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

NCT03129997 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2017-04-27

No results posted yet for this study

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.

Conditions

Interventions

DIETARY_SUPPLEMENT

Gluten test food

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

Sponsors & Collaborators

  • Conselho Nacional de Desenvolvimento Científico e Tecnológico

    collaborator OTHER_GOV

  • Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.

    collaborator OTHER_GOV

  • Federal University of Minas Gerais

    lead OTHER

Principal Investigators

  • JAQUELINE I ALVAREZ-LEITE · Federal University of Minas Gerais

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-03-03
Primary Completion
2016-12-02
Completion
2017-03-03

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Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03129997 on ClinicalTrials.gov