Berberine, Chlorogenic Acid and Tocotrienols in Menopause-associated Dyslipidemia

Study Overview
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Brief Summary
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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.

Official Title
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Nutraceutical Intervention With Berberine, Chlorogenic Acid and Tocotrienols for Menopause-associated Dyslipidemia: a Randomized, Controlled Trial

Conditions
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Dyslipidemia

Intervention / Treatment
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* Dietary Supplement: Nutraceutical
* Other: Control


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nutraceutical<br>Nutritional counseling plus one pill of an active product (Trixy®) containing Berberine, Tocotrienols and Chlorogenic acid | Dietary Supplement: Nutraceutical<br>* Nutritional counseling plus one pill of an active product (Trixy®) containing Berberine, Tocotrienols and Chlorogenic acid<br>|
| Active Comparator: Control<br>Nutritional counseling | Other: Control<br>* Nutritional counseling<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| LDL cholesterol | LDL cholesterol | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insulin resistance | Homeostatic model assessment (HOMA index) | 3 months | 
| Total cholesterol | Total cholesterol | 3 months | 
| HDL cholesterol | HDL cholesterol | 3 months | 
| Blood glucose | Blood glucose | 3 months | 
| Serum Insulin | Serum Insulin | 3 months | 
| Body weight | Body weight | 3 months | 
| Fat distribution | Waist circumference | 3 months | 
| Fat Mass | Fat Mass | 3 months | 
| Menopausal symptoms | Greene Climacteric Scale | 3 months | 
| Quality of life | 36-Item Short Form Health Survey (SF-36) | 3 months |