CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 62 enrolled
Drug / intervention
Placebo +1 moredietary
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04148976
NCT04148976N/ACompleted

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

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran·interventional·Posted Nov 4, 2019·Updated Nov 6, 2019

In Brief

A clinical study evaluating Placebo and Dietary portfolio for Hypercholesterolemia and 2 related conditions. Completed, enrolled 62 participants.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
Countries--
Collaborators--

Timeline

N/ACompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedNov 4, 2019
Enrollment StartFeb 28, 2013
Primary CompletionDec 18, 2018
TodayJul 2, 2026
Enrollment to primary: 5.8 yearsPosted 6.7 years ago

Interventions

Placebodietary

A mixture of maltodextrins and calcium caseinate divided into 30g individual packets.

Dietary portfoliodietary

A mixture of functional foods divided into 30g individual packets.