Evaluation of Food Supplementation in Subjects With Suboptimal Levels of LDL Cholesterol

Evaluation of the Effect of a Food Supplementation With a Combined Food Supplement in Healthy Subjects With Suboptimal LDL-C Levels: a Two-arm Double-blind, Placebo- Controlled, Randomized, Clinical Trial.

This randomized, double-blind, placebo-controlled, parallel-group clinical study aims to evaluate the effect of a dietary supplement on LDL-cholesterol levels in healthy adults with suboptimal LDL-C values. Eligible participants will follow standard dietary recommendations based on the Mediterranean diet, according to the European Atherosclerosis Society guidelines. Subjects will be randomized to receive either the dietary supplement (1 tablet/day) or placebo (1 tablet/day), both in combination with dietary recommendations, over a treatment period of 12 weeks.

The primary objective is to compare the effect of the tested food supplement versus placebo on LDL-cholesterol after 12 weeks of treatment. Secondary objectives include evaluating changes in LDL-cholesterol at 6 weeks, other lipid fractions, homocysteine, glucose and insulin levels, hsCRP, anthropometric parameters, as well as tolerability and acceptability of the supplement. Safety will be assessed through the collection of adverse events.

Study participation lasts approximately 16 weeks, including screening, diet stabilization run-in, treatment, and follow-up assessments. Outcome measures will be collected at baseline, after 6 weeks, and after 12 weeks of treatment.

Study Overview

• Status: Completed
• Conditions: Dyslipidaemia
• Intervention / Treatment: Other: Placebo; Dietary supplement: NUT2

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Siena
    • Siena, Siena, Italy, 53100
      • Colledoro Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

The subjects will have to meet all the following inclusion criteria:

1. Subjects agree to participate in the study and having dated and signed the informed consent form.
2. Subjects who have the capability to communicate, to make themselves understood, and to comply with the study's requirements.
3. Male or female aged ≥ 18 years and ≤ 70 years old.
4. LDL-Cholesterol plasma levels >115 mg/dL and < 190 mg/dL.
5. TG<400 mg/dL.
6. 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.
7. Patient covered by the Social Security scheme.
8. Pregnancy test.

Exclusion Criteria:

1. Subjects already affected by cardiovascular diseases (secondary prevention) or with estimated 10 years cardiovascular disease risk> 5%;
2. Obesity (BMI>30 kg/m2) or diabetes mellitus;
3. Assumption of lipid lowering drugs or food supplements, or drugs potentially affecting the lipid metabolism;
4. Antihypertensive treatment not stabilized since at least 3 months;
5. Anticoagulants therapy
6. Uncontrolled hypertension (systolic blood pressure> 190 mmHg or diastolic arterial pressure> 100 mmHg);
7. Known current thyroid, gastrointestinal or hepatobiliary diseases;
8. Any medical or surgical condition that would limit the patient adhesion to the study protocol;
9. Abuse of alcohol or drugs (current or previous);
10. History of malignant neoplasia in the 5 years prior to enrolment in the study;
11. 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;
12. History or clinical evidence of any significant concomitant disease that could compromise the safety of the subject or the possibility of completing the study;
13. Known previous intolerance to one component of the tested nutraceuticals
14. Women in fertile age not using consolidated contraceptive methods
15. Pregnancy and Breastfeeding.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Novel food supplement and mediterranean diet	Dietary supplement: NUT2; Food supplement formulated with natural extracts
Placebo Comparator: Placebo and mediterranean diet	Other: Placebo; Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Effect on LDL Cholesterol	12 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Effect on LDL Cholesterol	6 weeks
Effect on Total Cholesterol	12 weeks
Effect on Total Cholesterol	6 weeks
Effect on HDL Cholesterol	12 weeks
Effect on HDL Cholesterol	6 weeks
Effect on Tryglicerides	12 weeks
Effect on Tryglicerides	6 weeks
Effect on Homocysteine	12 weeks
Effect on Homocysteine	6 weeks
Effect on Glycaemia	12 weeks
Effect on Glycaemia	6 weeks
Effect on Insulin	12 weeks
Effect on Insulin	6 weeks
Effect on Body Weight	12 weeks
Effect on Body Weight	6 weeks
Effect on Waist Circumference	12 weeks
Effect on Waist Circumference	6 weeks
Effect on Blood Pressure	12 weeks
Effect on Blood Pressure	6 weeks
Effect on hsCRP	12 weeks
Effect on hsCRP	6 weeks

Collaborators and Investigators

• Sponsor: Cooper Consumer Health
• Collaborators: Meda Pharma S.p.A.

Study record dates

Study Major Dates

• Study Start (Actual): February 21, 2020
• Primary Completion (Actual): December 21, 2020
• Study Completion (Actual): December 21, 2020

Study Registration Dates

• First Submitted: March 10, 2026
• First Submitted That Met QC Criteria: March 23, 2026
• First Posted (Actual): March 25, 2026

Study Record Updates

• Last Update Posted (Actual): March 25, 2026
• Last Update Submitted That Met QC Criteria: March 23, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders; Nutritional and Metabolic Diseases; Dyslipidemias
• Other Study ID Numbers: NUT2-2019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No