Bread in Overweight/Obesity Treatment

NCT ID: NCT01223989

Last Updated: 2010-10-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

122 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-03-31

Study Completion Date

2010-02-28

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

Detailed Description

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Conditions

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Overweight Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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group bread

group who received an hypocaloric balanced diet including bread

Group Type EXPERIMENTAL

hypocaloric diet balanced + nutrition education + ruled physical activity

Intervention Type OTHER

group without bread

group who received a hypocaloric balanced diet with exclusion of bread

Group Type ACTIVE_COMPARATOR

hypocaloric diet balanced + nutrition education + ruled physical activity

Intervention Type OTHER

Interventions

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hypocaloric diet balanced + nutrition education + ruled physical activity

Intervention Type OTHER

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.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Fundacion para la Investigacion Biomedica del Hospital Universitario la Paz

OTHER

Sponsor Role lead

Responsible Party

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Fundacion para la Investigacion Biomedica del Hospital La Paz

Principal Investigators

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Carmen Gómez Candela, PhD

Role: PRINCIPAL_INVESTIGATOR

Jefe Unidad Nutrición Clínica y Dietética Hospital Universitario La Paz

References

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Loria-Kohen V, Gomez-Candela C, Fernandez-Fernandez C, Perez-Torres A, Garcia-Puig J, Bermejo LM. Evaluation of the usefulness of a low-calorie diet with or without bread in the treatment of overweight/obesity. Clin Nutr. 2012 Aug;31(4):455-61. doi: 10.1016/j.clnu.2011.12.002. Epub 2011 Dec 30.

Reference Type DERIVED
PMID: 22209501 (View on PubMed)

Other Identifiers

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HULP 753

Identifier Type: -

Identifier Source: org_study_id