- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01487889
Polyunsaturated Fatty Acids in Child Nutrition (PINGU)
Polyunsaturated Fatty Acids in Child Nutrition - A German Multimodal Optimisation Study
Primary objective of this study is to examine the effects of 2 different approaches of dietary strategies to optimise fatty acid composition in complementary food on infant's fatty acid status and its consequences on cognitive and visual development.
Subjects are randomly assigned to one of three groups:
- Rapeseed oil (high in n-3 PUFA and small n-6:n-3 ratio to support endogenous n- 3 LC-PUFA metabolism)
- Fatty fish (preformed n-3 LC-PUFA, especially DHA)
- Corn oil (as control group, high in n-6 PUFA, common in complementary food).
The intervention starts with the beginning of complementary feeding as generally recommended between 4 to 6 months of age and ends at the age of 10 months. For this period of time subjects of all groups receive commercial vegetable-potato-meat-meals as part of complementary food which only differs in the fatty acid composition.
연구 개요
상세 설명
A well balanced supply of polyunsaturated fatty acids, in particular the omega-3 long chain docosahexaenoic acid (DHA), in early childhood is essential for children's cognitive and visual development. DHA can either be supplied preformed in the diet (e.g. via fatty fish) or synthesised by conversion of its essential precursor alpha-linolenic acid (e.g. via rapeseed oil). The study examines the effect of two different approaches to optimise infants´ fatty acid status.
The study sample consists of healthy newborns and their mothers (3 x 57 infants according to a priori power calculation) who are enrolled in delivery hospitals in the region of Dortmund, Germany. In total, the individual study program covers the first 10 months of infant's life. Biomarkers of fatty acid status from the mother are collected 8 weeks pp for the estimation of pre- and perinatal fatty acid supply. Additionally, information on maternal diet during pregnancy and after delivery is assessed. The intervention covers the period of complementary feeding (from 4 to 6 months of age until 10 months of age). In all groups the specific study food is given 5 to 7 times a week, whereas 2 of these are fish meals in the fatty fish group. At the age of 4 and 10 months blood samples are collected from the infants to examine the effect on blood fatty acid status. Parameters of visual and cognitive development are also assessed at the age of 4 and 10 months using VEP examinations and Bayley scales. Infants´ dietary intake is assessed from the end of the 2 months until 10 months of age using continuous weighed dietary records.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Dortmund, 독일, 44225
- Research Institute of Child Nutrition
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- a term healthy newborn infant ( birth weight > 2500 g, gestational age > 37 weeks
- German speaking mother
- the intention of the mother to breast-feed the children and to feed study menus at least 5 times per week beginning in the fifth to seventh month of life.
Exclusion Criteria:
- preterm children
- twins
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 네 배로
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Rapeseed oil
Study group receive commercial vegetable-potato-meat-meals containing rapeseed oil as part of complementary food
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Groups receive commercial vegetable-potato-meat-meals as part of complementary food which differs in the fatty acid composition
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실험적: Fatty fish
Study group receive 2 times per week a vegetable-potato-meat-meals as part of complementary food.
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Groups receive commercial vegetable-potato-meat-meals as part of complementary food which differs in the fatty acid composition
|
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활성 비교기: Corn oil
Study group receive commercial vegetable-potato-meat-meals containing corn oil as part of complementary food
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Groups receive commercial vegetable-potato-meat-meals as part of complementary food which differs in the fatty acid composition
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Infants´ fatty acid status
기간: 10 months after delivery
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Fatty acids (saturated fatty acids, monounsaturated fatty acids, polyunsaturated fatty acids including long-chain polyunsaturated fatty acids) are measured in percent of total fatty acids in erythrocyte membranes, whole plasma, and cheek cells in order to assess the fatty acid composition.
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10 months after delivery
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Infants´ visual development
기간: 10 months after delivery
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Infants´ visual development is assessed using the visual evoked potentials method.
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10 months after delivery
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Infants´ cognitive development
기간: 10 months after delivery
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Infants´ cognitive development is assessed using the Bayley II scale.
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10 months after delivery
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Infants´ haemogram
기간: 10 months after delivery
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10 months after delivery
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Infants´antioxidant status
기간: 10 months after delivery
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10 months after delivery
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Infants´ body weight
기간: 10 months after delivery
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10 months after delivery
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Infants´ dietary intake
기간: from 2 until 10 months after delivery
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from 2 until 10 months after delivery
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Maternal dietary intake
기간: pregnancy and first 2 months post partum
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pregnancy and first 2 months post partum
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Infant's preference for fish
기간: 10 month after delivery
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10 month after delivery
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Infant's preference for new flavour
기간: 10 month after delivery
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10 month after delivery
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Parental attitudes about fish and feeding strategies
기간: 10 months after delivery
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10 months after delivery
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Mother´s fatty acid status
기간: 2 months after delivery
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Fatty acids (saturated fatty acids, monounsaturated fatty acids, polyunsaturated fatty acids including long-chain polyunsaturated fatty acids) are measured in percent of total fatty acids in erythrocyte membranes, whole plasma, cheek cells, and breast milk in order to assess the fatty acid composition.
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2 months after delivery
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Infants´ body length
기간: 10 months after delivery
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10 months after delivery
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Infant´s head circumference
기간: 10 months after delivery
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10 months after delivery
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공동 작업자 및 조사자
협력자
수사관
- 연구 책임자: Mathilde Kersting, Professor, Research Institute of Child Nutrition
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
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
기타 연구 ID 번호
- PINGU0911DO
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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