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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
Jacqueline Isaura Alvarez Leite
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Obesity focused on measuring gluten, adipokine, obesity, diet

Eligibility Criteria

20 Years - 50 Years (Adult)FemaleDoes not accept healthy volunteers

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

    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.
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    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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