Berberine, Chlorogenic Acid and Tocotrienols in Menopause-associated Dyslipidemia
Nutraceutical Intervention With Berberine, Chlorogenic Acid and Tocotrienols for Menopause-associated Dyslipidemia: a Randomized, Controlled Trial
1 other identifier
interventional
63
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2017
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 10, 2017
CompletedFirst Posted
Study publicly available on registry
January 12, 2017
CompletedStudy Start
First participant enrolled
March 31, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 12, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
January 12, 2018
CompletedMay 1, 2025
April 1, 2025
10 months
January 10, 2017
April 29, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
LDL cholesterol
LDL cholesterol
3 months
Secondary Outcomes (10)
Insulin resistance
3 months
Total cholesterol
3 months
HDL cholesterol
3 months
Blood glucose
3 months
Serum Insulin
3 months
- +5 more secondary outcomes
Study Arms (2)
Nutraceutical
EXPERIMENTALNutritional counseling plus one pill of an active product (Trixy®) containing Berberine, Tocotrienols and Chlorogenic acid
Control
ACTIVE COMPARATORNutritional counseling
Interventions
Nutritional counseling plus one pill of an active product (Trixy®) containing Berberine, Tocotrienols and Chlorogenic acid
Eligibility Criteria
You may qualify if:
- LDL cholesterol \>100 mg/dL
- Written informed consent available
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Fondazione IRCCS Policlinico San Matteo
Pavia, 27100, Italy
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
January 10, 2017
First Posted
January 12, 2017
Study Start
March 31, 2017
Primary Completion
January 12, 2018
Study Completion
January 12, 2018
Last Updated
May 1, 2025
Record last verified: 2025-04