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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Obesity

Intervention / Treatment
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* Dietary Supplement: Gluten test food


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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: crossover double masked model
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Gluten test food<br>volunteers will receive 2 corn based muffins containing 7,5g of gluten/muffin to be consumed daily for 3 weeks | Dietary Supplement: Gluten test food<br>* Dietary supplement: corn muffins with 7.5g of gluten/muffin Two muffin were blindly administered for 21 days<br>|
| Placebo Comparator: Placebo test food<br>volunteers will receive 2 corn based muffins to be consumed daily in any meal for 3 weeks | Dietary Supplement: Gluten test food<br>* Dietary supplement: corn muffins with 7.5g of gluten/muffin Two muffin were blindly administered for 21 days<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, 3rd and 6th weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in resting metabolic rate | measured by indirect calorimetry in kcal/kg or kcal/day | 1st, 3rd and 6th weeks | 
| Changes in macronutrient intake | calculation of food intake based on 24h diary - result in % kcal | 1st, 3rd and 6th weeks | 
| waist circumference | measured in cm | 1st, 3rd and 6th weeks | 
| Height | measured in meters | 1st week | 
| BMI | calculated by body weigh / square of height | 1st, 3rd and 6th weeks |