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

Study Overview
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Brief Summary
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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
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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 65 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.

Official Title
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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.

Conditions
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Metabolic Syndrome

Intervention / Treatment
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* Dietary Supplement: AM3 + Probiotic
* Dietary Supplement: Placebo
* Dietary Supplement: AM3


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men or women aged 18-65 years at the time of signing the informed consent form Metabolic syndrome diagnosis: 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 Patient without treatment with metformin or if on stable treatment, with no changes in the dosage, for at least 3 months Hypolipidemic treatment with statins unchanged for the last 6 months Treatment with antihypertensives (other than beta-blockers) unchanged for the last 6 months Follow the lifestyle recommendations: nutritional, physical exercise, as recommended by your specialist Exclusion Criteria: Smokers or with history of alcoholism or drug abuse Have started treatment with metformin or have modified its dosage in the last 3 months To have hypertriglyceridemia Uncontrolled arterial hypertension To have undergone bariatric surgery within the last two years Diagnosis of chronic diseases and metabolic complications (diabetes, myocardial infarction, renal disease, COPD, cardiovascular disease or thyroid disease) Presence of renal, respiratory or cardiac insufficiency Presence of chronic obstructive disease, inflammatory bowel disease, intestinal malabsorption syndrome, systemic autoimmune diseases, rheumatoid arthritis, spondyloarthritis, psoriasis and chronic inflammatory skin diseases Active or chronic infections Psychosis Disease-related malnutrition Endocrinologic diseases with manifestations in pituitary, adrenal or thyroid function Immunosuppressive treatment in the last 3 months Being breast-feeding, pregnant or intending to become pregnant

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Active arm<br>Patients who will receive the study treatment (AM3 Technology in combination with Probiotic SynBalance Metsyn) | Dietary Supplement: AM3 + Probiotic<br>* Two capsules daily in the morning during 12 weeks. The capsule contains the mixture of AM3 Technology and probiotic SynBalance Metsyn.<br>|
| Placebo Comparator: Placebo arm<br>Patients who will receive placebo treatment, consisting of starch capsules | Dietary Supplement: Placebo<br>* Two capsules daily in the morning during 12 weeks. The capsule contains starch.<br>|
| Sham Comparator: Control arm<br>Patients to be treated with AM3 Technology capsules | Dietary Supplement: AM3<br>* Two capsules daily in the morning during 12 weeks. The capsule contains AM3 Technology.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | 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. | 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. | Baseline and week 12 | 
| Change in serum glucose | Fasting blood glucose levels will be analized to assess the effect on inflammatory and metabolic mediators. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | Baseline and week 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Metabolic Syndrome, AM3, Probiotics, Inmunoferon, Food suplement, Immune response