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Effects Gluten Intake on Body Composition, Energy Expenditure and Adipokine Profile in Non-celiac Women With Obesity

NCT03129932 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2020-07-31

No results posted yet for this study

Summary

This is a double-masked, crossover, randomized, controlled study that aims to evaluate, in women with obesity, a possible influence of wheat gluten on food choices, body weight, resting metabolism and circulating inflammation markers and adipokines. The volunteers will be randomized into two groups, half of them will initiate the experiment by taking 2 placebo muffins daily for 4 weeks (Placebo phase) and the remnant volunteers will take 2 corn muffins containing 12g of gluten/each for 4 weeks (Gluten phase). At the 1st, 4th and 8th experimental weeks will be evaluated body weight, body composition, lipid profile, glucose, insulin, leptin, adiponectin, and inflammatory markers.

Conditions

Interventions

DIETARY_SUPPLEMENT

gluten phase

2 cakes containing 9g of vital gluten/each will be consume during the 4 weeks of intervention

DIETARY_SUPPLEMENT

placebo phase

2 cakes without gluten will be consume during the 4 weeks of intervention

Sponsors & Collaborators

  • Conselho Nacional de Desenvolvimento Científico e Tecnológico

    collaborator OTHER_GOV

  • Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.

    collaborator OTHER_GOV

  • Jacqueline Isaura Alvarez Leite

    lead OTHER

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
20 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-01-10
Primary Completion
2019-09-01
Completion
2019-12-01

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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 NCT03129932 on ClinicalTrials.gov