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

Not Applicable

Completed

• Conditions: Obesity
• Interventions: Dietary Supplement: gluten phase; Dietary Supplement: placebo phase

• Registration Number: NCT03129932
• Lead Sponsor: Jacqueline Isaura Alvarez Leite

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.

Study Timeline

• Study Start: 2015-01-10
• Study First Submitted: 2017-04-21
• Study First Submitted QC: 2017-04-21
• Study First Posted: 2017-04-26
• Primary Completion: 2019-09-01
• Study Completion: 2019-12-01
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-29
• Last Update Posted: 2020-07-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
gluten phase	gluten phase	volunteers will receive 2 corn muffins containing12g of gluten/muffin to be consumed daily for 4 weeks
Placebo phase	placebo phase	volunteers will receive 2 corn muffins without gluten/muffin to be consumed daily for 4 weeks

Primary Outcome Measures

Name	Time	Method
Changes in body Weight	1st, 4th and 8th weeks	measured in scale presented in kg

Secondary Outcome Measures

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