Fondazione IRCCS Policlinico San Matteo
Pavia, 27100, Italy
NCT Number: NCT03019263
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.
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Interventional
Not applicable
Pavia, 27100, Italy
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Nutritional counseling plus one pill of an active product (Trixy®) containing Berberine, Tocotrienols and Chlorogenic acid
Nutritional counseling
Time frame: 3 months
LDL cholesterol
Time frame: 3 months
Homeostatic model assessment (HOMA index)
Time frame: 3 months
Total cholesterol
Time frame: 3 months
HDL cholesterol
Time frame: 3 months
Blood glucose
Time frame: 3 months
Serum Insulin
Time frame: 3 months
Body weight
Time frame: 3 months
Waist circumference
Time frame: 3 months
Fat Mass
Time frame: 3 months
Greene Climacteric Scale
Time frame: 3 months
36-Item Short Form Health Survey (SF-36)
Fondazione IRCCS Policlinico San Matteo di Pavia
Other
Nutraceutical Intervention With Berberine, Chlorogenic Acid and Tocotrienols for Menopause-associated Dyslipidemia: a Randomized, Controlled Trial
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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