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

NCT03129932 | Completed

• 1 other identifier: 49480215.0.0000.5149
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Obesity

Keywords

gluten; adipokine; obesity; diet

Outcome Measures

Primary Outcomes (1)

• Changes in body Weight

  measured in scale presented in kg

  1st, 4th and 8th weeks

Secondary Outcomes (11)

• Height

  1st week

• Changes in BMI

  1st, 4th and 8th weeks

• Changes in resting metabolic rate

  1st, 4th and 8th weeks

• Changes in macronutrient intake

  1st, 4th and 8th weeks

• waist circumference

  1st, 4th and 8th weeks

Study Arms (2)

gluten phase

ACTIVE COMPARATOR

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

Dietary Supplement: gluten phase

Placebo phase

PLACEBO COMPARATOR

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

Dietary Supplement: placebo phase

Interventions

gluten phase DIETARY_SUPPLEMENT

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

gluten phase

placebo phase DIETARY_SUPPLEMENT

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

Placebo phase

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Jacqueline Isaura Alvarez Leite: lead
• Conselho Nacional de Desenvolvimento Científico e Tecnológico: collaborator
• Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.: collaborator

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• JAQUELINE I ALVAREZ-LEITE, MD, PhD

  Federal University of Minas Gerais

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: volunteers will receive 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.
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD.Ph.D; Full Professor

Model Details: double-masked, crossover, randomized, controlled study

Study Record Dates

• First Submitted: April 21, 2017
• First Posted: April 26, 2017
• Study Start: January 10, 2015
• Primary Completion: September 1, 2019
• Study Completion: December 1, 2019
• Last Updated: July 31, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share