Berberine, Chlorogenic Acid and Tocotrienols in Menopause-associated Dyslipidemia

Not Applicable

Completed

• Conditions: Dyslipidemia
• Interventions: Other: Control; Dietary Supplement: Nutraceutical

• Registration Number: NCT03019263
• Lead Sponsor: Fondazione IRCCS Policlinico San Matteo di Pavia

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-01-10
• Study First Submitted QC: 2017-01-10
• Study First Posted: 2017-01-12
• Study Start: 2017-03-31
• Primary Completion: 2018-01-12
• Study Completion: 2018-01-12
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-29
• Last Update Posted: 2025-05-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 63

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
LDL cholesterol	3 months	LDL cholesterol

Secondary Outcome Measures

Name	Time	Method
Total cholesterol	3 months	Total cholesterol
HDL cholesterol	3 months	HDL cholesterol
Blood glucose	3 months	Blood glucose
Serum Insulin	3 months	Serum Insulin
Body weight	3 months	Body weight
Insulin resistance	3 months	Homeostatic model assessment (HOMA index)
Fat distribution	3 months	Waist circumference
Fat Mass	3 months	Fat Mass
Quality of life	3 months	36-Item Short Form Health Survey (SF-36)
Menopausal symptoms	3 months	Greene Climacteric Scale

Trial Locations

Locations (1)

Fondazione IRCCS Policlinico San Matteo; 🇮🇹 Pavia, Italy