Impact of High Fiber Snacks on Adiposity, Glucose Regulation and Appetite
2017年8月9日 更新者:Dr. Shirin Hooshmand、San Diego State University
Impact of High Fiber Snacks on Adiposity, Glucose Regulation and Appetite in Children
The primary objective of the proposed research is to determine the influence of 8 weeks of twice daily consumption of 120 kcal servings of dried apples or a commonly consumed low fat 120kcal muffin on components of obesity (waist circumference [waist measurement], serum glucose [blood sugar], triglycerides [fats in the blood] and HDL-cholesterol, and blood pressure) as well as antioxidant status, inflammatory markers, nutrient intake in overweight and obese individuals.
A total of 48 children aged 10-16 years will be randomly assigned to groups and provided with twice daily 120 kcal servings of either dried apples or muffins for 8 weeks of feeding.
Prior to initiating the feeding trial and again after 8 weeks, blood samples will be collected and analyzed.
During each visit to the lab, subjects will be weighed in minimal clothing, tested for body composition using dual energy X-ray absorptiometry (DXA), bioelectrical impedance (BIA) and air displacement plethysmography (Bod Pod) and blood pressure, and measured for waist circumference.
One 24-hour recall will be performed prior to initiation of the study; one recall will be performed throughout the feeding period, and one at the end of the 8 weeks.
Dietary intake of energy, macronutrients, vitamins and minerals will be assessed to determine diet quality.
All food records will be analyzed using the Nutritionist Pro (First DataBank) software.
The potential benefits of the study include determining the effects of consistent snacking and particular snack foods on metabolism and weight management.
There are no major risks to subjects in this study.
There are minimal risks when performing venipuncture (blood draws) including bruising, perforation of the vein leading to hematoma under skin, light-headedness or dizziness due to fear of needles, and infection.
This study will hopefully allow more understanding and insight into the diet of children and the effect of it on body makeup and blood sugar.
It is hypothesized that the twice a day apple snack group will have decreased waist circumference, body adiposity, triglycerides and total cholesterol as well as, increased blood glucose uptake at the end of 8 weeks.
研究概览
研究类型
介入性
注册 (实际的)
45
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习地点
-
-
California
-
San Diego、California、美国、92182
- San Diego State Univeristy
-
-
参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
10年 至 16年 (孩子)
接受健康志愿者
是的
有资格学习的性别
全部
描述
Inclusion Criteria:
- must be between age 10-16
- must be overweight or obese according to growth charts
Exclusion Criteria:
- regular consumers of apples (one per day)
- supplement users other than multivitamin
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 主要用途:基础科学
- 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:Apple group
twenty four participants will be randomly selected for the apple group, in which they will receive 37.5 grams equal to 120kcal of dried apples twice a day for eight weeks.
This snack of apples will be eaten once between breakfast and lunch and once between lunch and dinner and both will be consumed with an eight ounce bottle of water.
|
120 calories
|
|
安慰剂比较:Muffin control
twenty four participants will be randomly selected to make up the muffin control group, in which one 120kcal muffin control snack will be consumed twice each day for eight weeks.
The muffin control will be consumed one between breakfast and lunch and one between lunch and dinner, each snack will be consumed with an eight ounce bottled water.
|
120 calories
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change from baseline Body Composition at 8 weeks
大体时间:baseline, 8 weeks
|
Height, Weight, waist circumference, Body Mass Index are all used to asses body composition.
Bod pod, BIA, and Dexa are also used to obtain the body composition.
|
baseline, 8 weeks
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change from baseline of triglycerides at 8 weeks
大体时间:baseline, 8 weeks
|
baseline, 8 weeks
|
|
|
Change from baseline blood glucose at 8 weeks
大体时间:baseline, 8 weeks
|
Used to examine glucose regulation as effected by the apple group intervention.
|
baseline, 8 weeks
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员:Shirin Hooshmand, PhD、San Diego State University
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2014年7月1日
初级完成 (实际的)
2016年2月1日
研究完成 (实际的)
2016年4月1日
研究注册日期
首次提交
2014年8月12日
首先提交符合 QC 标准的
2014年8月13日
首次发布 (估计)
2014年8月15日
研究记录更新
最后更新发布 (实际的)
2017年8月11日
上次提交的符合 QC 标准的更新
2017年8月9日
最后验证
2017年8月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.