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Completed

NCT Number: NCT04697121

Artichoke and Bergamot Phytosome

According to WHO data, about 50% of deaths each year are caused by cardiovascular disease. One of the strategies for prevention of cardiovascular diseases, in addition to a correct lifestyle, is to implement therapies that reduce the level of cholesterol in the blood and at the same time control the glycemic levels, which are closely related in the maintenance of metabolic homeostasis. The aim of this clinical study is to confirm the potential broader activity as hypocholesterolemic agent in bergamot poor-responders subjects with mild hypercholesterolemia. The study was a 8-week randomized double-blind placebo-controlled trial. Participants were randomized to either the supplement based on dry extract from artichoke leaf and bergamot phospholipid (31) or placebo arm (29).

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Key information

Conditions

Hypercholesterolemia Dyslipidemias Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Azienda di Servizi alla Persona

Pavia, 27100, Italy

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • mild hypercholesterolemia (220 - 280 mg/dl)
  • subjects were not taking any medication likely to affect lipid metabolism (such as statins)
  • subjects were bergamot poor-responders

Exclusion criteria

  • liver, renal and thyroid diseases
  • history of cardiovascular disease (CVD)

Treatment and study plan

Combined Bergamot phytosome and Artichoke leaf dry extract

Dietary Supplement

600 mg of Bergamot Phytosome and 100 mg of Artichoke leaf standardized dry extract. Supplementation regimen was 2 daily tablets, one before lunch and one before dinner, for 8 continuous weeks.

Placebo

Combination Product

Supplementation regimen was 2 daily tablets, one before lunch and one before dinner, for 8 continuous weeks.

Primary outcomes

  1. Changes of lipid parameters

    Time frame: Baseline / 30 days / 60 days

    Total cholesterol, LDL cholesterol, HDL cholesterol (mg/dl)

Secondary outcomes

  1. Changes of lipid parameters

    Time frame: Baseline / 30 days / 60 days

    apolipoprotein A, apolipoprotein B, triglycerides (mg/dl)

  2. Changes of metabolic parameters

    Time frame: Baseline / 30 days / 60 days

    Fasting blood glucose (mg/dl)

  3. Changes of metabolic parameters

    Time frame: Baseline / 30 days / 60 days

    Glycated Hemoglobin (percent)

  4. Changes of anthropometric measurements

    Time frame: Baseline / 30 days / 60 days

    Weight (kg) and height (m) were combined to report BMI in kg/m^2

  5. Changes of anthropometric measurements

    Time frame: Baseline / 30 days / 60 days

    waist circumference (cm)

  6. Changes of body composition

    Time frame: Baseline / 30 days / 60 days

    Fat mass (g), Fat Free Mass (g), Visceral Adipose Tissue (g)

  7. Changes of safety parameters

    Time frame: Baseline / 30 days / 60 days

    Aspartate Aminotransferase (UI/l), Alanine Aminotransferase (UI/l)

  8. Changes of safety parameters

    Time frame: Baseline / 30 days / 60 days

    Gamma Glutamyl Transferase (U/l)

  9. Changes of safety parameters

    Time frame: Baseline / 30 days / 60 days

    Creatinine (mg/dl)

Sponsors and collaborators

Lead sponsor

Azienda di Servizi alla Persona di Pavia

Other

Registry information

Official study title

Artichoke and Bergamot Phytosome: a Randomized Double Blind Clinical Trial in Bergamot Poor-responders

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jan 6, 2021
Registry last updated
Jan 6, 2021

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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