NCT01223989CompletedPhase 4
Evaluation of the Utility of an Hypocaloric Diet With or Without Bread in Overweight/Obesity Treatment
Fundacion para la Investigacion Biomedica del Hospital Universitario la Paz0 sites122 target enrollmentStarted: March 1, 2009Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Enrollment
- 122
- Primary Endpoint
- changes in anthropometric parameters
Study Overview
Brief Summary
The purpose of this study is to determine the utility of an hypocaloric diet with or without bread in patients with overweight and obesity
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
group bread
Experimental
group who received an hypocaloric balanced diet including bread
Intervention: hypocaloric diet balanced + nutrition education + ruled physical activity (Other)
group without bread
Active Comparator
group who received a hypocaloric balanced diet with exclusion of bread
Intervention: hypocaloric diet balanced + nutrition education + ruled physical activity (Other)
Outcomes
Primary Outcomes
changes in anthropometric parameters
Time Frame: after 16 weeks of start the diet
weight, height, BMI, fat mass, lean mass.
Secondary Outcomes
- Adherence(after 16 weeks of start the diet)
- changes in biochemical parameters(after 16 weeks of start the diet)
- change in satiety and hunger Test(after 16 weeks of start the diet)
Investigators
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