Bread in Overweight/Obesity Treatment

Phase 4

Completed

• Conditions: Overweight; Obesity
• Interventions: Other: hypocaloric diet balanced + nutrition education + ruled physical activity

• Registration Number: NCT01223989
• Lead Sponsor: Fundacion para la Investigacion Biomedica del Hospital Universitario la Paz

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

Detailed Description

Not available

Study Timeline

• Study Start: 2009-03
• Primary Completion: 2010-02
• Study Completion: 2010-02
• Status Verified: 2010-10
• Study First Submitted: 2010-10-13
• Study First Submitted QC: 2010-10-18
• Last Update Submitted: 2010-10-18
• Study First Posted: 2010-10-19
• Last Update Posted: 2010-10-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 122

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
group bread	hypocaloric diet balanced + nutrition education + ruled physical activity	group who received an hypocaloric balanced diet including bread
group without bread	hypocaloric diet balanced + nutrition education + ruled physical activity	group who received a hypocaloric balanced diet with exclusion of bread

Primary Outcome Measures

Name	Time	Method
changes in anthropometric parameters	after 16 weeks of start the diet	weight, height, BMI, fat mass, lean mass.

Secondary Outcome Measures

Name	Time	Method
Adherence	after 16 weeks of start the diet	Validated scale
changes in biochemical parameters	after 16 weeks of start the diet	hematocrit, hemoglobin, lipid profile, ghrelin, leptin, adiponectin.
change in satiety and hunger Test	after 16 weeks of start the diet	visual analogue scale