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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
63
Nutritional counseling plus one pill of an active product (Trixy®) containing Berberine, Tocotrienols and Chlorogenic acid
Nutritional counseling
Fondazione IRCCS Policlinico San Matteo
Pavia, Italy
LDL cholesterol
LDL cholesterol
Time frame: 3 months
Insulin resistance
Homeostatic model assessment (HOMA index)
Time frame: 3 months
Total cholesterol
Total cholesterol
Time frame: 3 months
HDL cholesterol
HDL cholesterol
Time frame: 3 months
Blood glucose
Blood glucose
Time frame: 3 months
Serum Insulin
Serum Insulin
Time frame: 3 months
Body weight
Body weight
Time frame: 3 months
Fat distribution
Waist circumference
Time frame: 3 months
Fat Mass
Fat Mass
Time frame: 3 months
Menopausal symptoms
Greene Climacteric Scale
Time frame: 3 months
Quality of life
36-Item Short Form Health Survey (SF-36)
Time frame: 3 months
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