Phase 4 N=52 Randomized Triple-blind Treatment

Effect On Serum Cholesterol Of Dairy Products With Addition Of Esterified Phytosterols

Dyslipidemias · Hypercholesterolemia

Bottom Line

View on ClinicalTrials.gov: NCT02644109 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Aug 2016

Primary outcome: Primary: Serum LDL Cholesterol — 122.2; 113.5 mg/dl

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Phytosterol (Dietary_supplement); Placebo (Dietary_supplement)
Age: Adult, Older Adult · 40+ yrs
Sex: All
Sponsor: University of Chile
Primary completion: Mar 2016

Outcome Measures

Outcome	Result	p-value
PRIMARY Serum LDL Cholesterol	122.2; 113.5	—

Summary

Hypercholesterolemia is an important risk factor for cardiovascular disease, asociated primarily with high plasma levels of LDL lipoprotein, which in turn depend on the endogenous hepatic synthesis of cholesterol and its absorption at intestinal level. It has been demonstrated that there reducing plasma LDL is beneficial, mainly with the use of statins, which are the first treatment option for a moderate hypercholesterolemia. Phytosterols reduce the intestinal absorption of cholesterol by reducing its incorporation into lipid micelles. Consequently, phytosterols have become a relevant alternative treatment against low hypercholesterolemia. The target population are 40 to 65 years old individuals with low hypercholesterolemia.

Eligibility Criteria

Inclusion Criteria

Individuals between 40 to 65 y old.
Males and females.
Body mass index between 20 to 35 kg/m2
Mild hypercholesterolemia (LDL between 130 to 190 mg/dl) without requirement of immediate pharmacological treatment.
Without symptoms of atherosclerotic vascular disease.
Regular consumption of dairy foods (at least once a day).
Sedentary lifestyle defined as less than 20 min, three times per week of moderate to intense physical activity)

Exclusion Criteria

Individuals with sitosterolemia.
Use of hypolipidemic drugs within the past 6 weeks before initiated the study.
Presence of type 1 or 2 diabetes; nephrotic syndrome or chronic kidney disease at stage III (estimated glomerular filtration rate 160 mm/Hg or diastolic>100 mm/Hg), cardiac surgery or other vascularization procedure.
Blood triglycerides higher than 400 mg/dl.
History of cancer disease over the last 5 years.
Pregnant and lactating women.
Lactose intolerant individuals or presence of related symptoms
Individuals with cow´s milk protein allergy.
Vegetarians
Regular use of drugs for obesity treatment, or affecting lipid metabolism.
Regular use of nutritional supplements.
Smokers having more than 5 units per day.
Individuals drinking more than 3 standard units per day of alcoholic beverages (>3 glasses of wine, 2 beers o 1 strong alcohol).

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Data sourced from ClinicalTrials.gov (NCT02644109). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.