NCT04148976

Effect of Dietary Intervention on LDL-C and Lipoprotein Subclasses Distribution in Patients With Hypercholesterolemia

Completed NA Last updated 6 November 2019

What this trial tests

NA trial testing Placebo in Hypercholesterolemia in 62 participants. Completed in 18 December 2018.

Timeline

28 February 2013

Primary endpoint
18 December 2018

18 December 2018

Quick facts

Lead sponsor	Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	62
Start date	28 February 2013
Primary completion	18 December 2018
Estimated completion	18 December 2018

Drugs / interventions tested

• Placebo
• Dietary portfolio

Conditions studied

• Hypercholesterolemia — all drugs for Hypercholesterolemia →
• Disease — all drugs for Disease →
• Dyslipidemias — all drugs for Dyslipidemias →

Sponsor

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran — full company profile →

Who can join

Adults 20 to 60, any sex, with Hypercholesterolemia or Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The primary aim of the present study was to elucidate the effect of a combination of functional foods on the low-density lipoprotein cholesterol (LDL-C) levels and on the distribution of the lipoprotein subclasses in subjects with hypercholesterolemia. To accomplish the latter, subjects that met the inclusion criteria and had mild hypercholesterolemia (Total cholesterol \>200mg/dL, and LDL-C \>130mg/dL \<190 mg/dL) were recruited for double-blind, parallel, controlled dietary intervention study. After two weeks of dietary standardization with an isocaloric diet, subjects were randomized and allocated to either placebo or a dietary portfolio treatment for two months. The secondary endpoints were the size of the different lipoprotein subclasses, total cholesterol levels, high density -lipoprotein cholesterol (HDL-C) levels, apolipoprotein B, triglycerides, total/HDL-C ratio, apolipoprotein B/apolipoprotein A ratio, and anthropometric measurements.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Effect of a dietary intervention with functional foods on LDL-C concentrations and lipoprotein subclasses in overweight subjects with hypercholesterolemia: Results of a controlled trial.
   Vázquez-Manjarrez N, Guevara-Cruz M, Flores-López A, Pichardo-Ontiveros E, et al · · 2021 · cited 2× · PMID 33932799 · DOI 10.1016/j.clnu.2021.02.048