Effect of the Level of Dietary Protein on the Infant Hormonal Profile and Body Composition
연구 개요
상세 설명
The primary objective of this clinical trial is to show that infants taking (from birth) either a formula with a low protein content (LoF) or breast milk will have an IGF-1 level, at 4 months, 25% lower to the IGF-1 measured in infants that received a high protein content formula (HiF).
The secondary objectives are: The hormonal profile; the Fat mass (FM) gain and the Lean mass (LM); the metabolomics and aminogramm during the first year of life.
Subjects are included in the study for a duration of 5 years. From birth to 4 months they are exclusively fed BF or FF. From 4 months of age they can start diversification, but they maintain the starter formulas until 12 months (the BF group will receive LoF). Subjects are then followed up until 5 years of age.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Lyon, 프랑스, 69317
- Hôpital de la Croix-Rouse
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
. Healthy newborn infant
- Full term infant (= 37 weeks gestation; = 42 weeks gestation)
- Birth weight = 2500 g and < 4200 g
- Singleton birth
- Infant is = 7 days of age at the time of enrollment
- For the BF group: The infant's mother has elected to exclusively breastfeed her baby, from enrollment to 4 months of age For the FF groups: The infant's mother has elected to exclusively formula feed her baby, from enrollment to 4 months of age
- Having obtained his/her or his/her legal representative's consent
Exclusion Criteria:
Newborn whose mother's BMI was normal (<20 or = 25) at start of pregnancy
- Newborn whose mother had developed gestational diabetes during pregnancy
- Newborn whose mother has diabetes of type-1 or type-2
- Newborn whose mother smoked > 5 cigarettes / day during pregnancy
- Newborn whose mother had a drug dependence during pregnancy
- Newborn whose mother has a chronic infectious disease
- Newborn whose parents / caregivers cannot be expected to comply with treatment
- Newborn currently participating in another clinical trial
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 네 배로
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Group 1: Low protein formula
Low protein formula
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다른 이름들:
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실험적: Group 2: high protein formula
High protein formula
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다른 이름들:
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간섭 없음: Group Breastfeeding
Breastfeeding
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Analysis of IGF-1 value
기간: 4 months
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Analyse the IGF-1 value and compare it
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4 months
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Hormonal profile analysis (Insulin, C-peptide, Glucose, octanoyl ghrelin, Leptin and IGF-1)
기간: 2 weeks, 4 months and 12 months
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The following markers will be measured: Insulin, C-peptide, Glucose, octanoyl ghrelin, Leptin and IGF-1 (IGF-1 at 4 months constitutes the primary outcome of this trial).
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2 weeks, 4 months and 12 months
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DEXA scan as a measure of the body composition
기간: 2 weeks, 4 months and 12 months
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Measure of the Fat Mass (FM) gain and at the variations in Lean Mass (LM) during the first year of age.
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2 weeks, 4 months and 12 months
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aminogramm analysis
기간: 2 weeks, 4 months and 12 months
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amino acids analysis
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2 weeks, 4 months and 12 months
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공동 작업자 및 조사자
수사관
- 연구 책임자: Philippe Steenhout, MD, Société des Produits Nestlé (SPN)
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
- 05.14.INF
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