Clinical trial NCT03129997: Effect of Gluten-free Diets on Anthropometric and Dietary Data of Healthy Eutrophic Women
Official title: Effect of Gluten-free Diets on Anthropometric and Dietary Data of Healthy Eutrophic Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Lead sponsor: Federal University of Minas Gerais
Sponsor class: OTHER
Collaborators: name: Conselho Nacional de Desenvolvimento Científico e Tecnológico
name: Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
First posted: 2017-04-26
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: crossover double masked model
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Changes in body Weight
timeFrame: 1st, 3rd and 6th weeks
Secondary outcomes:
measure: Changes in resting metabolic rate
timeFrame: 1st, 3rd and 6th weeks
measure: Changes in macronutrient intake
timeFrame: 1st, 3rd and 6th weeks
measure: waist circumference
timeFrame: 1st, 3rd and 6th weeks
measure: Height
timeFrame: 1st week
measure: BMI
timeFrame: 1st, 3rd and 6th weeks
Other outcomes:
Locations:
Study officials:
affiliation: Federal University of Minas Gerais
name: JAQUELINE I ALVAREZ-LEITE
role: PRINCIPAL_INVESTIGATOR
References: