Clinical trial NCT06158152: A Pilot Study to Evaluate the Systemic Effect of Oral Supplementation With AM3 in Patients With Metabolic Syndrome.
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.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Metabolic Syndrome
Keywords: Metabolic Syndrome
AM3
Probiotics
Inmunoferon
Food suplement
Immune response
Lead sponsor: Industrial Farmacéutica Cantabria, S.A.
Sponsor class: INDUSTRY
First posted: 2023-12-06
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in serum cytokines.
timeFrame: Baseline and week 12
Secondary outcomes:
measure: Change in monocytes and natural killer cells levels.
timeFrame: Baseline and week 12
measure: Change in serum uric acid.
timeFrame: Baseline and week 12
measure: Change in serum sodium.
timeFrame: Baseline and week 12
measure: Change in serum potasium.
timeFrame: Baseline and week 12
measure: Change in serum bilirrubin.
timeFrame: Baseline and week 12
measure: Change in serum lipids
timeFrame: Baseline and week 12
measure: Change in serum glucose
timeFrame: Baseline and week 12
measure: Change in blood pressure
timeFrame: Baseline and week 12.
measure: Change in waist circumference
timeFrame: Baseline and week 12
measure: Change in hip circumference
timeFrame: Baseline and week 12
measure: Change in weight
timeFrame: Baseline and week 12
measure: Change in body mass index
timeFrame: Baseline and week 12
measure: Change in total body fat content
timeFrame: Baseline and week 12
measure: Change in patient's quality of life, assessed by the SF-12v2 score.
timeFrame: Baseline and week 12
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Hospital Universitario Infanta Leonor
city: Madrid
country: Spain
facility: Hospital Universitario Príncipe de Asturias
Study officials:
affiliation: Servicio de Endocrinología y Nutrición del Hospital Universitario Príncipe de Asturias de Alcalá de Henares (Madrid)
name: Julia Álvarez
role: PRINCIPAL_INVESTIGATOR
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