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Completed

NCT Number: NCT03129997

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

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.

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Key information

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Gluten test food

Dietary Supplement

Dietary supplement: corn muffins with 7.5g of gluten/muffin Two muffin were blindly administered for 21 days

Primary outcomes

  1. Changes in body Weight

    Time frame: 1st, 3rd and 6th weeks

    measured in scale presented in kg

Secondary outcomes

  1. Changes in resting metabolic rate

    Time frame: 1st, 3rd and 6th weeks

    measured by indirect calorimetry in kcal/kg or kcal/day

  2. Changes in macronutrient intake

    Time frame: 1st, 3rd and 6th weeks

    calculation of food intake based on 24h diary - result in % kcal

  3. waist circumference

    Time frame: 1st, 3rd and 6th weeks

    measured in cm

  4. Height

    Time frame: 1st week

    measured in meters

  5. BMI

    Time frame: 1st, 3rd and 6th weeks

    calculated by body weigh / square of height

Sponsors and collaborators

Lead sponsor

Federal University of Minas Gerais

Other

Collaborators

  • Conselho Nacional de Desenvolvimento Científico e Tecnológico
  • Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.

Registry information

Important dates

Study start
2016
Primary completion
2016
Study completion
2017
First posted
Apr 26, 2017
Registry last updated
Apr 27, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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