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New treatment option for Metabolic Syndrome
Official title A Pilot Study to Evaluate the Systemic Effect of Oral Supplementation With AM3 in Patients With Metabolic Syndrome.
ClinicalTrials.gov ID: NCT06158152
What this study is testing
- What it's testing
- 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.
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Men or women aged 18-75 years at the time of signing the informed consent form.
- Diagnosis of metabolic syndrome, defined as: central obesity, elevation of blood glucose by ≥100 mg/dl, glycosylated hemoglobin between 5.7 and 6.4%...
- If the patient is being treated with metformin, lipid-lowering treatment with statins or treatment with antihypertensives, he/she must have a stable...
You likely can't join if
- Smokers or with history of alcoholism or drug abuse .
- To have hypertriglyceridemia (\> 500 mg/dL).
- Uncontrolled arterial hypertension, as per investigator's criteria.
- To have undergone bariatric surgery over the last 24 months that according to investigator's criteria, this might interfere with his/her...
- Diagnosis of chronic diseases that according to investigator's criteria, this might interfere with his/her participation in the study.
- Presence of renal insufficiency (glomerular filtration rate below 30 ml/minute).
See the full eligibility criteria
- Men or women aged 18-75 years at the time of signing the informed consent form.
- Diagnosis of metabolic syndrome, defined as: 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...
- If the patient is being treated with metformin, lipid-lowering treatment with statins or treatment with antihypertensives, he/she must have a stable dose at the time of inclusion.
- Smokers or with history of alcoholism or drug abuse .
- To have hypertriglyceridemia (\> 500 mg/dL).
- Uncontrolled arterial hypertension, as per investigator's criteria.
- To have undergone bariatric surgery over the last 24 months that according to investigator's criteria, this might interfere with his/her participation in the study.
- Diagnosis of chronic diseases that according to investigator's criteria, this might interfere with his/her participation in the study.
- Presence of renal insufficiency (glomerular filtration rate below 30 ml/minute).
- Presence of severe respiratory insufficiency (PaO2 less than 60 mmHg or PaCO2 greater than 50 mmHg).
- Presence of heart failure (LVEF \<30% and RVEF \<35%).
- Presence of the following diseases in an unstable manner, according to the investigator's criteria: chronic obstructive disease, inflammatory bowel disease, intestinal malabsorption syndrome, systemic autoimmune...
- Active or chronic severe unstable infections that, in medical criteria, may interfere with patients' safety.
- Disease-related malnutrition.
- Endocrinologic unestable or uncontrolled diseases that in medical criteria, present with manifestations in pituitary, adrenal or thyroid function.
- Immunosuppressive or corticosteroid treatment in the last 3 months.
- Treatment with semaglutide and tirzepatide.
- Pregnant women (or intending to become pregnant) or breast-feeding women.
The study team makes the final eligibility decision.
Where it's taking place
- Madrid, Spain
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Madrid, Spain. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.