Clinical trial NCT03129932: 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
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: gluten
adipokine
obesity
diet
Lead sponsor: Federal University of Minas Gerais
Sponsor class: OTHER
Collaborators: name: Conselho Nacional de Desenvolvimento Científico e Tecnológico
name: Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
First posted: 2017-04-26
Enrollment: 40
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: double-masked, crossover, randomized, controlled study
Primary purpose: BASIC_SCIENCE

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.

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

Primary outcomes:
measure: Changes in body Weight
timeFrame: 1st, 4th and 8th weeks
Secondary outcomes:
measure: Height
timeFrame: 1st week
measure: Changes in BMI
timeFrame: 1st, 4th and 8th weeks
measure: Changes in resting metabolic rate
timeFrame: 1st, 4th and 8th weeks
measure: Changes in macronutrient intake
timeFrame: 1st, 4th and 8th weeks
measure: waist circumference
timeFrame: 1st, 4th and 8th weeks
measure: Changes in IL-6 blood concentration
timeFrame: 1st, 4th and 8th weeks
measure: Changes in IL-10
timeFrame: 1st, 4th and 8th weeks
measure: Changes in IL-1beta
timeFrame: 1st, 4th and 8th weeks4th and 8th weeks
measure: Changes in Adiponectin
timeFrame: 1st, 4th and 8th weeks
measure: Changes in Leptin
timeFrame: 1st, 4th and 8th weeks
measure: Changes in C reactive protein
timeFrame: 1st, 4th and 8th weeks
Other outcomes:
Locations:
Study officials:
affiliation: Federal University of Minas Gerais
name: JAQUELINE I ALVAREZ-LEITE, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: