Effect of Gluten-free Diets on Anthropometric and Dietary Data of Healthy Eutrophic Women
- Conditions
- Obesity
- Interventions
- Dietary Supplement: Gluten test food
- Registration Number
- NCT03129997
- Lead Sponsor
- Federal University of Minas Gerais
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 30
- 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
- Postmenopausal patients
- Onset of chronic medication
- discontinuance of test food intake for 2or more days
- Do not attend 2 of the 3 meetings.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Placebo test food Gluten test food volunteers will receive 2 corn based muffins to be consumed daily in any meal for 3 weeks Gluten test food Gluten test food volunteers will receive 2 corn based muffins containing 7,5g of gluten/muffin to be consumed daily for 3 weeks
- Primary Outcome Measures
Name Time Method Changes in body Weight 1st, 3rd and 6th weeks measured in scale presented in kg
- Secondary Outcome Measures
Name Time Method Changes in resting metabolic rate 1st, 3rd and 6th weeks measured by indirect calorimetry in kcal/kg or kcal/day
waist circumference 1st, 3rd and 6th weeks measured in cm
Changes in macronutrient intake 1st, 3rd and 6th weeks calculation of food intake based on 24h diary - result in % kcal
BMI 1st, 3rd and 6th weeks calculated by body weigh / square of height
Height 1st week measured in meters