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Clinical Trials/NCT03129997
NCT03129997CompletedNot Applicable

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

Federal University of Minas Gerais0 sites30 target enrollmentStarted: March 3, 2016Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
30
Primary Endpoint
Changes in body Weight

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Basic Science
Masking
Double (Participant, Investigator)

Masking Description

volunteers received placebo or gluten corn muffins that are similar in taste and appearance. Investigator does not know who is receiving placebo or gluten muffins. During analyses, each sample is coded to avoid volunteer or phase identification.

Eligibility Criteria

Ages
18 Years to 40 Years (Adult)
Sex
Female
Accepts Healthy Volunteers
Yes

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.

Outcomes

Primary Outcomes

Changes in body Weight

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

measured in scale presented in kg

Secondary Outcomes

  • Changes in resting metabolic rate(1st, 3rd and 6th weeks)
  • waist circumference(1st, 3rd and 6th weeks)
  • Changes in macronutrient intake(1st, 3rd and 6th weeks)
  • BMI(1st, 3rd and 6th weeks)
  • Height(1st week)

Investigators

Sponsor
Federal University of Minas Gerais
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Jacqueline Isaura Alvarez Leite

MD,Ph.D

Federal University of Minas Gerais

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