Colledoro Medical Center
Siena, 53100, Italy
NCT Number: NCT07492264
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.
Looking for future studies?
Notify Me18 year–70 year
All sexes
Interventional
Not applicable
Siena, 53100, Italy
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
The subjects will have to meet all the following inclusion criteria:
Exclusion criteria
Food supplement formulated with natural extracts
Placebo
Time frame: 12 weeks
Time frame: 6 weeks
Time frame: 12 weeks
Time frame: 6 weeks
Time frame: 12 weeks
Time frame: 6 weeks
Time frame: 12 weeks
Time frame: 6 weeks
Time frame: 12 weeks
Time frame: 6 weeks
Time frame: 12 weeks
Time frame: 6 weeks
Time frame: 12 weeks
Time frame: 6 weeks
Time frame: 12 weeks
Time frame: 6 weeks
Time frame: 12 weeks
Time frame: 6 weeks
Time frame: 12 weeks
Time frame: 6 weeks
Time frame: 12 weeks
Time frame: 6 weeks
Cooper Consumer Health
Industry
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.
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.
Published trials that share one or more normalized conditions with this study.
NCT07610304
Dyslipidaemia, Dyslipidemias
Lahore, Pakistan
View Trial DetailsNCT07497776
Dyslipidaemia, Dyslipidemias
Dhaka, Dhaka Division, Bangladesh
View Trial DetailsNCT05979428
Dyslipidaemia, Dyslipidemias
Cypress, California, United States
View Trial DetailsNCT06671405
Dyslipidaemia, Dyslipidemias
Brooklyn, Maryland, United States
View Trial Details