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

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

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.

Study Overview

• Status: Completed
• Conditions: Obesity
• Intervention / Treatment: Dietary supplement: gluten phase; Dietary supplement: placebo phase

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.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: gluten phase; volunteers will receive 2 corn muffins containing12g of gluten/muffin to be consumed daily for 4 weeks	Dietary supplement: gluten phase; 2 cakes containing 9g of vital gluten/each will be consume during the 4 weeks of intervention
Placebo Comparator: Placebo phase; volunteers will receive 2 corn muffins without gluten/muffin to be consumed daily for 4 weeks	Dietary supplement: placebo phase; 2 cakes without gluten will be consume during the 4 weeks of intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in body Weight	measured in scale presented in kg	1st, 4th and 8th weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Height	measured in meters	1st week
Changes in BMI	calculated by body weigh / square of height	1st, 4th and 8th weeks
Changes in resting metabolic rate	measured by indirect calorimetry in kcal/kg or kcal/day	1st, 4th and 8th weeks
Changes in macronutrient intake	calculation of food intake based on 24h diary - result in % kcal	1st, 4th and 8th weeks
waist circumference	measured in cm	1st, 4th and 8th weeks
Changes in IL-6 blood concentration	measure by ELISA in ug/mL	1st, 4th and 8th weeks
Changes in IL-10	blood concentration measure by ELISA in ug/mL	1st, 4th and 8th weeks
Changes in IL-1beta	blood concentration measure by ELISA in ug/mL	1st, 4th and 8th weeks4th and 8th weeks
Changes in Adiponectin	blood concentration measure by ELISA in ug/mL	1st, 4th and 8th weeks
Changes in Leptin	blood concentration measure by ELISA in ug/mL	1st, 4th and 8th weeks
Changes in C reactive protein	blood concentration measure in mg/mL	1st, 4th and 8th weeks

Collaborators and Investigators

• Sponsor: Jacqueline Isaura Alvarez Leite
• Collaborators: Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.; Conselho Nacional de Desenvolvimento Científico e Tecnológico
• Investigators: Principal Investigator: JAQUELINE I ALVAREZ-LEITE, MD, PhD, Federal University of Minas Gerais

Study record dates

Study Major Dates

• Study Start (Actual): January 10, 2015
• Primary Completion (Actual): September 1, 2019
• Study Completion (Actual): December 1, 2019

Study Registration Dates

• First Submitted: April 21, 2017
• First Submitted That Met QC Criteria: April 21, 2017
• First Posted (Actual): April 26, 2017

Study Record Updates

• Last Update Posted (Actual): July 31, 2020
• Last Update Submitted That Met QC Criteria: July 29, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: obesity; diet; gluten; adipokine
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity
• Other Study ID Numbers: 49480215.0.0000.5149

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No