gluten phase
Dietary Supplement2 cakes containing 9g of vital gluten/each will be consume during the 4 weeks of intervention
NCT Number: NCT03129932
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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Notify Me20 year–50 year
Female
Interventional
Not applicable
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
2 cakes containing 9g of vital gluten/each will be consume during the 4 weeks of intervention
2 cakes without gluten will be consume during the 4 weeks of intervention
Time frame: 1st, 4th and 8th weeks
measured in scale presented in kg
Time frame: 1st week
measured in meters
Time frame: 1st, 4th and 8th weeks
calculated by body weigh / square of height
Time frame: 1st, 4th and 8th weeks
measured by indirect calorimetry in kcal/kg or kcal/day
Time frame: 1st, 4th and 8th weeks
calculation of food intake based on 24h diary - result in % kcal
Time frame: 1st, 4th and 8th weeks
measured in cm
Time frame: 1st, 4th and 8th weeks
measure by ELISA in ug/mL
Time frame: 1st, 4th and 8th weeks
blood concentration measure by ELISA in ug/mL
Time frame: 1st, 4th and 8th weeks4th and 8th weeks
blood concentration measure by ELISA in ug/mL
Time frame: 1st, 4th and 8th weeks
blood concentration measure by ELISA in ug/mL
Time frame: 1st, 4th and 8th weeks
blood concentration measure by ELISA in ug/mL
Time frame: 1st, 4th and 8th weeks
blood concentration measure in mg/mL
Jacqueline Isaura Alvarez Leite
Other
Effects Gluten on Body Composition, Energy Expenditure and Adipokine Profile in Non-celiac Women With Obesity
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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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