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临床试验/NCT02217124
NCT02217124已完成不适用

Impact of High Fiber Snacks on Adiposity, Glucose Regulation and Appetite in Children

San Diego State University2 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2014年7月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
45
试验地点
2
主要终点
Change from baseline Body Composition at 8 weeks

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
None

入排标准

年龄范围
10 Years 至 16 Years(Child)
性别
All
接受健康志愿者

入选标准

  • must be between age 10-16
  • must be overweight or obese according to growth charts

排除标准

  • regular consumers of apples (one per day)
  • supplement users other than multivitamin

研究组 & 干预措施

Apple group

Experimental

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.

干预措施: dried apples (Other)

Muffin control

Placebo Comparator

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.

干预措施: muffin (Other)

结局指标

主要结局

Change from baseline Body Composition at 8 weeks

时间窗: 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.

次要结局

  • Change from baseline of triglycerides at 8 weeks(baseline, 8 weeks)
  • Change from baseline blood glucose at 8 weeks(baseline, 8 weeks)

研究者

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

Dr. Shirin Hooshmand

Assistant Professor

San Diego State University

研究点 (2)

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