Bread in Overweight/Obesity Treatment

Study Overview
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Brief Summary
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The purpose of this study is to determine the utility of an hypocaloric diet with or without bread in patients with overweight and obesity

Official Title
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Evaluation of the Utility of an Hypocaloric Diet With or Without Bread in Overweight/Obesity Treatment

Conditions
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Overweight, Obesity

Intervention / Treatment
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* Other: hypocaloric diet balanced + nutrition education + ruled physical activity


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age > 18 years sex female signed informed consent patient with overweight and obesity (IMC: > 25 < 39.9) Exclusion Criteria: Family and social environment that prevents compliance with treatment diet. Having to perform any kind of diet special sickness associated: Celiac disease, chronic renal failure, etc. patients with Diabetes Mellitus. patients with Eating disorders. patients with Dementia, Mental illness or impaired function cognitive. consuming drugs or substances for losing weight (except in those cases in which suspension thereof 15 days of beginning the study). Present disease which may interfere with weight loss: serious psychiatric disease, hypothyroidism not controlled. Be pregnant or period of lactation. Inability to comply with the physical activity plan agreed. Want to quit smoking during the time that lasts for the study.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: group bread<br>group who received an hypocaloric balanced diet including bread | Other: hypocaloric diet balanced + nutrition education + ruled physical activity<br> <br> |
| Active Comparator: group without bread<br>group who received a hypocaloric balanced diet with exclusion of bread | Other: hypocaloric diet balanced + nutrition education + ruled physical activity<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| changes in anthropometric parameters | weight, height, BMI, fat mass, lean mass. | after 16 weeks of start the diet | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| changes in biochemical parameters | hematocrit, hemoglobin, lipid profile, ghrelin, leptin, adiponectin. | after 16 weeks of start the diet | 
| Adherence | Validated scale | after 16 weeks of start the diet | 
| change in satiety and hunger Test | visual analogue scale | after 16 weeks of start the diet | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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overweight, obesity, bread, hypocaloric diet