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

Cantabria Labs

Status: Not yet enrolling

Conditions: Metabolic Syndrome

Treatments: Dietary Supplement: Placebo; Dietary Supplement: AM3 + Probiotic; Dietary Supplement: AM3

Study type: Interventional

Funder types: Industry

Identifiers

NCT06158152

P20110a

Details and patient eligibility

About

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.

Full 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 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.

Enrollment: 48 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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48 participants in 3 patient groups, including a placebo group

Active arm

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: AM3 + Probiotic

Placebo arm

Placebo Comparator group

Description:

Patients who will receive placebo treatment, consisting of starch capsules

Treatment:

Dietary Supplement: Placebo

Control arm

Sham Comparator group

Description:

Patients to be treated with AM3 Technology capsules

Treatment:

Dietary Supplement: AM3