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CompletedNCT03019263Updated May 1, 2025

Berberine, Chlorogenic Acid and Tocotrienols in Menopause-associated Dyslipidemia

An interventional study of Nutraceutical and Control in Dyslipidemia, sponsored by Fondazione IRCCS Policlinico San Matteo di Pavia. Completed at 1 site in Italy. Open to female participants. Per ClinicalTrials.gov, last updated 2025-05-01.

Sponsored by Fondazione IRCCS Policlinico San Matteo di Pavia · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
63
Allocation
Randomized
Sex
Female
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Study 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.

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Conditions studied

  • Dyslipidemia

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03

In context

Dyslipidemias

1,073 studies on the registry are indexed under Dyslipidemias; 158 are open to participants now.

This study's enrollment of 63 is below the median of 99 across 842 interventional studies indexed under Dyslipidemias.

Browse Dyslipidemias studies →

Lead sponsor

Fondazione IRCCS Policlinico San Matteo di Pavia is the lead sponsor of 255 studies on the registry; 113 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  • LDL cholesterol >100 mg/dL
  • Written informed consent available

Exclusion criteria

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
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
63 participants (actual)

Study arms

  • Experimental
    Nutraceutical

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

    Dietary Supplement: Nutraceutical

  • Active comparator
    Control

    Nutritional counseling

    Other: Control

Interventions

  • Dietary supplementNutraceutical

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

  • OtherControl

    Nutritional counseling

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What researchers measure

Primary outcomes

  1. LDL cholesterol

    LDL cholesterol

    Time frame: 3 months

Secondary outcomes

  1. Insulin resistance

    Homeostatic model assessment (HOMA index)

    Time frame: 3 months

  2. Total cholesterol

    Total cholesterol

    Time frame: 3 months

  3. HDL cholesterol

    HDL cholesterol

    Time frame: 3 months

  4. Blood glucose

    Blood glucose

    Time frame: 3 months

  5. Serum Insulin

    Serum Insulin

    Time frame: 3 months

  6. Body weight

    Body weight

    Time frame: 3 months

  7. Fat distribution

    Waist circumference

    Time frame: 3 months

  8. Fat Mass

    Fat Mass

    Time frame: 3 months

  9. Menopausal symptoms

    Greene Climacteric Scale

    Time frame: 3 months

  10. Quality of life

    36-Item Short Form Health Survey (SF-36)

    Time frame: 3 months

07

Study locations

1 site
  • Fondazione IRCCS Policlinico San Matteo
    Pavia, 27100, Italy
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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 1, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03019263
Lead sponsor
Fondazione IRCCS Policlinico San Matteo di Pavia
Collaborators
University of Pavia
Responsible party
Riccardo Caccialanza (Principal Investigator, Fondazione IRCCS Policlinico San Matteo di Pavia) — Principal investigator
First posted
Jan 12, 2017
Start date
Mar 31, 2017
Primary completion
Jan 12, 2018
Completion
Jan 12, 2018
Last update
May 1, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.

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