Soy Food Intervention Trial (SOYFIT)

June 17, 2009 updated by: Medical University of Vienna

The Soy Food Intervention Trial (SOY FIT) for the Treatment of Children and Adolescents With Familial Hypercholesterolaemia - Beneficial Effect of a Soy-Substituted Diet Confirmed by Assessment of Urinary Isoflavone Excretion as Compliance Markers

Familial hypercholesterolemia (FH MIM#143890), an inherited disorder of lipoprotein metabolism, is a risk for early cardiovascular disease (CVD). This autosomal dominant disease is characterized by markedly elevated plasma concentrations of low density lipoprotein (LDL) and total cholesterol (TC), typically well above the 95th percentile for age and sex (1). A defective gene for the LDL-receptor is inherited from one parent (2). The disorder was first noted by Müller in 1939, including familial clustering of tendon xanthomas, high serum cholesterol and early MIs (3).

The present study aims: a) to strengthen the evidence for the hypocholesterolaemic effect of soy protein in children and adolescents affected with FH b) to monitor the compliance of soy consumption as a possible causal factor linked to the variable lipaemic response observed in the previous study c) to assess certain safety markers of soy food consumption (hormone status, thyroid function, bone metabolism) 4) to monitor the adherence to the soy intervention additionally comprise collections of blood and urine samples.

Hypothesis 1: Soya protein-substituted diets change total and LDL-cholesterol, Apolipoprotein B and uric acid serum concentrations.

Primary parameters: Blood analysis

Hypothesis 2: Children and adolescents with FH, in which the cholesterol, LDL-lipoprotein and Apolipoprotein B concentration is not influenced by means of soy protein substituted diet - is it because of a) the effect of non-responder? or b) subjects, who have no regularly dietary soya intake.

Secondary parameters: isoflavones daidzein, glycetein, genistein and equol in the urine samples

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The pilot study will include 30 children and adolescents with heterozygous Familial Hypercholesterolemia. All children and adolescents will be recruited from the Paediatrics Outpatient Department of the Division of Clinical Nutrition and Metabolism at the Vienna University Hospital. Furthermore, children of patients with heart stroke, patients from other paediatrics and patients from other children hospitals will be recruited. Inclusion criteria: To be eligible the study participants will have to be aged between 4 and 18 years, do not regularly eat soy food and do not have a protein allergy. The participants are recruited by their familial history and/or their cholesterol levels (elevated over 130 mg/dl and total cholesterol elevated over 200 mg/dl) according to American Academy of Paediatrics criteria. Furthermore they should keep a 7-day nutrition record at the beginning of study. Exclusion criteria: Patients younger than 4 years and older than 18 years, children who are extremely underweight according to Kromeyer Hausschild´s criteria. Children and adolescents with mental disability and with simultaneous medication and protein allergy. Complete physical information will be done and a thorough medical history will be taken in all participants. Physical examination and blood sampling will be performed in the outpatient clinic setting as done routinely.

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Vienna, Austria, 1090
        • Division of Nutrition and Metabolism, Department of Pediatrics, Medical University of Vienna

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • To be eligible the study participants will have to be aged between 4 and 18 years,
  • do not regularly eat soy food and do not have a protein allergy.
  • the participants are recruited by their familial history and/or their cholesterol levels (elevated over 130 mg/dl and total cholesterol elevated over 200 mg/dl) according to American Academy of Paediatrics criteria

Exclusion Criteria:

  • Patients younger than 4 years and older than 18 years,
  • children who are extremely underweight according to Kromeyer Hausschild´s criteria.
  • Children and adolescents with mental disability and with simultaneous medication and protein allergy.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Rapeseed oil
Control-Group (n = 15) : Diet reduced in SFA, modified in fatty acid pattern. Only rapeseed oil should to be used for preparation of the meals (baking, frying, in salad, and as spread.
Dietary supplement: rapeseed oil
Control-Group (n = 15): Diet reduced in SFA, modified in fatty acid pattern. Only rapeseed oil should to be used for preparation of the meals (baking, frying, in salad, and as spread.
Experimental: Soy protein diet
Intervention-Group (n = 15): Fat- modified dietary regime and a minimum amount of soy protein: 0,25 g/ kg BW/d
Dietary supplement: soy protein diet
Intervention-Group (n = 15): Fat- modified dietary regime and a minimum amount of soy protein: 0,25 g/ kg BW/d

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Blood analysis include: TC, LDLc, HDLc, TG, Lp(a), ApoA1, Apo B, Electrolytes, Albumin, Creatinin and CRP
Time Frame: done in Phase 1: 1st week, Phase 2: 7th week, Phase 3: 13th week
done in Phase 1: 1st week, Phase 2: 7th week, Phase 3: 13th week

Secondary Outcome Measures

Outcome Measure
Time Frame
uric acid and the isoflavones: daidzein, glycetein, genistein and equol
Time Frame: done in Phase 1: 1st week, Phase 2: 3rd, 5th, 7th, 9th, 11th week, Phase 3: 13th week
done in Phase 1: 1st week, Phase 2: 3rd, 5th, 7th, 9th, 11th week, Phase 3: 13th week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Vienna

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2009

Primary Completion (Anticipated)

March 1, 2011

Study Completion (Anticipated)

September 1, 2011

Study Registration Dates

First Submitted

May 28, 2009

First Submitted That Met QC Criteria

June 17, 2009

First Posted (Estimate)

June 18, 2009

Study Record Updates

Last Update Posted (Estimate)

June 18, 2009

Last Update Submitted That Met QC Criteria

June 17, 2009

Last Verified

June 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SOYFIT

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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