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NCT06158152 | RECRUITING | Metabolic Syndrome

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

INDUSTRIAL PHARMACEUTICA 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.

Condition or disease

Metabolic Syndrome

Intervention/treatment

AM3 + Probiotic

Placebo

AM3

Phase

NA

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 Type : INTERVENTIONAL
Estimated Enrollment : 48 participants
Masking : DOUBLE
Primary Purpose : SUPPORTIVE_CARE
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.
Actual Study Start Date : 2024-05-20
Estimated Primary Completion Date : 2024-12-01
Estimated Study Completion Date : 2025-03-01

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 65 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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
A Pilot Study to Evaluate the Systemic Effect of Oral Supplementation With AM3 in Patients With Metabolic Syndrome.

Location Details

NCT06158152

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

Spain,

Infanta Leonor University Hospital

Madrid, Spain,

RECRUITING

Spain,

Prince of Asturias University Hospital

Madrid, Spain,