Feeding Behavior Clinical Trial
Official title:
Clinical Study Randomized of the Effects of the Administered Time of Meal on the Treatment of Overweight and Obesity
Objectives: To evaluate the impact of the meal time administered on the body weight of adult
individuals of both sexes, being overweight and obese.
Experimental design: randomized controlled trial. Place of research: Hospital de Clínicas de
Porto Alegre, Porto Alegre, RS, Brazil.
Materials and methods: Anthropometric data, blood pressure, waist diameter will be measured;
venous blood samples will be collected and stored for glucose, total cholesterol,
triglycerides, HDL-cholesterol, urea, creatinine and ALT in serum.
Intervention: Wait at least 20 minutes after finishing the first portion of meals, previously
considered sufficient by the individual before serving again. The control group will also
serve the dish the same way, but you can serve additional portion without waiting.
Measurements: P values less than 0.05 will be considered statistically significant.
Expected results: Weight loss, decrease in anthropometric markers and risk factors for
cardiovascular diseases.
Status | Recruiting |
Enrollment | 110 |
Est. completion date | July 2018 |
Est. primary completion date | December 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 20 Years to 59 Years |
Eligibility |
Inclusion Criteria: - Overweight and obesity grade I, according to WHO criteria (1998). Exclusion Criteria: - Normal weight, obesity> grade I; - Use of appetite-enhancing medications such as glucocorticoids, tricyclic antidepressants, antipsychotics, mood modulators and anticonvulsants, or reduce body weight , such as anorexigenics, and antidiabetics that can modify body weight; - In follow-up or nutritional intervention already established and; - Refusal to sign the informed consent form. |
Country | Name | City | State |
---|---|---|---|
Brazil | Hospital de Clínicas de Porto Alegre | Porto Alegre | Rio Grande Do Sul |
Lead Sponsor | Collaborator |
---|---|
Hospital de Clinicas de Porto Alegre |
Brazil,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Mean body weight | Measurement of body weight in kilograms - will be carried out on the balance of Toledo® brand with a capacity of 200 kg, after urinating. The individual will keep his body erect, with arms hanging over the body and heels attached. Participants should only be in their underwear and disposable surgical dress, barefoot. |
30 days | |
Secondary | Cardiovascular risk assessment scores | The calculation will be done with the CV Risk Calculator tool of the American College of Cardiology and the American Cardiology Association to obtain the percentage (%) risk for acute myocardial infarction or stroke in ten years. | 30 days | |
Secondary | Waist diameter values | It will be obtained with flexible tape and inelastic (in centimeters), with the individual standing erect, arms extended along the body and feet together. The tape will be positioned at the midpoint between the iliac crest and the outer side of the last rib. |
30 days |
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