A Pilot Study to Evaluate the Systemic Effect of Oral Supplementation With AM3 in Patients With Metabolic Syndrome.
- Conditions
- Metabolic Syndrome
- Registration Number
- NCT06158152
- Lead Sponsor
- Industrial Farmacéutica Cantabria, S.A.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 48
Inclusion Criteria:<br><br> 1. Men or women aged 18-65 years at the time of signing the informed consent form<br><br> 2. Metabolic syndrome diagnosis: central obesity, elevation of blood glucose by =100<br> mg/dl, glycosylated hemoglobin between 5.7 and 6.4%, low HDL cholesterol levels < 40<br> mg/dl in men and < 50 mg/dl in women, and high levels of triglycerides, being higher<br> than 150 mg/dl<br><br> 3. Patient without treatment with metformin or if on stable treatment, with no changes<br> in the dosage, for at least 3 months<br><br> 4. Hypolipidemic treatment with statins unchanged for the last 6 months<br><br> 5. Treatment with antihypertensives (other than beta-blockers) unchanged for the last 6<br> months<br><br> 6. Follow the lifestyle recommendations: nutritional, physical exercise, as recommended<br> by your specialist<br><br>Exclusion Criteria:<br><br> 1. Smokers or with history of alcoholism or drug abuse<br><br> 2. Have started treatment with metformin or have modified its dosage in the last 3<br> months<br><br> 3. To have hypertriglyceridemia<br><br> 4. Uncontrolled arterial hypertension<br><br> 5. To have undergone bariatric surgery within the last two years<br><br> 6. Diagnosis of chronic diseases and metabolic complications (diabetes, myocardial<br> infarction, renal disease, COPD, cardiovascular disease or thyroid disease)<br><br> 7. Presence of renal, respiratory or cardiac insufficiency<br><br> 8. Presence of chronic obstructive disease, inflammatory bowel disease, intestinal<br> malabsorption syndrome, systemic autoimmune diseases, rheumatoid arthritis,<br> spondyloarthritis, psoriasis and chronic inflammatory skin diseases<br><br> 9. Active or chronic infections<br><br> 10. Psychosis<br><br> 11. Disease-related malnutrition<br><br> 12. Endocrinologic diseases with manifestations in pituitary, adrenal or thyroid<br> function<br><br> 13. Immunosuppressive treatment in the last 3 months<br><br> 14. Being breast-feeding, pregnant or intending to become pregnant
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in serum cytokines.
- Secondary Outcome Measures
Name Time Method Change in monocytes and natural killer cells levels.;Change in serum uric acid.;Change in serum sodium.;Change in serum potasium.;Change in serum bilirrubin.;Change in serum lipids;Change in serum glucose;Change in blood pressure;Change in waist circumference;Change in hip circumference;Change in weight;Change in body mass index;Change in total body fat content;Change in patient's quality of life, assessed by the SF-12v2 score.