Effect of a Dietary Supplement on Lipid Pattern and Liver Parameters in Hypercholesterolemia

NCT04485793 | Completed

• 1 other identifier: NUT1-BO-2019
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The joint ESC/EAS guidelines for the management of dyslipidaemias recommend, for patients at low/moderate CV risk with raised LDL-C, a set of measures collectively defined as "lifestyle interventions", with use of drugs only if the LDL-C levels cannot be controlled with such lifestyle interventions. "Lifestyle interventions" also includes food supplements. The reason is the following: a simple "dietary advice" has been shown (Cochrane review and meta-analysis, Rees et al, 2013) to achieve a modest reduction of total-C and LDL-C. The review reports: Dietary advice reduced total serum cholesterol by 0.15 mmol/L (95% CI 0.06 to 0.23) and LDL cholesterol by 0.16 mmol/L (95% CI 0.08 to 0.24) after 3 to 24 months." An average reduction of LDL-C by 0.16 mmol/L (6.2 mg/dL) is definitely insufficient to control the level of LDL-C in those subjects. Therefore, those subjects would lose motivation to keep dieting. In this context, use of supplements would significantly amplify the result of diet. A significant proportion of ischemic cardiovascular events are believed to be supported by the coexistence of traditional cardiovascular risk factors such as diabetes, hypertension, dyslipidemia, smoking, and others. The aggregation of these factors is accompanied by a significant increase in the risk of cardiovascular events. Observational studies shown the existence of a relationship between cholesterolemia and coronary heart disease, clearly showing that subjects with even modestly increased total cholesterol values over time develop both fatal and non-fatal vascular events with a higher frequency compared to subjects with similar characteristics, but with lower basal values of cholesterol. Numerous controlled intervention studies, on the other hand, have shown that there is a close correlation between cholesterol reduction and cardiovascular risk; in fact, reductions in the plasma concentration of total and LDL-C, obtained through lifestyle modification or specific drugs, result in reductions in the incidence of major coronary events. The effectiveness of these interventions has been demonstrated both in subjects in primary prevention and in patients in secondary prevention.

Conditions

Hypercholesterolemia

Outcome Measures

Primary Outcomes (2)

• LDL-cholesterolemia absolute reduction from baseline and between groups

  Absolute reduction of LDL-cholesterolemia after 12 weeks of treatment

  12 weeks

• LDL-cholesterolemia % reduction from baseline and between groups

  % reduction of LDL-cholesterolemia after 12 weeks of treatment

  12 weeks

Secondary Outcomes (10)

• Absolute reduction from baseline and between groups in other lipid fractions, apolipoproteins and their ratios

  12 weeks

• % reduction from baseline and between groups in other lipid fractions, apolipoproteins and their ratios

  12 weeks

• % reduction from baseline and between groups in anthropometric parameters

  12 weeks

• % reduction from baseline and between groups in blood pressure levels

  12 weeks

• Absolute reduction from baseline and between groups in blood pressure levels

  12 weeks

Study Arms (2)

Active Comparator

ACTIVE COMPARATOR

Dietary supplement

Dietary Supplement: Dietary supplement

Placebo comparator

PLACEBO COMPARATOR

Placebo

Other: Placebo

Interventions

Dietary supplement DIETARY_SUPPLEMENT

Dietary supplement formulated with 400 mg Bergamot d.e. obtained from different parts of the Citrus Bergamot whole fruit (Citrus bergamia Risso et Poiteau, fructus), specifically from fresh fruits collected from November to February (Brumex TM). Oral administration: 1 tablet/day at evening meal

Active Comparator

Placebo OTHER

Oral administration: 1 tablet/day at evening meal

Placebo comparator

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects agree to participate in the study and having dated and signed the informed consent form.
• Subjects who have the capability to communicate, to make themselves understood, and to comply with the study's requirements.
• Male or female aged ≥ 18 years and ≤ 70 years old.
• LDL-Cholesterol plasma levels \>115 mg/dL and \< 190 mg/dL.
• TG\<400 mg/dL.
• Subjects who, according to the SCORE charts, have a low or moderate cardiovascular risk (defined as a total cardiovascular risk \< 5%) and for whom, according to ESC/EAS guidelines 2012, the intervention strategy does not require a pharmacological lipid-lowering intervention.

You may not qualify if:

• Subjects already affected by cardiovascular diseases (secondary prevention) or with estimated 10 years cardiovascular disease risk\> 5%;
• Obesity (BMI\>30 kg/m2) or diabetes mellitus;
• Assumption of lipid lowering drugs or food supplements, or drugs potentially affecting the lipid metabolism;
• Antihypertensive treatment not stabilized since at least 3 months;
• Anticoagulants therapy
• Uncontrolled hypertension (systolic blood pressure\> 190 mmHg or diastolic arterial pressure\> 100 mmHg);
• Known current thyroid, gastrointestinal or hepatobiliary diseases;
• Any medical or surgical condition that would limit the patient adhesion to the study protocol;
• Abuse of alcohol or drugs (current or previous);
• History of malignant neoplasia in the 5 years prior to enrolment in the study;
• History or clinical evidence of inflammatory disease such as severe arthritis, systemic lupus erythematosus or chronic inflammatory diseases or current therapy with immunosuppressive agents or long-term glucocorticoids;
• History or clinical evidence of any significant concomitant disease that could compromise the safety of the subject or the possibility of completing the study;
• Known previous intolerance to the tested nutraceutical
• Women in fertile age not using consolidated contraceptive methods
• Pregnancy and Breastfeeding.

Sponsors & Collaborators

• University of Bologna: lead

Study Sites (1)

University of Bologna

Bologna, BO, 40138, Italy

Location

Related Publications (1)

• Pierdomenico M, Cicero AFG, Veronesi M, Fogacci F, Riccioni C, Benassi B. Effect of Citrus bergamia extract on lipid profile: A combined in vitro and human study. Phytother Res. 2023 Sep;37(9):4185-4195. doi: 10.1002/ptr.7897. Epub 2023 Jun 13.

  PMID: 37312672 RESULT

MeSH Terms

Conditions

Hypercholesterolemia

Interventions

Dietary Supplements

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Claudio Borghi, MD

  S. Orsola-Malpighi University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 21, 2020
• First Posted: July 24, 2020
• Study Start: September 21, 2020
• Primary Completion: October 4, 2021
• Study Completion: October 4, 2021
• Last Updated: January 31, 2024

Record last verified: 2024-01

Locations

IT (1)