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

Federal University of Minas Gerais

Status: Completed

Conditions: Obesity

Treatments: Dietary Supplement: Gluten test food

Study type: Interventional

Funder types: Other

Identifiers

NCT03129997

49480215000005149H

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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30 participants in 2 patient groups, including a placebo group

Gluten test food

Active Comparator group

Description:

volunteers will receive 2 corn based muffins containing 7,5g of gluten/muffin to be consumed daily for 3 weeks

Treatment:

Dietary Supplement: Gluten test food

Placebo test food

Placebo Comparator group

Description:

volunteers will receive 2 corn based muffins to be consumed daily in any meal for 3 weeks

Treatment:

Dietary Supplement: Gluten test food