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

NCT ID: NCT03129932

Last Updated: 2020-07-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-10
• Study Completion Date: 2019-12-01

Brief 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.

Detailed Description

It is a double-masked, crossover, randomized, controlled study. For this, volunteers will be kept on gluten-free diet for 8 weeks. At the first moment, a structured Food Frequency Questionnaire will be applied, as well as a 72-hour food register, to evaluate routine of food consumption and daily intake of gluten. 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). After that, volunteers will be transferred for the other phase for 4 more weeks. During the 8 experimental weeks, all volunteers will be instructed to exclude any food containing gluten from their diet. At the 1st, 4th and 8th experimental weeks after 12 hours of fasting and 30 minutes of resting, volunteers will be submitted to indirect calorimetry, electrical bioimpedance, blood collection and anthropometry (weight and height). The volunteers will also respond a questionnaire about life habits, family history, previous history, physical activity and food frequency. Blood samples will be used to assess blood count, lipid profile, glucose, insulin, leptin, adiponectin, and inflammatory markers (soluble VCAM, C-reactive protein, fibrinogen). Four weeks after the end of the experiment, and return to the alimentary routine, body weight, blood sample, calorimetry and bioimpedance will be reassessed.

Conditions

Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

gluten phase

volunteers will receive 2 corn muffins containing12g of gluten/muffin to be consumed daily for 4 weeks

Group Type: ACTIVE_COMPARATOR

gluten phase

Intervention Type: DIETARY_SUPPLEMENT

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

Placebo phase

volunteers will receive 2 corn muffins without gluten/muffin to be consumed daily for 4 weeks

Group Type: PLACEBO_COMPARATOR

placebo phase

Intervention Type: DIETARY_SUPPLEMENT

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

Interventions

gluten phase

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

Intervention Type: DIETARY_SUPPLEMENT

placebo phase

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

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• Women between 20 and 50 years without diagnosis of celiac disease
• overweight and obese, respectively, BMI of 24.9- 34.9
• without menopause

Exclusion Criteria

• Subjects with positive serology for celiac disease or allergy to wheat

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Conselho Nacional de Desenvolvimento Científico e Tecnológico

OTHER_GOV

Sponsor Role: collaborator

Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.

OTHER_GOV

Sponsor Role: collaborator

Jacqueline Isaura Alvarez Leite

OTHER

Sponsor Role: lead

Responsible Party

Jacqueline Isaura Alvarez Leite

MD.Ph.D; Full Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

JAQUELINE I ALVAREZ-LEITE, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Federal University of Minas Gerais

Other Identifiers

49480215.0.0000.5149

Identifier Type: -

Identifier Source: org_study_id