Berberine, Chlorogenic Acid and Tocotrienols in Menopause-associated Dyslipidemia

January 12, 2018 updated by: Riccardo Caccialanza, IRCCS Policlinico S. Matteo

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

63

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Pavia, Italy, 27100
        • Fondazione IRCCS Policlinico San Matteo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
LDL cholesterol
Time Frame: 3 months
LDL cholesterol
3 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IRCCS Policlinico S. Matteo

Collaborators

University of Pavia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 31, 2017

Primary Completion (Actual)

January 12, 2018

Study Completion (Actual)

January 12, 2018

Study Registration Dates

First Submitted

January 10, 2017

First Submitted That Met QC Criteria

January 10, 2017

First Posted (Estimate)

January 12, 2017

Study Record Updates

Last Update Posted (Actual)

January 16, 2018

Last Update Submitted That Met QC Criteria

January 12, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20140012470

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Dyslipidemia

Clinical Trials on Nutraceutical

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in United States

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe