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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Obesity

Intervention / Treatment
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* Dietary Supplement: gluten phase
* Dietary Supplement: placebo phase


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women between 20 and 50 years without diagnosis of celiac disease overweight and obese, respectively, BMI of 24.9- 34.9 without menopause Exclusion Criteria: - Subjects with positive serology for celiac disease or allergy to wheat

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: double-masked, crossover, randomized, controlled study
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: gluten phase<br>volunteers will receive 2 corn muffins containing12g of gluten/muffin to be consumed daily for 4 weeks | Dietary Supplement: gluten phase<br>* 2 cakes containing 9g of vital gluten/each will be consume during the 4 weeks of intervention<br>|
| Placebo Comparator: Placebo phase<br>volunteers will receive 2 corn muffins without gluten/muffin to be consumed daily for 4 weeks | Dietary Supplement: placebo phase<br>* 2 cakes without gluten will be consume during the 4 weeks of intervention<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in body Weight | measured in scale presented in kg | 1st, 4th and 8th weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Height | measured in meters | 1st week | 
| Changes in BMI | calculated by body weigh / square of height | 1st, 4th and 8th weeks | 
| Changes in resting metabolic rate | measured by indirect calorimetry in kcal/kg or kcal/day | 1st, 4th and 8th weeks | 
| Changes in macronutrient intake | calculation of food intake based on 24h diary - result in % kcal | 1st, 4th and 8th weeks | 
| waist circumference | measured in cm | 1st, 4th and 8th weeks | 
| Changes in IL-6 blood concentration | measure by ELISA in ug/mL | 1st, 4th and 8th weeks | 
| Changes in IL-10 | blood concentration measure by ELISA in ug/mL | 1st, 4th and 8th weeks | 
| Changes in IL-1beta | blood concentration measure by ELISA in ug/mL | 1st, 4th and 8th weeks4th and 8th weeks | 
| Changes in Adiponectin | blood concentration measure by ELISA in ug/mL | 1st, 4th and 8th weeks | 
| Changes in Leptin | blood concentration measure by ELISA in ug/mL | 1st, 4th and 8th weeks | 
| Changes in C reactive protein | blood concentration measure in mg/mL | 1st, 4th and 8th weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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gluten, adipokine, obesity, diet