NCT03563547: SOYFIT

Effects of Soy Protein on Cholesterol Levels in Children Affected With Familial Hypercholesterolemia

Completed NA Last updated 20 June 2018

What this trial tests

NA trial testing Dietary counseling (fat modifed diet) in Heterozygous Familial Hypercholesterolemia in 34 participants. Completed in 9 October 2017.

Timeline

3 September 2009

Primary endpoint
9 October 2014

9 October 2017

Quick facts

Lead sponsor	Austrian Academic Institute for Clinical Nutrition
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	34
Start date	3 September 2009
Primary completion	9 October 2014
Estimated completion	9 October 2017
Sites	1 location across Austria

Drugs / interventions tested

• Dietary counseling (fat modifed diet)
• Dietary Counseling (fat modified + soy enriched diet)

Conditions studied

• Heterozygous Familial Hypercholesterolemia — all drugs for Heterozygous Familial Hypercholesterolemia →

Sponsor

Austrian Academic Institute for Clinical Nutrition

Who can join

Adults 4 to 14, any sex, with Heterozygous Familial Hypercholesterolemia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Familial hypercholesterolemia (FH) is an inheritable, autosomal dominant disorder leading to pathologically increased levels of low-density-lipoprotein cholesterol (LDL-C). Dietary treatment remains an important tool in the management of affected children even after the decision for the initiation of pharmacotherapy is made. However, little evidence is available on the beneficial effects of diets low in saturated fat and cholesterol and diets enriched with soy in children affected with FH. Based on these previous findings we hypothesize that the LDL-C lowering effect of a fat-modified diet could be further increased by the addition of soy-protein in children affected with HeFH.

Publications & conference data

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

1. Effects of a low-fat dietary regimen enriched with soy in children affected with heterozygous familial hypercholesterolemia.
   Helk O, Widhalm K. · · 2020 · cited 17× · PMID 32220359 · DOI 10.1016/j.clnesp.2019.09.009