Berberine, Chlorogenic Acid and Tocotrienols in Menopause-associated Dyslipidemia

What this trial studies

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.

Conditions in scope

• Dyslipidemia

Interventions

• Nutraceutical (Dietary Supplement) — Nutritional counseling plus one pill of an active product (Trixy®) containing Berberine, Tocotrienols and Chlorogenic acid
• Control (Other) — Nutritional counseling

Who can join

Women only · Adults (Child, Adult, Older Adult)

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

Eligibility wording paraphrased from the public record. View the full criteria on ClinicalTrials.gov before contacting a site.

Where it’s happening

Status & timeline

• Overall status: Completed
• Study type: Interventional
• Phase: N/A
• Start date: 2017-03-31
• Primary completion: 2018-01-12
• Last update posted: 2025-05-01
• First posted: 2017-01-12

Sponsor & contact

Lead sponsor: Fondazione IRCCS Policlinico San Matteo di Pavia (Other)

Collaborators: University of Pavia

For trial site contact information, use the official record at ClinicalTrials.gov. Contact details change frequently and the public record is the source of truth.

Outcome measures

Primary outcomes

• LDL cholesterol (3 months)
  LDL cholesterol

Related ClearedRx care

If you’re reading this trial because you have menopause symptoms now, you don’t have to wait for a trial to access evidence-based care. ClearedRx prescribes the same FDA-approved and compounded HRT products that have been studied in trials like this one for decades.