Dyslipidemia
Conditions
Brief summary
Menopause is usually associated with an increase in body weight, a change in body composition and fat distribution and a large number of cardio-metabolic changes, such as hypertension, reduction of insulin-sensitivity and dyslipidaemia. The first-line strategy for these complications is the modification of dietary habits and lifestyle in terms of physical activity. Besides, there is also a growing interest in complementary therapies (i.e. nutraceuticals) that can be used alone or in combination to achieve more consistent results. In this context, preliminary evidence supports the potential role of some compounds of vegetal origin such as berberine, chlorogenic acid and tocotrienols. However, in support of their use, the evidence from good quality trials is limited.
Interventions
DIETARY_SUPPLEMENTNutraceutical
Nutritional counseling plus one pill of an active product (Trixy®) containing Berberine, Tocotrienols and Chlorogenic acid
OTHERControl
Nutritional counseling
Sponsors
University of Pavia
Fondazione IRCCS Policlinico San Matteo di Pavia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
Inclusion criteria
* LDL cholesterol \>100 mg/dL * Written informed consent available
Exclusion criteria
* Use of any drug affecting blood lipids * Hormone replacement therapy * Adherence to a weigh loss diet in the previous 6 months * Cancer diagnosis * Known thyroid, liver, renal or muscle diseases * Any medical or surgical condition which could lead to an inconstant adhesion to the protocol
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| LDL cholesterol | 3 months | LDL cholesterol |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total cholesterol | 3 months | Total cholesterol |
| HDL cholesterol | 3 months | HDL cholesterol |
| Blood glucose | 3 months | Blood glucose |
| Serum Insulin | 3 months | Serum Insulin |
| Insulin resistance | 3 months | Homeostatic model assessment (HOMA index) |
| Fat distribution | 3 months | Waist circumference |
| Fat Mass | 3 months | Fat Mass |
| Menopausal symptoms | 3 months | Greene Climacteric Scale |
| Quality of life | 3 months | 36-Item Short Form Health Survey (SF-36) |
| Body weight | 3 months | Body weight |
Countries
Italy
Outcome results
None listed