by glycophosphopeptical (inmunoferon). Am J Respir Crit Care Med. 2001 Jun;163(7):1578-83. doi: 10.1164/ajrccm.163.7.2002015.

  PMID: 11401877 BACKGROUND

• Brieva A, Guerrero A, Alonso-Lebrero JL, Pivel JP. Immunoferon, a glycoconjugate of natural origin, inhibits LPS-induced TNF-alpha production and inflammatory responses. Int Immunopharmacol. 2001 Oct;1(11):1979-87. doi: 10.1016/s1567-5769(01)00125-4.

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• Majano P, Alonso-Lebrero JL, Janczyk A, Martin-Vichez S, Molina-Jimenez F, Brieva A, Pivel JP, Gonzalez S, Lopez-Cabrera M, Moreno-Otero R. AM3 inhibits LPS-induced iNOS expression in mice. Int Immunopharmacol. 2005 Jul;5(7-8):1165-70. doi: 10.1016/j.intimp.2005.02.009. Epub 2005 Mar 16.

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• Monserrat J, Asunsolo A, Gomez-Lahoz A, Ortega MA, Gasalla JM, Gasulla O, Fortuny-Profitos J, Mazaira-Font FA, Teixido Roman M, Arranz A, Sanz J, Munoz B, Arevalo-Serrano J, Rodriguez JM, Martinez-A C, Balomenos D, Alvarez-Mon M. Impact of the Innate Inflammatory Response on ICU Admission and Death in Hospitalized Patients with COVID-19. Biomedicines. 2021 Nov 12;9(11):1675. doi: 10.3390/biomedicines9111675.

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• Alvarez-Mon MA, Ortega MA, Garcia-Montero C, Fraile-Martinez O, Lahera G, Monserrat J, Gomez-Lahoz AM, Molero P, Gutierrez-Rojas L, Rodriguez-Jimenez R, Quintero J, Alvarez-Mon M. Differential malondialdehyde (MDA) detection in plasma samples of patients with major depressive disorder (MDD): A potential biomarker. J Int Med Res. 2022 May;50(5):3000605221094995. doi: 10.1177/03000605221094995.

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• Alvarez-Mon M, Ortega MA, Gasulla O, Fortuny-Profitos J, Mazaira-Font FA, Saurina P, Monserrat J, Plana MN, Troncoso D, Moreno JS, Munoz B, Arranz A, Varona JF, Lopez-Escobar A, Barco AA. A Predictive Model and Risk Factors for Case Fatality of COVID-19. J Pers Med. 2021 Jan 8;11(1):36. doi: 10.3390/jpm11010036.

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• Ortega MA, Fraile-Martinez O, Garcia-Montero C, Alvarez-Mon MA, Gomez-Lahoz AM, Albillos A, Lahera G, Quintero J, Monserrat J, Guijarro LG, Alvarez-Mon M. An Updated View of the Importance of Vesicular Trafficking and Transport and Their Role in Immune-Mediated Diseases: Potential Therapeutic Interventions. Membranes (Basel). 2022 May 25;12(6):552. doi: 10.3390/membranes12060552.

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• Lario M, Munoz L, Ubeda M, Borrero MJ, Martinez J, Monserrat J, Diaz D, Alvarez-Mon M, Albillos A. Defective thymopoiesis and poor peripheral homeostatic replenishment of T-helper cells cause T-cell lymphopenia in cirrhosis. J Hepatol. 2013 Oct;59(4):723-30. doi: 10.1016/j.jhep.2013.05.042. Epub 2013 Jun 3.

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• Alvarez-Mon MA, Gomez-Lahoz AM, Orozco A, Lahera G, Diaz D, Ortega MA, Albillos A, Quintero J, Auba E, Monserrat J, Alvarez-Mon M. Expansion of CD4 T Lymphocytes Expressing Interleukin 17 and Tumor Necrosis Factor in Patients with Major Depressive Disorder. J Pers Med. 2021 Mar 19;11(3):220. doi: 10.3390/jpm11030220.

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Related Links

• Inflammation and insulin resistance: mechanisms for the endothelial dysfunction development and atherosclerosis.
• Immunopathogenesis of aging: the impairment of innate immunity and its impact on specific immunity. Restoration by AM3.

MeSH Terms

Conditions

Metabolic Syndrome

Interventions

Immunoferon; Probiotics

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Julia Álvarez

  Servicio de Endocrinología y Nutrición del Hospital Universitario Príncipe de Asturias de Alcalá de Henares (Madrid)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ana López-Ballesteros

CONTACT

+34 671778847; ana.lopez@cantabrialabs.es

Mencía Hermosa-Vicente

CONTACT

+34 657850635; mencia.hermosa@cantabrialabs.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 26, 2023
• First Posted: December 6, 2023
• Study Start: May 20, 2024
• Primary Completion: November 1, 2025
• Study Completion: March 1, 2026
• Last Updated: June 26, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

ES (2)