Cardiac Fibrosis, Metabolic Syndrome
Conditions
Brief summary
The study aims to evaluate the effects of an oral supplementation based on inositols and alpha-lactalbumin on principals metabolic parameters in patients with metabolic syndrome at risk of cardiac fibrosis
Interventions
DIETARY_SUPPLEMENTInositol and alpha-lactalbumin
The administration of an oral formulation based on inositol and alpha-lactalbumin (two sachets/day for 180 days)
Sponsors
Lo.Li.Pharma s.r.l
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
At least 3 of the following inclusion criteria: * triglycerides levels ≥ 150 mg/dL * HDL ≤ 40 mg/dL * Fasting glycemia \> 100 mg/dL \<126 mg/dl * Systolic Pressure ≥ 130 mmHg or Diastolic pressure ≥ 85 mmHg * Hip circumference \> 102 cm in men or 88 cm in women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Body weight | Four time points: changes in body weight (kg) from the baseline to 30, 90, 180 days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Tryglicerides | Four time points: changes in blood levels of tryglycerides from the baseline to 30, 90, 180 days | Plasmatic levels of tryglicerides |
| Hypertension | Four time points: changes in values of systolic and diastolic blood pressure from the baseline to 30, 90, 180 days | sphygmomanometer |
Countries
Italy
Outcome results
None listed