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NCT Number: NCT03129932

Effects Gluten Intake 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.

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Key information

Age range

20 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

gluten phase

Dietary Supplement

2 cakes containing 9g of vital gluten/each will be consume during the 4 weeks of intervention

placebo phase

Dietary Supplement

2 cakes without gluten will be consume during the 4 weeks of intervention

Primary outcomes

  1. Changes in body Weight

    Time frame: 1st, 4th and 8th weeks

    measured in scale presented in kg

Secondary outcomes

  1. Height

    Time frame: 1st week

    measured in meters

  2. Changes in BMI

    Time frame: 1st, 4th and 8th weeks

    calculated by body weigh / square of height

  3. Changes in resting metabolic rate

    Time frame: 1st, 4th and 8th weeks

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

  4. Changes in macronutrient intake

    Time frame: 1st, 4th and 8th weeks

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

  5. waist circumference

    Time frame: 1st, 4th and 8th weeks

    measured in cm

  6. Changes in IL-6 blood concentration

    Time frame: 1st, 4th and 8th weeks

    measure by ELISA in ug/mL

  7. Changes in IL-10

    Time frame: 1st, 4th and 8th weeks

    blood concentration measure by ELISA in ug/mL

  8. Changes in IL-1beta

    Time frame: 1st, 4th and 8th weeks4th and 8th weeks

    blood concentration measure by ELISA in ug/mL

  9. Changes in Adiponectin

    Time frame: 1st, 4th and 8th weeks

    blood concentration measure by ELISA in ug/mL

  10. Changes in Leptin

    Time frame: 1st, 4th and 8th weeks

    blood concentration measure by ELISA in ug/mL

  11. Changes in C reactive protein

    Time frame: 1st, 4th and 8th weeks

    blood concentration measure in mg/mL

Sponsors and collaborators

Lead sponsor

Jacqueline Isaura Alvarez Leite

Other

Collaborators

  • Conselho Nacional de Desenvolvimento Científico e Tecnológico
  • Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Apr 26, 2017
Registry last updated
Jul 31, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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