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Berberine, Chlorogenic Acid and Tocotrienols in Menopause-associated Dyslipidemia

I

IRCCS Policlinico S. Matteo

Status

Completed

Conditions

Dyslipidemia

Treatments

Other: Control
Dietary Supplement: Nutraceutical

Study type

Interventional

Funder types

Other

Identifiers

NCT03019263
20140012470

Details and patient eligibility

About

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.

Enrollment

63 patients

Sex

Female

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

63 participants in 2 patient groups

Nutraceutical
Experimental group
Description:
Nutritional counseling plus one pill of an active product (Trixy®) containing Berberine, Tocotrienols and Chlorogenic acid
Treatment:
Dietary Supplement: Nutraceutical
Control
Active Comparator group
Description:
Nutritional counseling
Treatment:
Other: Control

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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