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

Not Applicable

Recruiting

• Conditions: Metabolic Syndrome
• Interventions: Dietary Supplement: AM3 + Probiotic; Dietary Supplement: Placebo; Dietary Supplement: AM3

• Registration Number: NCT06158152
• Lead Sponsor: Industrial Farmacéutica Cantabria, S.A.

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.

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 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.

Study Timeline

• Study First Submitted: 2023-07-26
• Study First Submitted QC: 2023-11-27
• Study First Posted: 2023-12-06
• Study Start: 2024-05-20
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-20
• Last Update Posted: 2024-08-21
• Primary Completion: 2024-12-01
• Study Completion: 2025-03-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

1. Men or women aged 18-65 years at the time of signing the informed consent form
2. 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
3. Patient without treatment with metformin or if on stable treatment, with no changes in the dosage, for at least 3 months
4. Hypolipidemic treatment with statins unchanged for the last 6 months
5. Treatment with antihypertensives (other than beta-blockers) unchanged for the last 6 months
6. Follow the lifestyle recommendations: nutritional, physical exercise, as recommended by your specialist

Exclusion Criteria

1. Smokers or with history of alcoholism or drug abuse
2. Have started treatment with metformin or have modified its dosage in the last 3 months
3. To have hypertriglyceridemia
4. Uncontrolled arterial hypertension
5. To have undergone bariatric surgery within the last two years
6. Diagnosis of chronic diseases and metabolic complications (diabetes, myocardial infarction, renal disease, COPD, cardiovascular disease or thyroid disease)
7. Presence of renal, respiratory or cardiac insufficiency
8. Presence of chronic obstructive disease, inflammatory bowel disease, intestinal malabsorption syndrome, systemic autoimmune diseases, rheumatoid arthritis, spondyloarthritis, psoriasis and chronic inflammatory skin diseases
9. Active or chronic infections
10. Psychosis
11. Disease-related malnutrition
12. Endocrinologic diseases with manifestations in pituitary, adrenal or thyroid function
13. Immunosuppressive treatment in the last 3 months
14. Being breast-feeding, pregnant or intending to become pregnant

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active arm	AM3 + Probiotic	Patients who will receive the study treatment (AM3 Technology in combination with Probiotic SynBalance Metsyn)
Placebo arm	Placebo	Patients who will receive placebo treatment, consisting of starch capsules
Control arm	AM3	Patients to be treated with AM3 Technology capsules

Primary Outcome Measures

Name	Time	Method
Change in serum cytokines.	Baseline and week 12	Circulating cytokine levels will be determined at baseline and at week 12 to assess the effect on inflammatory mediators.

Secondary Outcome Measures

Name	Time	Method
Change in monocytes and natural killer cells levels.	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.
Change in hip circumference	Baseline and week 12	Hip circumference \[cm\] will be obtained at baseline and at week 12 to assess the efficacy on body composition.
Change in serum glucose	Baseline and week 12	Fasting blood glucose levels will be analized to assess the effect on inflammatory and metabolic mediators.
Change in serum lipids	Baseline and week 12	Serum lipids will be determined at baseline and at week 12 to assess the effect on metabolic parameters.
Change in serum bilirrubin.	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.
Change in weight	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.
Change in body mass index	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.
Change in serum uric acid.	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.
Change in serum potasium.	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.
Change in waist circumference	Baseline and week 12	Waist circumference \[cm\] will be obtained at baseline and at week 12 to assess the efficacy on body composition.
Change in total body fat content	Baseline and week 12	Total body fat content will be measured at baseline and at week 12 using electrical bioimpedance.
Change in serum sodium.	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.
Change in blood pressure	Baseline and week 12.	Blood pressure (Diastolic and systolic) \[mmHg\] will be determined at baseline and after 12 weeks of study treatment.
Change in patient's quality of life, assessed by the SF-12v2 score.	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.

Trial Locations

Locations (2)

Hospital Universitario Príncipe de Asturias; 🇪🇸 Madrid, Spain

Hospital Universitario Infanta Leonor; 🇪🇸 Madrid, Spain