Soy Food Intervention Trial (SOYFIT)
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
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Type d'étude
Inscription (Anticipé)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Vienna, L'Autriche, 1090
- Division of Nutrition and Metabolism, Department of Pediatrics, Medical University of Vienna
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La 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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Comparateur placebo: 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.
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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.
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Expérimental: Soy protein diet
Intervention-Group (n = 15): Fat- modified dietary regime and a minimum amount of soy protein: 0,25 g/ kg BW/d
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Intervention-Group (n = 15): Fat- modified dietary regime and a minimum amount of soy protein: 0,25 g/ kg BW/d
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
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Blood analysis include: TC, LDLc, HDLc, TG, Lp(a), ApoA1, Apo B, Electrolytes, Albumin, Creatinin and CRP
Délai: done in Phase 1: 1st week, Phase 2: 7th week, Phase 3: 13th week
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done in Phase 1: 1st week, Phase 2: 7th week, Phase 3: 13th week
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Mesures de résultats secondaires
Mesure des résultats |
Délai |
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uric acid and the isoflavones: daidzein, glycetein, genistein and equol
Délai: done in Phase 1: 1st week, Phase 2: 3rd, 5th, 7th, 9th, 11th week, Phase 3: 13th week
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done in Phase 1: 1st week, Phase 2: 3rd, 5th, 7th, 9th, 11th week, Phase 3: 13th week
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Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Anticipé)
Achèvement de l'étude (Anticipé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- SOYFIT
Informations sur les médicaments et les dispositifs, documents d'étude
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Étudie un produit d'appareil réglementé par la FDA américaine
produit fabriqué et exporté des États-Unis.
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