NCT04483453已完成不适用
Effect of Nutritional Intervention on Metabolic Response in Infants: A Single-Blind, Randomized, Controlled Trial
Société des Produits Nestlé (SPN)2 个研究点 分布在 1 个国家目标入组 102 人开始时间: 2020年7月31日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 102
- 试验地点
- 2
- 主要终点
- Glucose peak
研究概览
简要总结
The purpose of this study is to determine the glucose response of complementary feeding regimens consisting of two different follow-up formulas (FUFs) and infant cereals (ICs).
详细描述
This is a prospective, randomized, single-blind, controlled, 2-arm parallel group trial in infants aged 6 months (26 weeks) at enrollment, who are no longer breastfed, and who are ready but have not yet started complementary feeding. They will be fed one of two different isocaloric feeding regimens (Experimental [EXPL] or Control [CTRL]) consisting of different follow-up formulas (FUFs) and infant cereals (ICs). The main purpose of this study is to determine the glucose response of these two different complementary feeding regimens. All enrolled infants will participate in the trial for approximately 6 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 24 Weeks 至 26 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Written informed consent has been obtained from both parent / liable parent or legally acceptable representative (LAR), if applicable
- •Healthy infant who was singleton, full-term gestational birth (≥ 37 completed weeks of gestation) with a birth weight of ≥ 2.5 kg and ≤ 4.5 kg
- •Infant is no longer breastfeeding or receiving breast milk, has not yet started FUF, and is developmentally ready to begin complementary feeding
- •Infant's parent(s)/guardian is of legal age of consent, must understand the informed consent form and other study documents, and is willing and able to fulfill the requirements of the study protocol.
- •At screening visit (visit 0), infant is 24 - 26 weeks (5½ - 6 months) old
- •Weight-for-height value >-2 standard deviations from the WHO Child Growth Standards median
排除标准
- •Chronic infectious, metabolic, or other disease including any condition that in the opinion of the investigator may impact feeding, growth or adherence to study procedures
- •Major congenital or chromosomal abnormality known to affect growth (e.g., congenital heart disease, cystic fibrosis)
- •Known or suspected cows' milk protein intolerance / allergy, or lactose intolerance, gluten sensitivity or severe food allergies that impact diet
- •Born to mothers with gestational diabetes or type 1 diabetes
- •Major medical/surgical event requiring prolonged hospitalization during the first 6 months
- •Receiving or having received insulin, growth hormone or any other medication known to affect glucose or carbohydrate metabolism or pre- or probiotics known to affect fecal microbiota prior to enrollment
- •Subjects or subjects' parent(s) or legal representative who are not willing and not able to comply with scheduled visits and the requirements of the study protocol
- •Currently participating or having participated in another clinical trial within 4 weeks prior to trial start
结局指标
主要结局
Glucose peak
时间窗: Study days 85-92
Average of the glucose peaks measured by a continuous glucose monitor
次要结局
- Insulin secretion(age 6 months, 9 months, and 12 months)
- Dietary intake(age 6 months, 9 months, and 12 months)
- Stool microbiota composition(age 6 months, 7.5 months, 9 months, and 12 months)
- Body mass index (BMI)(age 6 months, 9 months, and 12 months)
- Weight-for-age z-score(age 6 months, 9 months, and 12 months)
- Weight-for-length z-score(age 6 months, 9 months, and 12 months)
- Head circumference-for-age z-score(age 6 months, 9 months, and 12 months)
- Stool microbiota metabolism(age 6 months, 7.5 months, 9 months, and 12 months)
- Glucose response variability(Study days 85-92)
- Weight(age 6 months, 9 months, and 12 months)
- Length-for-age z-score(age 6 months, 9 months, and 12 months)
- BMI-for-age z-score(age 6 months, 9 months, and 12 months)
- Length(age 6 months, 9 months, and 12 months)
- Stool pH(age 6 months, 7.5 months, 9 months, and 12 months)
- Health-related quality of life(age 6 months, 9 months, and 12 months)
- Glycemic response(Study days 85-92)
- Skinfold thickness(age 6 months, 9 months, and 12 months)
- Head circumference(age 6 months, 9 months, and 12 months)
- Gastrointestinal (GI) tolerance(age 6 months, 9 months, and 12 months)
研究者
研究点 (2)
Loading locations...
相似试验
已完成
不适用
Effect of Nutritional Products in Subjects With Type 2 DiabetesDiabetesNCT02923960Abbott Nutrition43
已完成
不适用
The Effect of Multimodal Nutrition Intervention on Glucose and Lipid Parameters of Arfa Iron and Steel Company WorkersBlood SugarLipid ProfileWeight ChangeNCT06654362Peyman Sarsangi1,097
已完成
不适用
Effect of a Nutritional Approach in Combination With Cognitive Stimulation on Child Cognitive AbilitiesHealthyNCT02359669Société des Produits Nestlé (SPN)200
已完成
不适用
Metabolic Response to Variations in Dietary Glycemic IndexHealthyHungerFood PreferencesNCT05804942Shenzhen Institutes of Advanced Technology ,Chinese Academy of Sciences135
招募中
不适用
The Effects of Dietary Supplements on Glycemic Control, Body Composition and Hepatic Fat Content in People With PrediabetesPreDiabetesNCT06437938Medical University of Vienna50