NCT07492264

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.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 90 (actual)
• Sponsor: Cooper Consumer Health · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Dyslipidaemia

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	NUT2	Food supplement formulated with natural extracts
OTHER	Placebo	Placebo

Timeline

• Start date: 2020-02-21
• Primary completion: 2020-12-21
• Completion: 2020-12-21
• First posted: 2026-03-25
• Last updated: 2026-03-25

Locations

1 site across 1 country: Italy