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OpenTrials
Completed

NCT Number: NCT03019263

Berberine, Chlorogenic Acid and Tocotrienols in Menopause-associated Dyslipidemia

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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Key information

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Fondazione IRCCS Policlinico San Matteo

Pavia, 27100, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nutraceutical

Dietary Supplement

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

Control

Other

Nutritional counseling

Primary outcomes

  1. LDL cholesterol

    Time frame: 3 months

    LDL cholesterol

Secondary outcomes

  1. Insulin resistance

    Time frame: 3 months

    Homeostatic model assessment (HOMA index)

  2. Total cholesterol

    Time frame: 3 months

    Total cholesterol

  3. HDL cholesterol

    Time frame: 3 months

    HDL cholesterol

  4. Blood glucose

    Time frame: 3 months

    Blood glucose

  5. Serum Insulin

    Time frame: 3 months

    Serum Insulin

  6. Body weight

    Time frame: 3 months

    Body weight

  7. Fat distribution

    Time frame: 3 months

    Waist circumference

  8. Fat Mass

    Time frame: 3 months

    Fat Mass

  9. Menopausal symptoms

    Time frame: 3 months

    Greene Climacteric Scale

  10. Quality of life

    Time frame: 3 months

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

Sponsors and collaborators

Lead sponsor

Fondazione IRCCS Policlinico San Matteo di Pavia

Other

Collaborators

  • University of Pavia

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jan 12, 2017
Registry last updated
May 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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