Nutraceutical Intervention With Berberine, Chlorogenic Acid and Tocotrienols for Menopause-associated Dyslipidemia: a Randomized, Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 63
- Locations
- 2
- Primary Endpoint
- LDL cholesterol
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Sex
- Female
- Accepts 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
Arms & Interventions
Nutraceutical
Nutritional counseling plus one pill of an active product (Trixy®) containing Berberine, Tocotrienols and Chlorogenic acid
Intervention: Nutraceutical (Dietary Supplement)
Control
Nutritional counseling
Intervention: Control (Other)
Outcomes
Primary Outcomes
LDL cholesterol
Time Frame: 3 months
LDL cholesterol
Secondary Outcomes
- Total cholesterol(3 months)
- HDL cholesterol(3 months)
- Blood glucose(3 months)
- Serum Insulin(3 months)
- Body weight(3 months)
- Insulin resistance(3 months)
- Fat distribution(3 months)
- Fat Mass(3 months)
- Quality of life(3 months)
- Menopausal symptoms(3 months)
Investigators
Riccardo Caccialanza
Principal Investigator
Fondazione IRCCS Policlinico San Matteo di Pavia