- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT00924339
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
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
Studietyp
Inskrivning (Förväntat)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
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Vienna, Österrike, 1090
- Division of Nutrition and Metabolism, Department of Pediatrics, Medical University of Vienna
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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.
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
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Placebo-jämförare: 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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Experimentell: 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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Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
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Blood analysis include: TC, LDLc, HDLc, TG, Lp(a), ApoA1, Apo B, Electrolytes, Albumin, Creatinin and CRP
Tidsram: 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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Sekundära resultatmått
Resultatmått |
Tidsram |
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uric acid and the isoflavones: daidzein, glycetein, genistein and equol
Tidsram: 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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Samarbetspartners och utredare
Sponsor
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Förväntat)
Avslutad studie (Förväntat)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- SOYFIT
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