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

NCT03563547 | Completed

• 1 other identifier: SoyfitKW01
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

LDL-Cholesterol; Heterozygous Familial Hypercholesterolemia; Paediatrics; Dietary Treatment

Outcome Measures

Primary Outcomes (1)

• LDL-C change from baseline

  13 weeks

Study Arms (2)

Fat modified diet

ACTIVE COMPARATOR

Subjects in this arm 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 modifed diet)

Fat modifed diet enriched with soy protein

EXPERIMENTAL

Subjects in this arm 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 in this arm 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.

Behavioral: Dietary Counseling (fat modified + soy enriched diet)

Interventions

Dietary counseling (fat modifed diet) BEHAVIORAL

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.

Fat modified diet

Dietary Counseling (fat modified + soy enriched diet) BEHAVIORAL

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.

Fat modifed diet enriched with soy protein

Eligibility Criteria

• Age: 4 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Informed consent of both the patient and their legal guardian, age of 4 to 14, diagnosis of definite FH using the Simon Broome criteria, body weight within normal age-specific percentile range (Kromeyer-Hauschild et al.), the proven ability and willingness to adhere to a fat-modified diet.

You may not qualify if:

• Metabolic or genetic disorders other than FH, current infectious disease, current or history of cancerous disease, current treatment with lipid lowering drugs, failure to complete all trial-related assessments, reported habit of consuming soy products or adherence to a non-standard diet (e.g. vegetarianism) prior to enrolment into the study.

Sponsors & Collaborators

• Austrian Academic Institute for Clinical Nutrition: lead
• Medical University of Vienna: collaborator

Study Sites (1)

Austrian Academic Institute for Clinical Nutrition

Vienna, 1090, Austria

Location

Related Publications (1)

• Helk O, Widhalm K. Effects of a low-fat dietary regimen enriched with soy in children affected with heterozygous familial hypercholesterolemia. Clin Nutr ESPEN. 2020 Apr;36:150-156. doi: 10.1016/j.clnesp.2019.09.009. Epub 2020 Jan 31.

  PMID: 32220359 DERIVED

MeSH Terms

Interventions

Nutrition Assessment

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2018
• First Posted: June 20, 2018
• Study Start: September 3, 2009
• Primary Completion: October 9, 2014
• Study Completion: October 9, 2017
• Last Updated: June 20, 2018

Record last verified: 2018-06

Locations

AU (1)