此页面是自动翻译的,不保证翻译的准确性。请参阅 英文版 对于源文本。

Effect of Gluten-free Diets on Anthropometric and Dietary Data of Healthy Eutrophic Women

2017年4月25日 更新者:Jacqueline Isaura Alvarez Leite、Federal University of Minas Gerais
The objective is to evaluate, in healthy, eutrophic women, if gluten intake influences on body weight, basal metabolic rate and macronutrient intake. In a crossover double masked model, 30 volunteers will be randomized into two groups, half of them will initiate the experiment by taking 2 "placebo" muffins daily for 3 weeks (Placebo phase) and the remnant volunteers will take 2 "gluten" muffins for 3 weeks (Gluten phase). After one day of wash out, the volunteers will be transferred for the other phase to complete 3 more experimental weeks.

研究概览

地位

完全的

条件

详细说明

The objective is to evaluate in eutrophic women the impact of intake of moderate amounts of wheat gluten on body weight basal metabolic rate and possible relation to macronutrient intake. For this, 30 volunteers will kept on a restricted diet in gluten-free foods of 6 weeks. At the first moment, a structured Food Frequency Questionnaire will be applied, as well as a 24-hour food register, to evaluate the average food and gluten daily intake. The volunteers will be randomized into two groups, half of them will initiate the experiment by taking 2 placebo muffins daily for 3 weeks (Placebo phase) and the remnant volunteers will take 2 gluten muffins for 3 weeks (Gluten phase). After one day of wash out, the volunteers will be transferred for the other phase to complete 3 more experimental weeks. During these 6 experimental weeks, all volunteers will be instructed to exclude any food containing gluten from their diet. The test food (gluten and placebo muffins) will be produced in the Laboratory of Dietetic Technique of the School of Nursing of the Federal University of Minas Gerais and delivered weekly to each volunteer. Placebo test foods is a corn-based muffin of about 45g. In the Gluten muffins, 10g of corn is replaced by 10g of gluten (corresponding to 7.5g of gluten protein). Each volunteer will be instructed to take 2 (placebo or gluten) muffin/day. To evaluate diet adherence and signs and symptoms of intolerances, volunteers will fill a questionnaire weekly, informing about the consumption of the test food, eventual intake of food containing gluten, and the presence of gastrointestinal signs and symptoms such as constipation, diarrhea, nausea or vomiting etc.

研究类型

介入性

注册 (实际的)

30

阶段

  • 不适用

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

18年 至 40年 (成人)

接受健康志愿者

是的

有资格学习的性别

女性

描述

Inclusion Criteria:

  • Women aged between 18 and 40
  • Body Mass Index (BMI) between 18.5 and 24.9 kg / m²
  • Sign of informed consent
  • Absence of associated chronic diseases

Exclusion Criteria:

  • Postmenopausal patients
  • Onset of chronic medication
  • discontinuance of test food intake for 2or more days
  • Do not attend 2 of the 3 meetings.

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:交叉作业
  • 屏蔽:双倍的

武器和干预

参与者组/臂
干预/治疗
有源比较器:Gluten test food
volunteers will receive 2 corn based muffins containing 7,5g of gluten/muffin to be consumed daily for 3 weeks
Dietary supplement: corn muffins with 7.5g of gluten/muffin Two muffin were blindly administered for 21 days
安慰剂比较:Placebo test food
volunteers will receive 2 corn based muffins to be consumed daily in any meal for 3 weeks
Dietary supplement: corn muffins with 7.5g of gluten/muffin Two muffin were blindly administered for 21 days

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
Changes in body Weight
大体时间:1st, 3rd and 6th weeks
measured in scale presented in kg
1st, 3rd and 6th weeks

次要结果测量

结果测量
措施说明
大体时间
高度
大体时间:第一周
以米为单位
第一周
Changes in resting metabolic rate
大体时间:1st, 3rd and 6th weeks
measured by indirect calorimetry in kcal/kg or kcal/day
1st, 3rd and 6th weeks
Changes in macronutrient intake
大体时间:1st, 3rd and 6th weeks
calculation of food intake based on 24h diary - result in % kcal
1st, 3rd and 6th weeks
waist circumference
大体时间:1st, 3rd and 6th weeks
measured in cm
1st, 3rd and 6th weeks
BMI
大体时间:1st, 3rd and 6th weeks
calculated by body weigh / square of height
1st, 3rd and 6th 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:JAQUELINE I ALVAREZ-LEITE、Federal University of Minas Gerais

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 (实际的)

2016年3月3日

初级完成 (实际的)

2016年12月2日

研究完成 (实际的)

2017年3月3日

研究注册日期

首次提交

2017年4月21日

首先提交符合 QC 标准的

2017年4月21日

首次发布 (实际的)

2017年4月26日

研究记录更新

最后更新发布 (实际的)

2017年4月27日

上次提交的符合 QC 标准的更新

2017年4月25日

最后验证

2017年4月1日

更多信息

与本研究相关的术语

其他研究编号

  • 49480215000005149H

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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.

订阅