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Bread in Overweight/Obesity Treatment

This study has been completed.
Sponsor:
Information provided by:
Fundacion para la Investigacion Biomedica del Hospital Universitario la Paz
ClinicalTrials.gov Identifier:
NCT01223989
First received: October 13, 2010
Last updated: October 18, 2010
Last verified: October 2010

October 13, 2010
October 18, 2010
March 2009
February 2010   (final data collection date for primary outcome measure)
changes in anthropometric parameters [ Time Frame: after 16 weeks of start the diet ] [ Designated as safety issue: No ]
weight, height, BMI, fat mass, lean mass.
Same as current
Complete list of historical versions of study NCT01223989 on ClinicalTrials.gov Archive Site
  • changes in biochemical parameters [ Time Frame: after 16 weeks of start the diet ] [ Designated as safety issue: No ]
    hematocrit, hemoglobin, lipid profile, ghrelin, leptin, adiponectin.
  • Adherence [ Time Frame: after 16 weeks of start the diet ] [ Designated as safety issue: No ]
    Validated scale
  • change in satiety and hunger Test [ Time Frame: after 16 weeks of start the diet ] [ Designated as safety issue: No ]
    visual analogue scale
Same as current
Not Provided
Not Provided
 
Bread in Overweight/Obesity Treatment
Evaluation of the Utility of an Hypocaloric Diet With or Without Bread in Overweight/Obesity Treatment

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

Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Overweight
  • Obesity
Other: hypocaloric diet balanced + nutrition education + ruled physical activity
  • Experimental: group bread
    group who received an hypocaloric balanced diet including bread
    Intervention: Other: hypocaloric diet balanced + nutrition education + ruled physical activity
  • Active Comparator: group without bread
    group who received a hypocaloric balanced diet with exclusion of bread
    Intervention: Other: hypocaloric diet balanced + nutrition education + ruled physical activity
Loria-Kohen V, Gómez-Candela C, Fernández-Fernández C, Pérez-Torres A, García-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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
122
February 2010
February 2010   (final data collection date for primary outcome measure)

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.
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01223989
HULP 753
No
Carmen Gómez Candela, Fundacion para la Investigacion Biomedica del Hospital La Paz
Fundacion para la Investigacion Biomedica del Hospital Universitario la Paz
Not Provided
Principal Investigator: Carmen Gómez Candela, PhD Jefe Unidad Nutrición Clínica y Dietética Hospital Universitario La Paz
Fundacion para la Investigacion Biomedica del Hospital Universitario la Paz
October 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP