Metabolic SyndromeNCT06158152
A Pilot Study to Evaluate the Systemic Effect of Oral Supplementation With AM3 in Patients With Metabolic Syndrome.
A study testing AM3 + Probiotic and AM3 in people with Metabolic Syndrome, run by Industrial Farmacéutica Cantabria, S.A. at 2 sites in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Metabolic Syndrome
- What is being tested?
- AM3 + Probiotic and AM3
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 2 sitesSpain
- Study dates
- 20 May 2024to 1 Mar 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- 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.
Who cannot join
- 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).
Show all 15Show fewer
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Spain2 sites, 2 recruiting
- Recruiting
Hospital Universitario Infanta Leonor
Madrid
Cristina Sevillano
María Llavero
- Recruiting
Hospital Universitario Príncipe de Asturias
Madrid
Julia Álvarez
About this study
Official title: 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.
Read the 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:
- To determine the efficacy of the administration of a new food supplement for MS through the improvement of biochemical variables.
- To evaluate the efficacy of the administration of a new dietary supplement on the impact on body composition parameters.
- 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
- Being tested
- AM3 + Probiotic, Placebo, AM3
- Keywords
- Metabolic Syndrome, AM3, Probiotics, Inmunoferon, Food suplement, Immune response
- Medical subject headings
- Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AM3 + ProbioticDietary supplement
Two capsules daily in the morning during 12 weeks. The capsule contains the mixture of AM3 Technology and probiotic SynBalance Metsyn.
PlaceboDietary supplement
Two capsules daily in the morning during 12 weeks. The capsule contains starch.
AM3Dietary supplement
Two capsules daily in the morning during 12 weeks. The capsule contains AM3 Technology.
| Study group | Role | What they receive |
|---|---|---|
| Active arm | Active comparator | Patients who will receive the study treatment (AM3 Technology in combination with Probiotic SynBalance Metsyn) Receives: Dietary Supplement: AM3 + Probiotic |
| Placebo arm | Placebo comparator | Patients who will receive placebo treatment, consisting of starch capsules Receives: Dietary Supplement: Placebo |
| Control arm | Sham comparator | Patients to be treated with AM3 Technology capsules Receives: Dietary Supplement: AM3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in serum cytokines.
Circulating cytokine levels will be determined at baseline and at week 12 to assess the effect on inflammatory mediators.
Measured: Baseline and week 12
Secondary outcomes (14)
Change in monocytes and natural killer cells levels.
Serum monocytes and natural killers cells will be determined at baseline and week 12 to assess the effect on inflammatory status and oxidative stress.
Measured: Baseline and week 12
Change in serum uric acid.
Uric acid will be analized to assess the effect on inflammatory and metabolic mediators. These results will be displayed in the results data table.
Measured: Baseline and week 12
Change in serum sodium.
sodium will be analized to assess the effect on inflammatory and metabolic mediators. These results will be displayed in the results data table.
Measured: Baseline and week 12
Change in serum potasium.
potassium will be analized to assess the effect on inflammatory and metabolic mediators. These results will be displayed in the results data table.
Measured: Baseline and week 12
Change in serum bilirrubin.
Bilirrubin will be analized to assess the effect on inflammatory and metabolic mediators. These results will be displayed in the results data table.
Measured: Baseline and week 12
Change in serum lipids
Serum lipids will be determined at baseline and at week 12 to assess the effect on metabolic parameters.
Measured: Baseline and week 12
Change in serum glucose
Fasting blood glucose levels will be analized to assess the effect on inflammatory and metabolic mediators.
Measured: Baseline and week 12
Change in blood pressure
Blood pressure (Diastolic and systolic) [mmHg] will be determined at baseline and after 12 weeks of study treatment.
Measured: Baseline and week 12.
Change in waist circumference
Waist circumference [cm] will be obtained at baseline and at week 12 to assess the efficacy on body composition.
Measured: Baseline and week 12
Change in hip circumference
Hip circumference [cm] will be obtained at baseline and at week 12 to assess the efficacy on body composition.
Measured: Baseline and week 12
Change in weight
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.
Measured: Baseline and week 12
Change in body mass index
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.
Measured: Baseline and week 12
Change in total body fat content
Total body fat content will be measured at baseline and at week 12 using electrical bioimpedance.
Measured: Baseline and week 12
Change in patient's quality of life, assessed by the SF-12v2 score.
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.
Measured: Baseline and week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2023
- Study start20 May 2024
- Primary completion1 Nov 2025 (estimated)
- Study completion1 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (25)Papers the sponsor has linked to this study.
- Other trials for Metabolic SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Industrial Farmacéutica Cantabria, S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Julia Álvarez, Principal investigator, Servicio de Endocrinología y Nutrición del Hospital Universitario Príncipe de Asturias de Alcalá de Henares (Madrid)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06158152
- Sponsor's protocol ID
- P20110a
- Status last verified
- Jun 2025
- First submitted
- 26 Jul 2023
- Last updated
- 26 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Francisco V, Ruiz-Fernandez C, Pino J, Mera A, Gonzalez-Gay MA, Gomez R, Lago F, Mobasheri A, Gualillo O. Adipokines: Linking metabolic syndrome, the immune system, and arthritic diseases. Biochem Pharmacol. 2019 Jul;165:196-206. doi: 10.1016/j.bcp.2019.03.030. Epub 2019 Mar 22.
PubMed 30910694Mendrick DL, Diehl AM, Topor LS, Dietert RR, Will Y, La Merrill MA, Bouret S, Varma V, Hastings KL, Schug TT, Emeigh Hart SG, Burleson FG. Metabolic Syndrome and Associated Diseases: From the Bench to the Clinic. Toxicol Sci. 2018 Mar 1;162(1):36-42. doi: 10.1093/toxsci/kfx233.
PubMed 29106690Grandl G, Wolfrum C. Hemostasis, endothelial stress, inflammation, and the metabolic syndrome. Semin Immunopathol. 2018 Feb;40(2):215-224. doi: 10.1007/s00281-017-0666-5. Epub 2017 Dec 5.
PubMed 29209827Wang Q, Wu H. T Cells in Adipose Tissue: Critical Players in Immunometabolism. Front Immunol. 2018 Oct 30;9:2509. doi: 10.3389/fimmu.2018.02509. eCollection 2018.
PubMed 30459770Guerrero 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.
PubMed 11256233Vega-Robledo GB, Rico-Rosillo MG. [Adipose tissue: immune function and alterations caused by obesity]. Rev Alerg Mex. 2019 Jul-Sep;66(3):340-353. doi: 10.29262/ram.v66i3.589. Spanish.
PubMed 31606018Varela 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.
PubMed 12500425Ortega 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.
PubMed 15747716King 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.
PubMed 18673007Donath MY, Dinarello CA, Mandrup-Poulsen T. Targeting innate immune mediators in type 1 and type 2 diabetes. Nat Rev Immunol. 2019 Dec;19(12):734-746. doi: 10.1038/s41577-019-0213-9. Epub 2019 Sep 9.
PubMed 31501536Remely 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.
PubMed 27577947Serrano-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.
PubMed 17452477Prieto 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.
PubMed 11401877Brieva 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.
PubMed 11606029Majano 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.
PubMed 15914321
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT06158152
- Acronym / sponsor ID
- P20110a
- Conditions
- Metabolic Syndrome
- Keywords
- Metabolic Syndrome, AM3, Probiotics, Inmunoferon, Food suplement, Immune response
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Industrial Farmacéutica Cantabria, S.A.Industry (pharma, biotech, devices)
- Study start
- 20 May 2024 (actual)
- Primary completion
- 1 Nov 2025 (estimated)
- Study completion
- 1 Mar 2026 (estimated)
- First posted
- 6 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- To determine the efficacy of the administration of a new food supplement for MS through the improvement of biochemical variables.
- To evaluate the efficacy of the administration of a new dietary supplement on the impact on body composition parameters.
- 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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Active arm | Active comparator | Dietary Supplement: AM3 + ProbioticPatients who will receive the study treatment (AM3 Technology in combination with Probiotic SynBalance Metsyn) |
| Placebo arm | Placebo comparator | Dietary Supplement: PlaceboPatients who will receive placebo treatment, consisting of starch capsules |
| Control arm | Sham comparator | Dietary Supplement: AM3Patients to be treated with AM3 Technology capsules |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
- 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.
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AM3 + ProbioticTwo capsules daily in the morning during 12 weeks. The capsule contains the mixture of AM3 Technology and probiotic SynBalance Metsyn. | Dietary supplement | Active arm |
| PlaceboTwo capsules daily in the morning during 12 weeks. The capsule contains starch. | Dietary supplement | Placebo arm |
| AM3Two capsules daily in the morning during 12 weeks. The capsule contains AM3 Technology. | Dietary supplement | Control arm |
Primary outcome
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.
14 secondary outcomes
Change in monocytes and natural killer cells levels.
Time frame: Baseline and week 12
Change in serum uric acid.
Time frame: Baseline and week 12
Change in serum sodium.
Time frame: Baseline and week 12
Change in serum potasium.
Time frame: Baseline and week 12
Change in serum bilirrubin.
Time frame: Baseline and week 12
Change in serum lipids
Time frame: Baseline and week 12
Change in serum glucose
Time frame: Baseline and week 12
Change in blood pressure
Time frame: Baseline and week 12.
Change in waist circumference
Time frame: Baseline and week 12
Change in hip circumference
Time frame: Baseline and week 12
Change in weight
Time frame: Baseline and week 12
Change in body mass index
Time frame: Baseline and week 12
Change in total body fat content
Time frame: Baseline and week 12
Change in patient's quality of life, assessed by the SF-12v2 score.
Time frame: Baseline and week 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2025.
- Results publication: PubMed 30910694Francisco V, Ruiz-Fernandez C, Pino J, Mera A, Gonzalez-Gay MA, Gomez R, Lago F, Mobasheri A, Gualillo O. Adipokines: Linking metabolic syndrome, the immune system, and arthritic diseases. Biochem Pharmacol. 2019 Jul;165:196-206. doi: 10.1016/j.bcp.2019.03.030. Epub 2019 Mar 22.
- Results publication: PubMed 29106690Mendrick DL, Diehl AM, Topor LS, Dietert RR, Will Y, La Merrill MA, Bouret S, Varma V, Hastings KL, Schug TT, Emeigh Hart SG, Burleson FG. Metabolic Syndrome and Associated Diseases: From the Bench to the Clinic. Toxicol Sci. 2018 Mar 1;162(1):36-42. doi: 10.1093/toxsci/kfx233.
- Results publication: PubMed 29209827Grandl G, Wolfrum C. Hemostasis, endothelial stress, inflammation, and the metabolic syndrome. Semin Immunopathol. 2018 Feb;40(2):215-224. doi: 10.1007/s00281-017-0666-5. Epub 2017 Dec 5.
- Results publication: PubMed 30459770Wang Q, Wu H. T Cells in Adipose Tissue: Critical Players in Immunometabolism. Front Immunol. 2018 Oct 30;9:2509. doi: 10.3389/fimmu.2018.02509. eCollection 2018.
- Results publication: PubMed 11256233Guerrero 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.
- Results publication: PubMed 31606018Vega-Robledo GB, Rico-Rosillo MG. [Adipose tissue: immune function and alterations caused by obesity]. Rev Alerg Mex. 2019 Jul-Sep;66(3):340-353. doi: 10.29262/ram.v66i3.589. Spanish.
- Results publication: PubMed 12500425Varela 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.
- Results publication: PubMed 15747716Ortega 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.
- Results publication: PubMed 18673007King 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.
- Results publication: PubMed 31501536Donath MY, Dinarello CA, Mandrup-Poulsen T. Targeting innate immune mediators in type 1 and type 2 diabetes. Nat Rev Immunol. 2019 Dec;19(12):734-746. doi: 10.1038/s41577-019-0213-9. Epub 2019 Sep 9.
- Results publication: PubMed 27577947Remely 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.
- Results publication: PubMed 17452477Serrano-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.
- Inflammation and insulin resistance: mechanisms for the endothelial dysfunction development and atherosclerosis.Link provided by the sponsor.
- Immunopathogenesis of aging: the impairment of innate immunity and its impact on specific immunity. Restoration by AM3.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Julia Álvarez principal investigator
Servicio de Endocrinología y Nutrición del Hospital Universitario Príncipe de Asturias de Alcalá de Henares (Madrid)
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AM3 + Probiotic and AM3 in people with Metabolic Syndrome, run by Industrial Farmacéutica Cantabria, S.A. at 2 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ana López-Ballesteros (+34 671778847, ana.lopez@cantabrialabs.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in serum cytokines. (time frame: Baseline and week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06158152, which also lists 25 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2025.