Effects Gluten Intake on Body Composition, Energy Expenditure and Adipokine Profile in Non-celiac Women With Obesity
Primary Purpose
Obesity
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
gluten phase
placebo phase
Sponsored by

About this trial
This is an interventional basic science trial for Obesity focused on measuring gluten, adipokine, obesity, diet
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
gluten phase
Placebo phase
Arm Description
volunteers will receive 2 corn muffins containing12g of gluten/muffin to be consumed daily for 4 weeks
volunteers will receive 2 corn muffins without gluten/muffin to be consumed daily for 4 weeks
Outcomes
Primary Outcome Measures
Changes in body Weight
measured in scale presented in kg
Secondary Outcome Measures
Height
measured in meters
Changes in BMI
calculated by body weigh / square of height
Changes in resting metabolic rate
measured by indirect calorimetry in kcal/kg or kcal/day
Changes in macronutrient intake
calculation of food intake based on 24h diary - result in % kcal
waist circumference
measured in cm
Changes in IL-6 blood concentration
measure by ELISA in ug/mL
Changes in IL-10
blood concentration measure by ELISA in ug/mL
Changes in IL-1beta
blood concentration measure by ELISA in ug/mL
Changes in Adiponectin
blood concentration measure by ELISA in ug/mL
Changes in Leptin
blood concentration measure by ELISA in ug/mL
Changes in C reactive protein
blood concentration measure in mg/mL
Full Information
NCT ID
NCT03129932
First Posted
April 21, 2017
Last Updated
July 29, 2020
Sponsor
Jacqueline Isaura Alvarez Leite
Collaborators
Conselho Nacional de Desenvolvimento Científico e Tecnológico, Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
1. Study Identification
Unique Protocol Identification Number
NCT03129932
Brief Title
Effects Gluten Intake on Body Composition, Energy Expenditure and Adipokine Profile in Non-celiac Women With Obesity
Official Title
Effects Gluten on Body Composition, Energy Expenditure and Adipokine Profile in Non-celiac Women With Obesity
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
January 10, 2015 (Actual)
Primary Completion Date
September 1, 2019 (Actual)
Study Completion Date
December 1, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Jacqueline Isaura Alvarez Leite
Collaborators
Conselho Nacional de Desenvolvimento Científico e Tecnológico, Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
gluten, adipokine, obesity, diet
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
double-masked, crossover, randomized, controlled study
Masking
ParticipantInvestigator
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.
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
gluten phase
Arm Type
Active Comparator
Arm Description
volunteers will receive 2 corn muffins containing12g of gluten/muffin to be consumed daily for 4 weeks
Arm Title
Placebo phase
Arm Type
Placebo Comparator
Arm Description
volunteers will receive 2 corn muffins without gluten/muffin to be consumed daily for 4 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
gluten phase
Intervention Description
2 cakes containing 9g of vital gluten/each will be consume during the 4 weeks of intervention
Intervention Type
Dietary Supplement
Intervention Name(s)
placebo phase
Intervention Description
2 cakes without gluten will be consume during the 4 weeks of intervention
Primary Outcome Measure Information:
Title
Changes in body Weight
Description
measured in scale presented in kg
Time Frame
1st, 4th and 8th weeks
Secondary Outcome Measure Information:
Title
Height
Description
measured in meters
Time Frame
1st week
Title
Changes in BMI
Description
calculated by body weigh / square of height
Time Frame
1st, 4th and 8th weeks
Title
Changes in resting metabolic rate
Description
measured by indirect calorimetry in kcal/kg or kcal/day
Time Frame
1st, 4th and 8th weeks
Title
Changes in macronutrient intake
Description
calculation of food intake based on 24h diary - result in % kcal
Time Frame
1st, 4th and 8th weeks
Title
waist circumference
Description
measured in cm
Time Frame
1st, 4th and 8th weeks
Title
Changes in IL-6 blood concentration
Description
measure by ELISA in ug/mL
Time Frame
1st, 4th and 8th weeks
Title
Changes in IL-10
Description
blood concentration measure by ELISA in ug/mL
Time Frame
1st, 4th and 8th weeks
Title
Changes in IL-1beta
Description
blood concentration measure by ELISA in ug/mL
Time Frame
1st, 4th and 8th weeks4th and 8th weeks
Title
Changes in Adiponectin
Description
blood concentration measure by ELISA in ug/mL
Time Frame
1st, 4th and 8th weeks
Title
Changes in Leptin
Description
blood concentration measure by ELISA in ug/mL
Time Frame
1st, 4th and 8th weeks
Title
Changes in C reactive protein
Description
blood concentration measure in mg/mL
Time Frame
1st, 4th and 8th weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
JAQUELINE I ALVAREZ-LEITE, MD, PhD
Organizational Affiliation
Federal University of Minas Gerais
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effects Gluten Intake on Body Composition, Energy Expenditure and Adipokine Profile in Non-celiac Women With Obesity
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