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

NCT03563547 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2018-06-20

No results posted yet for this study

Summary

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.

Conditions

  • Heterozygous Familial Hypercholesterolemia

Interventions

BEHAVIORAL

Dietary counseling (fat modifed diet)

Subjects in both groups had been instructed to achieve specific daily maximum intakes in total fat (≤ 30% of total energy intake), saturated fatty acids (≤10% of total fat intake) and cholesterol (≤ 300 mg). Furthermore the participating families had been trained to replace as many visible fat sources as possible with rapeseed oil due to its favorable composition of polyunsaturated fatty acids.

BEHAVIORAL

Dietary Counseling (fat modified + soy enriched diet)

Subjects in both groups had been instructed to achieve specific daily maximum intakes in total fat (≤ 30% of total energy intake), saturated fatty acids (≤10% of total fat intake) and cholesterol (≤ 300 mg). Furthermore the participating families had been trained to replace as many visible fat sources as possible with rapeseed oil due to its favorable composition of polyunsaturated fatty acids. Subjects allocated to the soy group and their families were additionally instructed to consume at least 0.25 g of soy protein per kg bodyweight per day and were provided with recipes and practical advice on how to achieve this goal. Example provided: a child with a bodyweight of 30kg would have to consume the equivalent of approx. 50g of Tofu per day to meet the treatment target.

Sponsors & Collaborators

  • Medical University of Vienna

    collaborator OTHER

  • Austrian Academic Institute for Clinical Nutrition

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
4 Years
Max Age
14 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-09-03
Primary Completion
2014-10-09
Completion
2017-10-09

Countries

  • Austria

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03563547 on ClinicalTrials.gov