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
연구 개요
상세 설명
연구 유형
등록 (예상)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Vienna, 오스트리아, 1090
- Division of Nutrition and Metabolism, Department of Pediatrics, Medical University of Vienna
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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위약 비교기: 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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실험적: 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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
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Blood analysis include: TC, LDLc, HDLc, TG, Lp(a), ApoA1, Apo B, Electrolytes, Albumin, Creatinin and CRP
기간: 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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2차 결과 측정
결과 측정 |
기간 |
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uric acid and the isoflavones: daidzein, glycetein, genistein and equol
기간: 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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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (예상)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
- SOYFIT
약물 및 장치 정보, 연구 문서
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rapeseed oil에 대한 임상 시험
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