Effect of the Level of Dietary Protein on the Infant Hormonal Profile and Body Composition
調査の概要
詳細な説明
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.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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-
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Lyon、フランス、69317
- Hôpital de la Croix-Rouse
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：4倍
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Group 1: Low protein formula
Low protein formula
|
他の名前：
|
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実験的：Group 2: high protein formula
High protein formula
|
他の名前：
|
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介入なし：Group Breastfeeding
Breastfeeding
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Analysis of IGF-1 value
時間枠：4 months
|
Analyse the IGF-1 value and compare it
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4 months
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Hormonal profile analysis (Insulin, C-peptide, Glucose, octanoyl ghrelin, Leptin and IGF-1)
時間枠：2 weeks, 4 months and 12 months
|
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
時間枠：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
時間枠：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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協力者と研究者
捜査官
- スタディディレクター：Philippe Steenhout, MD、Société des Produits Nestlé (SPN)
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- 05.14.INF
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。