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临床试验/NCT05464186
NCT05464186招募中不适用

Effects of Whole vs. Nonfat Milk Consumption on Body Composition in Children: a 1-Year RCT

Boston Children's Hospital1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2022年12月28日最近更新:
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适应症

试验速览

阶段
不适用
状态
招募中
入组人数
200
试验地点
1
主要终点
Fat mass
研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This study will evaluate the effects of whole vs. nonfat milk consumption on body composition, cardiometabolic disease risk factors, and dietary quality.

详细描述

Background The optimal type of milk is a topic of much debate. Several recent observational studies indicate that consuming whole (full-fat), compared to reduced-fat milk, is associated with less weight gain and decreased cardiometabolic disease risk. The observed beneficial effect of consuming whole milk on body weight may be due to its greater satiety value, leading to consumption of fewer calories from other lower quality (e.g., sugary) foods. Mechanistic studies indicate that substitution of carbohydrate with certain saturated fatty acids in milk increases low-density lipoprotein cholesterol (LDL-C). However, this increase has been attributed to large, buoyant particles that are less atherogenic than small, dense particles; is accompanied by an increase in high-density lipoprotein cholesterol (HDL-C); and may not elevate overall risk compared to carbohydrate.

Specific Aims and Hypotheses

  • To examine the effects of milk consumption on body composition (Aim #1) and cardiometabolic disease risk factors (Aim #2). Primary Hypothesis. Consuming whole milk will result in less weight gain compared to consuming nonfat milk. Secondary hypothesis. Consuming whole milk will decrease cardiometabolic disease risk compared to consuming nonfat milk.
  • To explore the effects of milk consumption on dietary quality (Aim #3). Exploratory hypothesis. Consuming whole milk will improve overall dietary quality by displacing lower quality foods compared to consuming nonfat milk, particularly among children with low baseline dietary quality.
  • (Ancillary Study) To evaluate the effects of milk consumption on risk and prevalence of dental caries.

Design Randomized Controlled Trial. Participants (N=200, aged 9 to 12 years, BMI≥75th percentile) will be randomly assigned for 1 year to receive: 1) Whole milk, 3 cups/d or 2) Nonfat milk, 3 cups/d. To promote adherence to the interventions, the investigators will rely on home delivery of milk using methods consistent with previous successful studies.

Study Outcomes The primary outcome is change in fat mass measured by air displacement plethysmography (BodPod) at 3 time points (baseline and 6 and 12 months). To evaluate cardiometabolic disease risk factors, the investigators will obtain a plasma MetaboProfile®(LabCorp) that includes lipoprotein particle sizes and subfraction concentrations, novel measures of insulin-resistant dyslipoproteinemia and inflammation, and a conventional lipid profile. The investigators will also measure blood pressure.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
9 Years 至 12 Years（Child）
性别
All
接受健康志愿者
是

入选标准

  • •Aged 9 to 12 years
  • •BMI ≥75th percentile for sex and age
  • •Residence in the Greater Boston catchment area

排除标准

  • •Aversion to nonfat or whole milk
  • •Physician diagnosis of major medical illness, eating disorder, or milk allergy (lactose intolerance not exclusionary as lactase treated milk can be provided)
  • •Plans to move away from the Greater Boston catchment area during the study period
  • •Plans to be away from home for ≥5 weeks during the study period (e.g., extended summer vacation)
  • •Change in body weight exceeding 10% during prior year
  • •Recent adherence to a special diet
  • •Chronic use of any medication or dietary supplement that could affect study outcomes
  • •Another member of the family (first degree relative) or household participating in the study

结局指标

主要结局

Fat mass

时间窗: Change from start of trial (time of randomization) through end of trial (12 months)

Primary outcome for the overall study, main outcome for Specific Aim #1, measured by air displacement plethysmography (BodPod)

次要结局

  • High-density lipoprotein cholesterol (HDL-C)(Change from start of trial (time of randomization) through end of trial (12 months))
  • Low-density lipoprotein cholesterol (LDL-C)(Change from start of trial (time of randomization) through end of trial (12 months))
  • Glucose(Change from start of trial (time of randomization) through end of trial (12 months))
  • Systolic blood pressure(Change from start of trial (time of randomization) through end of trial (12 months))
  • Diastolic blood pressure(Change from start of trial (time of randomization) through end of trial (12 months))
  • Height(Change from start of trial (time of randomization) through end of trial (12 months))
  • Body mass index (BMI)(Change from start of trial (time of randomization) through end of trial (12 months))
  • Leptin(Change from start of trial (time of randomization) through end of trial (12 months))
  • Ghrelin(Change from start of trial (time of randomization) through end of trial (12 months))
  • Insulin-like growth factor-1 (IGF-1)(Change from start of trial (time of randomization) through end of trial (12 months))
  • Insulin-like growth factor-binding protein 3 (IGF-BP3)(Change from start of trial (time of randomization) through end of trial (12 months))
  • High-density lipoprotein particle (HDL-P) size(Change from start of trial (time of randomization) through end of trial (12 months))
  • Low-density lipoprotein particle (LDL-P) size(Change from start of trial (time of randomization) through end of trial (12 months))
  • Sum of large and very large TRL-P concentration(Change from start of trial (time of randomization) through end of trial (12 months))
  • Large HDL-P concentration(Change from start of trial (time of randomization) through end of trial (12 months))
  • Small LDL-P concentration(Change from start of trial (time of randomization) through end of trial (12 months))
  • Large LDL-P concentration(Change from start of trial (time of randomization) through end of trial (12 months))
  • Triglycerides (TG)(Change from start of trial (time of randomization) through end of trial (12 months))
  • Insulin(Change from start of trial (time of randomization) through end of trial (12 months))
  • Insulin resistance(Change from start of trial (time of randomization) through end of trial (12 months))
  • Adiponectin - total and high molecular weight(Change from start of trial (time of randomization) through end of trial (12 months))
  • Hemoglobin A1c (HgA1c)(Change from start of trial (time of randomization) through end of trial (12 months))
  • High-sensitivity C-reactive protein (hsCRP)(Change from start of trial (time of randomization) through end of trial (12 months))
  • Interleukin-6 (IL-6)(Change from start of trial (time of randomization) through end of trial (12 months))
  • Fibrinogen(Change from start of trial (time of randomization) through end of trial (12 months))
  • Plasminogen activator inhibitor-1 (PAI-1)(Change from start of trial (time of randomization) through end of trial (12 months))
  • Lean body mass(Change from start of trial (time of randomization) through end of trial (12 months))
  • Lipoprotein insulin resistance (LPIR)(Change from start of trial (time of randomization) through end of trial (12 months))
  • Triglyceride-rich lipoprotein particle (TRL-P) size(Change from start of trial (time of randomization) through end of trial (12 months))
  • Percent body fat(Change from start of trial (time of randomization) through end of trial (12 months))
  • Lean body mass(Change from start of trial (time of randomization) through end of trial (12 months))
  • Percent body fat(Change from start of trial (time of randomization) through end of trial (12 months))
  • Height(Change from start of trial (time of randomization) through end of trial (12 months))
  • Body mass index (BMI)(Change from start of trial (time of randomization) through end of trial (12 months))
  • Leptin(Change from start of trial (time of randomization) through end of trial (12 months))
  • Ghrelin(Change from start of trial (time of randomization) through end of trial (12 months))
  • Insulin-like growth factor-1 (IGF-1)(Change from start of trial (time of randomization) through end of trial (12 months))
  • Insulin-like growth factor-binding protein 3 (IGF-BP3)(Change from start of trial (time of randomization) through end of trial (12 months))
  • Lipoprotein insulin resistance (LPIR)(Change from start of trial (time of randomization) through end of trial (12 months))
  • Triglyceride-rich lipoprotein particle (TRL-P) size(Change from start of trial (time of randomization) through end of trial (12 months))
  • High-density lipoprotein particle (HDL-P) size(Change from start of trial (time of randomization) through end of trial (12 months))
  • Low-density lipoprotein particle (LDL-P) size(Change from start of trial (time of randomization) through end of trial (12 months))
  • Sum of large and very large TRL-P concentration(Change from start of trial (time of randomization) through end of trial (12 months))
  • Large HDL-P concentration(Change from start of trial (time of randomization) through end of trial (12 months))
  • Small LDL-P concentration(Change from start of trial (time of randomization) through end of trial (12 months))
  • Large LDL-P concentration(Change from start of trial (time of randomization) through end of trial (12 months))
  • Triglycerides (TG)(Change from start of trial (time of randomization) through end of trial (12 months))
  • High-density lipoprotein cholesterol (HDL-C)(Change from start of trial (time of randomization) through end of trial (12 months))
  • Low-density lipoprotein cholesterol (LDL-C)(Change from start of trial (time of randomization) through end of trial (12 months))
  • Glucose(Change from start of trial (time of randomization) through end of trial (12 months))
  • Insulin(Change from start of trial (time of randomization) through end of trial (12 months))
  • Insulin resistance(Change from start of trial (time of randomization) through end of trial (12 months))
  • Adiponectin - total and high molecular weight(Change from start of trial (time of randomization) through end of trial (12 months))
  • Hemoglobin A1c (HgA1c)(Change from start of trial (time of randomization) through end of trial (12 months))
  • High-sensitivity C-reactive protein (hsCRP)(Change from start of trial (time of randomization) through end of trial (12 months))
  • Interleukin-6 (IL-6)(Change from start of trial (time of randomization) through end of trial (12 months))
  • Fibrinogen(Change from start of trial (time of randomization) through end of trial (12 months))
  • Plasminogen activator inhibitor-1 (PAI-1)(Change from start of trial (time of randomization) through end of trial (12 months))
  • Systolic blood pressure(Change from start of trial (time of randomization) through end of trial (12 months))
  • Diastolic blood pressure(Change from start of trial (time of randomization) through end of trial (12 months))
  • Salivary cariogenicity(Change from start of trial (time of randomization) through end of trial (12 months))
  • Caries prevalence(Difference between start of trial (time of randomization) and end of trial (12 months))
  • Serum 25-hydroxyvitamin D [25(OH)D](Change from start of trial (time of randomization) through end of trial (12 months))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Cara B Ebbeling

Co-Director, New Balance Foundation Obesity Prevention Center; Associate Professor of Pediatrics

Boston Children's Hospital

研究点 (1)

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