Back to resultsBread in Overweight/Obesity Treatment
Primary Purpose
Overweight, Obesity
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
hypocaloric diet balanced + nutrition education + ruled physical activity
Sponsored by
About this trial
This is an interventional treatment trial for Overweight focused on measuring overweight, obesity, bread, hypocaloric diet
Eligibility 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
group bread
group without bread
Arm Description
group who received an hypocaloric balanced diet including bread
group who received a hypocaloric balanced diet with exclusion of bread
Outcomes
Primary Outcome Measures
changes in anthropometric parameters
weight, height, BMI, fat mass, lean mass.
Secondary Outcome Measures
changes in biochemical parameters
hematocrit, hemoglobin, lipid profile, ghrelin, leptin, adiponectin.
Adherence
Validated scale
change in satiety and hunger Test
visual analogue scale
Full Information
NCT ID
NCT01223989
First Posted
October 13, 2010
Last Updated
October 18, 2010
Sponsor
Fundacion para la Investigacion Biomedica del Hospital Universitario la Paz
1. Study Identification
Unique Protocol Identification Number
NCT01223989
Brief Title
Bread in Overweight/Obesity Treatment
Official Title
Evaluation of the Utility of an Hypocaloric Diet With or Without Bread in Overweight/Obesity Treatment
Study Type
Interventional
2. Study Status
Record Verification Date
October 2010
Overall Recruitment Status
Completed
Study Start Date
March 2009 (undefined)
Primary Completion Date
February 2010 (Actual)
Study Completion Date
February 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Fundacion para la Investigacion Biomedica del Hospital Universitario la Paz
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight, Obesity
Keywords
overweight, obesity, bread, hypocaloric diet
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
122 (Actual)
8. Arms, Groups, and Interventions
Arm Title
group bread
Arm Type
Experimental
Arm Description
group who received an hypocaloric balanced diet including bread
Arm Title
group without bread
Arm Type
Active Comparator
Arm Description
group who received a hypocaloric balanced diet with exclusion of bread
Intervention Type
Other
Intervention Name(s)
hypocaloric diet balanced + nutrition education + ruled physical activity
Primary Outcome Measure Information:
Title
changes in anthropometric parameters
Description
weight, height, BMI, fat mass, lean mass.
Time Frame
after 16 weeks of start the diet
Secondary Outcome Measure Information:
Title
changes in biochemical parameters
Description
hematocrit, hemoglobin, lipid profile, ghrelin, leptin, adiponectin.
Time Frame
after 16 weeks of start the diet
Title
Adherence
Description
Validated scale
Time Frame
after 16 weeks of start the diet
Title
change in satiety and hunger Test
Description
visual analogue scale
Time Frame
after 16 weeks of start the diet
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carmen Gómez Candela, PhD
Organizational Affiliation
Jefe Unidad Nutrición Clínica y Dietética Hospital Universitario La Paz
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
PubMed Identifier
22209501
Citation
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.
Results Reference
derived
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Bread in Overweight/Obesity Treatment
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