青少年的蛋白质和体重减轻 (POWER)
不同常量营养素成分对肥胖青少年减肥的影响
The aim of the proposed study is to provide important data on weight loss efficacy in overweight and obese adolescents on an isocaloric higher protein diet vs a lower protein diet utilizing the U.S. Department of Agriculture (USDA) MyPlate nutrition guide. The investigators hypothesize that the higher protein diet will result in greater weight loss due to increased satiety and better dietary adherence.
研究概览
详细说明
Aim 1 is to test the efficacy of a personalized higher protein weight loss intervention compared to a lower protein intervention which use the USDA MyPlate nutrition guide.
It is hypothesized that participants randomly assigned to the higher protein dietary treatment will lose more weight based on BMI-Z score over 12 weeks compared to participants in the lower dietary protein treatment.
Aim 2 is to test if changes in subjective ratings of appetite differ by dietary treatment (i.e. protein intake).
It is hypothesized that participants in the higher protein intervention will report a decrease in hunger and an increase in fullness compared to participants in the lower protein intervention.
Aim 3 is to test if change in the hexosamine biosynthetic pathway (HBP) measured at the rate limiting step of glutamine fructose-6-phosphate amidotransferase (GFAT) and glycosylation measured as O-linked N-acetylglucosamine (GlcNAc) transferase (OGT) differ by dietary treatment.
It is hypothesized that participants randomly assigned to the higher protein dietary treatment will have decreased change from baseline levels of GFAT and glycosylation (OGT) due to decreased carbohydrate intake compared to the lower protein treatment.
Exploratory Aims: As exploratory aims, the investigators will test if the higher protein or lower protein dietary treatments differentially alter glucose, insulin, cholesterol, and triglycerides (markers of the metabolic syndrome).
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Louisiana
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Baton Rouge、Louisiana、美国、70808
- Pennington Biomedical Research Center
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Be male or female
- Be between the ages of 12 and 17, inclusive
- Be at or above the 85th BMI percentile (a number calculated from the participants height, weight, sex, and date of birth)
- Be willing to fast for 12 hours prior to clinic study visits 2 and 4
- Be willing to participate in the research study
Exclusion Criteria:
- Health Conditions:
- Has HIV or AIDS
- Has uncontrolled CVD or arrhythmia
- Has Type I or Type II diabetes.
- Is unable or unwilling to complete the study procedures
- Participant may not qualify for this study based on other exclusion criteria not listed. The study coordinator will go over this information in detail.
Medications:
- Diuretics
- Beta-blocker
- Weight loss medications, diet pills
- Anti-inflammatory drugs (corticosteroid/anabolic steroid/NSAID)
- Antipsychotic medications
- Other medications that may affect fluid balance or weight
Lifestyle:
• Plans to move out of the study area within the next 4 months, or plan to be out of the study area for more than 3 weeks during the course of the study.
学习计划
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Higher protein and energy restriction
Participants in this arm will consume 30% of energy as protein with 25% energy restriction. |
Participants will receive an intervention specifically designed for adolescents and their group assignment that relies on nutrition education, nutritional counseling, social cognitive therapy, behavioral strategies, self-monitoring, portion size reduction, and increased physical activity. Participants will get an individualized dietary meal plan. Dietary counseling will be based on the MyPlate guidelines with extra attention and focus on appropriate protein food choice. Also in accordance to the MyPlate guidelines, all participants will be instructed to increase physical activity to 60 minutes a day as aerobic physical activity. The higher protein group will be instructed to consume 30% of energy as protein, with 25% and 45% of energy from fat and carbohydrate, respectively. |
|
实验性的：Lower protein and energy restriction
Participants in this arm will consume 15% of energy as protein with 25% energy restriction. |
Participants will receive an intervention specifically designed for adolescents and their group assignment that relies on nutrition education, nutritional counseling, social cognitive therapy, behavioral strategies, self-monitoring, portion size reduction, and increased physical activity. Participants will get an individualized dietary meal plan. Dietary counseling will be based on the MyPlate guidelines with extra attention and focus on appropriate protein food choice. Also in accordance to the MyPlate guidelines, all participants will be instructed to increase physical activity to 60 minutes a day as aerobic physical activity. The lower protein group will be instructed to consume 15% of energy as protein, with 25% and 60% of energy from fat and carbohydrate, respectively. |
研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
BMI Z 分数
大体时间：至第 12 周
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至第 12 周
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
食欲的主观评分
大体时间：基线和第 12 周
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基线和第 12 周
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Hexosamine Biosynthetic Pathway
大体时间：Baseline and Week 12
|
glutamine fructose-6-phosphate amidotransferase (GFAT) and glycosylation measured as O-linked N-acetylglucosamine (GlcNAc) transferase (OGT) measurement |
Baseline and Week 12
|
其他结果措施
结果测量 |
大体时间 |
|---|---|
|
葡萄糖
大体时间：基线和第 12 周
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基线和第 12 周
|
|
胰岛素
大体时间：基线和第 12 周
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基线和第 12 周
|
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胆固醇
大体时间：基线和第 12 周
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基线和第 12 周
|
|
甘油三酯
大体时间：基线和第 12 周
|
基线和第 12 周
|
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血压
大体时间：基线和第 12 周
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基线和第 12 周
|
合作者和调查者
调查人员
- 首席研究员：John W Apolzan, PhD、Pennington Biomedical
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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