Soy Food Intervention Trial (SOYFIT)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2009 by Medical University of Vienna.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT00924339
First received: May 28, 2009
Last updated: June 17, 2009
Last verified: June 2009
  Purpose

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


Condition Intervention
Familial Hypercholesterolemia
Dietary Supplement: soy protein diet
Dietary Supplement: rapeseed oil

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Medical University of Vienna:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 30
Study Start Date: September 2009
Estimated Study Completion Date: September 2011
Estimated Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   4 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00924339

Locations
Austria
Division of Nutrition and Metabolism, Department of Pediatrics, Medical University of Vienna Not yet recruiting
Vienna, Austria, 1090
Contact: Alexandra Kreißl, Mag.rer.nat    0034140400 ext 2051    alexandra.kreissl@meduniwien.ac.at   
Principal Investigator: Alexandra Kreißl, Mag.rer.nat         
Sponsors and Collaborators
Medical University of Vienna
  More Information

No publications provided

Responsible Party: Prof. Kurt Widhalm, Division Nutrition and Metabolism, Department of Pediatrics
ClinicalTrials.gov Identifier: NCT00924339     History of Changes
Other Study ID Numbers: SOYFIT
Study First Received: May 28, 2009
Last Updated: June 17, 2009
Health Authority: Austria: Ethikkommission

Keywords provided by Medical University of Vienna:
soy protein
familial hypercholesterolaemia
children and adolescents
isoflavones
FH

Additional relevant MeSH terms:
Hypercholesterolemia
Hyperlipoproteinemia Type II
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Lipid Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Hyperlipoproteinemias

ClinicalTrials.gov processed this record on August 28, 2014