Obesity
Conditions
Keywords
gluten, adipokine, obesity, diet
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.
Interventions
DIETARY_SUPPLEMENTgluten phase
2 cakes containing 9g of vital gluten/each will be consume during the 4 weeks of intervention
DIETARY_SUPPLEMENTplacebo phase
2 cakes without gluten will be consume during the 4 weeks of intervention
Sponsors
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
Jacqueline Isaura Alvarez Leite
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, 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.
Intervention model description
double-masked, crossover, randomized, controlled study
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 50 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in body Weight | 1st, 4th and 8th weeks | measured in scale presented in kg |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in BMI | 1st, 4th and 8th weeks | calculated by body weigh / square of height |
| Changes in resting metabolic rate | 1st, 4th and 8th weeks | measured by indirect calorimetry in kcal/kg or kcal/day |
| Changes in macronutrient intake | 1st, 4th and 8th weeks | calculation of food intake based on 24h diary - result in % kcal |
| waist circumference | 1st, 4th and 8th weeks | measured in cm |
| Changes in IL-6 blood concentration | 1st, 4th and 8th weeks | measure by ELISA in ug/mL |
| Height | 1st week | measured in meters |
| Changes in IL-1beta | 1st, 4th and 8th weeks4th and 8th weeks | blood concentration measure by ELISA in ug/mL |
| Changes in Adiponectin | 1st, 4th and 8th weeks | blood concentration measure by ELISA in ug/mL |
| Changes in Leptin | 1st, 4th and 8th weeks | blood concentration measure by ELISA in ug/mL |
| Changes in C reactive protein | 1st, 4th and 8th weeks | blood concentration measure in mg/mL |
| Changes in IL-10 | 1st, 4th and 8th weeks | blood concentration measure by ELISA in ug/mL |
Outcome results
None listed