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临床试验/NCT03129932
NCT03129932已完成不适用

Effects Gluten on Body Composition, Energy Expenditure and Adipokine Profile in Non-celiac Women With Obesity

Jacqueline Isaura Alvarez Leite0 个研究点目标入组 40 人开始时间: 2015年1月10日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
40
主要终点
Changes in body Weight

研究概览

简要总结

This is a double-masked, crossover, randomized, controlled study that aims to evaluate, in women with obesity, a possible influence of wheat gluten on food choices, body weight, resting metabolism and circulating inflammation markers and adipokines. The volunteers will be randomized into two groups, half of them will initiate the experiment by taking 2 placebo muffins daily for 4 weeks (Placebo phase) and the remnant volunteers will take 2 corn muffins containing 12g of gluten/each for 4 weeks (Gluten phase). At the 1st, 4th and 8th experimental weeks will be evaluated body weight, body composition, lipid profile, glucose, insulin, leptin, adiponectin, and inflammatory markers.

详细描述

It is a double-masked, crossover, randomized, controlled study. For this, volunteers will be kept on gluten-free diet for 8 weeks. At the first moment, a structured Food Frequency Questionnaire will be applied, as well as a 72-hour food register, to evaluate routine of food consumption and daily intake of gluten. The volunteers will be randomized into two groups, half of them will initiate the experiment by taking 2 placebo muffins daily for 4 weeks (Placebo phase) and the remnant volunteers will take 2 corn muffins containing 12g of gluten/each for 4 weeks (Gluten phase). After that, volunteers will be transferred for the other phase for 4 more weeks. During the 8 experimental weeks, all volunteers will be instructed to exclude any food containing gluten from their diet. At the 1st, 4th and 8th experimental weeks after 12 hours of fasting and 30 minutes of resting, volunteers will be submitted to indirect calorimetry, electrical bioimpedance, blood collection and anthropometry (weight and height). The volunteers will also respond a questionnaire about life habits, family history, previous history, physical activity and food frequency. Blood samples will be used to assess blood count, lipid profile, glucose, insulin, leptin, adiponectin, and inflammatory markers (soluble VCAM, C-reactive protein, fibrinogen). Four weeks after the end of the experiment, and return to the alimentary routine, body weight, blood sample, calorimetry and bioimpedance will be reassessed.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Basic Science
盲法
Double (Participant, Investigator)

盲法说明

volunteers will receive placebo or gluten corn muffins that are similar in taste and appearance. Investigator does not know who is receiving placebo or gluten muffins. During analyses, each sample is coded to avoid volunteer or phase identification.

入排标准

年龄范围
20 Years 至 50 Years(Adult)
性别
Female
接受健康志愿者
否

入选标准

  • •Women between 20 and 50 years without diagnosis of celiac disease
  • •overweight and obese, respectively, BMI of 24.9- 34.9
  • •without menopause

排除标准

  • •Subjects with positive serology for celiac disease or allergy to wheat

研究组 & 干预措施

gluten phase

Active Comparator

volunteers will receive 2 corn muffins containing12g of gluten/muffin to be consumed daily for 4 weeks

干预措施: gluten phase (Dietary Supplement)

Placebo phase

Placebo Comparator

volunteers will receive 2 corn muffins without gluten/muffin to be consumed daily for 4 weeks

干预措施: placebo phase (Dietary Supplement)

结局指标

主要结局

Changes in body Weight

时间窗: 1st, 4th and 8th weeks

measured in scale presented in kg

次要结局

  • Height(1st week)
  • Changes in BMI(1st, 4th and 8th weeks)
  • Changes in resting metabolic rate(1st, 4th and 8th weeks)
  • Changes in macronutrient intake(1st, 4th and 8th weeks)
  • waist circumference(1st, 4th and 8th weeks)
  • Changes in IL-6 blood concentration(1st, 4th and 8th weeks)
  • Changes in IL-10(1st, 4th and 8th weeks)
  • Changes in IL-1beta(1st, 4th and 8th weeks4th and 8th weeks)
  • Changes in Adiponectin(1st, 4th and 8th weeks)
  • Changes in Leptin(1st, 4th and 8th weeks)
  • Changes in C reactive protein(1st, 4th and 8th weeks)

研究者

发起方
Jacqueline Isaura Alvarez Leite
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Jacqueline Isaura Alvarez Leite

MD.Ph.D; Full Professor

Federal University of Minas Gerais

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