Berberine, Chlorogenic Acid and Tocotrienols in Menopause-associated Dyslipidemia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

63 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-31

Study Completion Date

2018-01-12

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.

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Detailed Description

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Conditions

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Dyslipidemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Nutraceutical

Nutritional counseling plus one pill of an active product (Trixy®) containing Berberine, Tocotrienols and Chlorogenic acid

Group Type EXPERIMENTAL

Nutraceutical

Intervention Type DIETARY_SUPPLEMENT

Nutritional counseling plus one pill of an active product (Trixy®) containing Berberine, Tocotrienols and Chlorogenic acid

Control

Nutritional counseling

Group Type ACTIVE_COMPARATOR

Control

Intervention Type OTHER

Nutritional counseling

Interventions

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Nutraceutical

Nutritional counseling plus one pill of an active product (Trixy®) containing Berberine, Tocotrienols and Chlorogenic acid

Intervention Type DIETARY_SUPPLEMENT

Control

Nutritional counseling

Intervention Type OTHER

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

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No