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

• Sponsor: Jacqueline Isaura Alvarez Leite (Other)
• Overall Status: Completed
• CT.gov ID: NCT03129932
• Collaborator: Conselho Nacional de Desenvolvimento Científico e Tecnológico (Other), Coordenação de Aperfeiçoamento de Pessoal de Nível Superior. (Other)
• Enrollment: 40
• Arms: 2
• Actual Duration (Months): 58.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Obesity	Dietary Supplement: gluten phase; Dietary Supplement: placebo phase	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Intervention Model Description: double-masked, crossover, randomized, controlled studydouble-masked, crossover, randomized, controlled study
• Masking: Double (Participant, Investigator)
• Masking Description: 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.
• Primary Purpose: Basic Science
• Official Title: Effects Gluten on Body Composition, Energy Expenditure and Adipokine Profile in Non-celiac Women With Obesity
• Actual Study Start Date: Jan 10, 2015
• Actual Primary Completion Date: Sep 1, 2019
• Actual Study Completion Date: Dec 1, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Changes in body Weight [1st, 4th and 8th weeks]

   measured in scale presented in kg

Secondary Outcome Measures

1. Height [1st week]

   measured in meters

2. Changes in BMI [1st, 4th and 8th weeks]

   calculated by body weigh / square of height

3. Changes in resting metabolic rate [1st, 4th and 8th weeks]

   measured by indirect calorimetry in kcal/kg or kcal/day

4. Changes in macronutrient intake [1st, 4th and 8th weeks]

   calculation of food intake based on 24h diary - result in % kcal

5. waist circumference [1st, 4th and 8th weeks]

   measured in cm

6. Changes in IL-6 blood concentration [1st, 4th and 8th weeks]

   measure by ELISA in ug/mL

7. Changes in IL-10 [1st, 4th and 8th weeks]

   blood concentration measure by ELISA in ug/mL

8. Changes in IL-1beta [1st, 4th and 8th weeks4th and 8th weeks]

   blood concentration measure by ELISA in ug/mL

9. Changes in Adiponectin [1st, 4th and 8th weeks]

   blood concentration measure by ELISA in ug/mL

10. Changes in Leptin [1st, 4th and 8th weeks]

    blood concentration measure by ELISA in ug/mL

11. Changes in C reactive protein [1st, 4th and 8th weeks]

    blood concentration measure in mg/mL

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 50 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

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

Investigators

• Principal Investigator: JAQUELINE I ALVAREZ-LEITE, MD, PhD, Federal University of Minas Gerais

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Jacqueline Isaura Alvarez Leite, MD.Ph.D; Full Professor, Federal University of Minas Gerais
• ClinicalTrials.gov Identifier: NCT03129932
• Other Study ID Numbers: 49480215.0.0000.5149
• First Posted: Apr 26, 2017
• Last Update Posted: Jul 31, 2020
• Last Verified: Jul 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Jacqueline Isaura Alvarez Leite, MD.Ph.D; Full Professor, Federal University of Minas Gerais: gluten; adipokine; obesity; diet
• Additional relevant MeSH terms: Obesity

Study Results

No Results Posted as of Jul 31, 2020