Back to resultsBerberine, Chlorogenic Acid and Tocotrienols in Menopause-associated Dyslipidemia
Primary Purpose
Dyslipidemia
Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Nutraceutical
Control
Sponsored by
About this trial
This is an interventional treatment trial for Dyslipidemia
Eligibility Criteria
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
Sites / Locations
- Fondazione IRCCS Policlinico San Matteo
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Nutraceutical
Control
Arm Description
Nutritional counseling plus one pill of an active product (Trixy®) containing Berberine, Tocotrienols and Chlorogenic acid
Nutritional counseling
Outcomes
Primary Outcome Measures
LDL cholesterol
LDL cholesterol
Secondary Outcome Measures
Insulin resistance
Homeostatic model assessment (HOMA index)
Total cholesterol
Total cholesterol
HDL cholesterol
HDL cholesterol
Blood glucose
Blood glucose
Serum Insulin
Serum Insulin
Body weight
Body weight
Fat distribution
Waist circumference
Fat Mass
Fat Mass
Menopausal symptoms
Greene Climacteric Scale
Quality of life
36-Item Short Form Health Survey (SF-36)
Full Information
NCT ID
NCT03019263
First Posted
January 10, 2017
Last Updated
January 12, 2018
Sponsor
IRCCS Policlinico S. Matteo
Collaborators
University of Pavia
1. Study Identification
Unique Protocol Identification Number
NCT03019263
Brief Title
Berberine, Chlorogenic Acid and Tocotrienols in Menopause-associated Dyslipidemia
Official Title
Nutraceutical Intervention With Berberine, Chlorogenic Acid and Tocotrienols for Menopause-associated Dyslipidemia: a Randomized, Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
March 31, 2017 (Actual)
Primary Completion Date
January 12, 2018 (Actual)
Study Completion Date
January 12, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
IRCCS Policlinico S. Matteo
Collaborators
University of Pavia
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dyslipidemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
63 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Nutraceutical
Arm Type
Experimental
Arm Description
Nutritional counseling plus one pill of an active product (Trixy®) containing Berberine, Tocotrienols and Chlorogenic acid
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Nutritional counseling
Intervention Type
Dietary Supplement
Intervention Name(s)
Nutraceutical
Intervention Description
Nutritional counseling plus one pill of an active product (Trixy®) containing Berberine, Tocotrienols and Chlorogenic acid
Intervention Type
Other
Intervention Name(s)
Control
Intervention Description
Nutritional counseling
Primary Outcome Measure Information:
Title
LDL cholesterol
Description
LDL cholesterol
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Insulin resistance
Description
Homeostatic model assessment (HOMA index)
Time Frame
3 months
Title
Total cholesterol
Description
Total cholesterol
Time Frame
3 months
Title
HDL cholesterol
Description
HDL cholesterol
Time Frame
3 months
Title
Blood glucose
Description
Blood glucose
Time Frame
3 months
Title
Serum Insulin
Description
Serum Insulin
Time Frame
3 months
Title
Body weight
Description
Body weight
Time Frame
3 months
Title
Fat distribution
Description
Waist circumference
Time Frame
3 months
Title
Fat Mass
Description
Fat Mass
Time Frame
3 months
Title
Menopausal symptoms
Description
Greene Climacteric Scale
Time Frame
3 months
Title
Quality of life
Description
36-Item Short Form Health Survey (SF-36)
Time Frame
3 months
10. Eligibility
Sex
Female
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Fondazione IRCCS Policlinico San Matteo
City
Pavia
ZIP/Postal Code
27100
Country
Italy
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Berberine, Chlorogenic Acid and Tocotrienols in Menopause-associated Dyslipidemia
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