Effects Gluten on Body Composition, Energy Expenditure and Adipokine Profile in Non-celiac Women With Obesity
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
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
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
Jacqueline Isaura Alvarez Leite
MD.Ph.D; Full Professor
Federal University of Minas Gerais
