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| Name | Class |
|---|---|
| Conselho Nacional de Desenvolvimento CientÃfico e Tecnológico | OTHER_GOV |
| Coordenação de Aperfeiçoamento de Pessoal de NÃvel Superior. | OTHER_GOV |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| gluten phase | Active Comparator | volunteers will receive 2 corn muffins containing12g of gluten/muffin to be consumed daily for 4 weeks |
|
| Placebo phase | Placebo Comparator | volunteers will receive 2 corn muffins without gluten/muffin to be consumed daily for 4 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| gluten phase | Dietary Supplement | 2 cakes containing 9g of vital gluten/each will be consume during the 4 weeks of intervention |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes in body Weight | measured in scale presented in kg | 1st, 4th and 8th weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Height | measured in meters | 1st week |
| Changes in BMI | calculated by body weigh / square of height | 1st, 4th and 8th weeks |
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Inclusion Criteria:
Exclusion Criteria:
- Subjects with positive serology for celiac disease or allergy to wheat
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| Name | Affiliation | Role |
|---|---|---|
| JAQUELINE I ALVAREZ-LEITE, MD, PhD | Federal University of Minas Gerais | Principal Investigator |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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double-masked, crossover, randomized, controlled study
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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.
| placebo phase | Dietary Supplement | 2 cakes without gluten will be consume during the 4 weeks of intervention |
|
| Changes in resting metabolic rate | measured by indirect calorimetry in kcal/kg or kcal/day | 1st, 4th and 8th weeks |
| Changes in macronutrient intake | calculation of food intake based on 24h diary - result in % kcal | 1st, 4th and 8th weeks |
| waist circumference | measured in cm | 1st, 4th and 8th weeks |
| Changes in IL-6 blood concentration | measure by ELISA in ug/mL | 1st, 4th and 8th weeks |
| Changes in IL-10 | blood concentration measure by ELISA in ug/mL | 1st, 4th and 8th weeks |
| Changes in IL-1beta | blood concentration measure by ELISA in ug/mL | 1st, 4th and 8th weeks4th and 8th weeks |
| Changes in Adiponectin | blood concentration measure by ELISA in ug/mL | 1st, 4th and 8th weeks |
| Changes in Leptin | blood concentration measure by ELISA in ug/mL | 1st, 4th and 8th weeks |
| Changes in C reactive protein | blood concentration measure in mg/mL | 1st, 4th and 8th weeks |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |