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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
History of Changes
  Purpose

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


Condition Intervention Phase
Overweight
Obesity
 Other: hypocaloric diet balanced + nutrition education + ruled physical activity
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluation of the Utility of an Hypocaloric Diet With or Without Bread in Overweight/Obesity Treatment

Resource links provided by NLM:

MedlinePlus related topics: Obesity
U.S. FDA Resources

Further study details as provided by Fundacion para la Investigacion Biomedica del Hospital Universitario la Paz:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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


Enrollment: 122
Study Start Date: March 2009
Study Completion Date: February 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: group bread
group who received an hypocaloric balanced diet including bread
 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
 Other: hypocaloric diet balanced + nutrition education + ruled physical activity

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01223989

Sponsors and Collaborators
Fundacion para la Investigacion Biomedica del Hospital Universitario la Paz
Investigators
Principal Investigator: Carmen Gómez Candela, PhD Jefe Unidad Nutrición Clínica y Dietética Hospital Universitario La Paz
  More Information

No publications provided by Fundacion para la Investigacion Biomedica del Hospital Universitario la Paz

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Carmen Gómez Candela, Fundacion para la Investigacion Biomedica del Hospital La Paz
ClinicalTrials.gov Identifier: NCT01223989     History of Changes
Other Study ID Numbers: HULP 753
Study First Received: October 13, 2010
Last Updated: October 18, 2010
Health Authority: Spain: Ethics Committee

Keywords provided by Fundacion para la Investigacion Biomedica del Hospital Universitario la Paz:
overweight
obesity
bread
hypocaloric diet

Additional relevant MeSH terms:
Obesity
Overweight
Overnutrition
 Nutrition Disorders
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on May 23, 2013