Bread in Overweight/Obesity Treatment
Evaluation of the Utility of an Hypocaloric Diet With or Without Bread in Overweight/Obesity Treatment
1 other identifier
interventional
122
0 countries
N/A
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Mar 2009
Shorter than P25 for phase_4
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2010
CompletedFirst Submitted
Initial submission to the registry
October 13, 2010
CompletedFirst Posted
Study publicly available on registry
October 19, 2010
CompletedOctober 19, 2010
October 1, 2010
11 months
October 13, 2010
October 18, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
changes in anthropometric parameters
weight, height, BMI, fat mass, lean mass.
after 16 weeks of start the diet
Secondary Outcomes (3)
changes in biochemical parameters
after 16 weeks of start the diet
Adherence
after 16 weeks of start the diet
change in satiety and hunger Test
after 16 weeks of start the diet
Study Arms (2)
group bread
EXPERIMENTALgroup who received an hypocaloric balanced diet including bread
group without bread
ACTIVE COMPARATORgroup who received a hypocaloric balanced diet with exclusion of bread
Interventions
Eligibility Criteria
You may qualify if:
- age \> 18 years
- sex female
- signed informed consent
- patient with overweight and obesity (IMC: \> 25 \< 39.9)
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
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.
PMID: 22209501DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Carmen Gómez Candela, PhD
Jefe Unidad Nutrición Clínica y Dietética Hospital Universitario La Paz
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
October 13, 2010
First Posted
October 19, 2010
Study Start
March 1, 2009
Primary Completion
February 1, 2010
Study Completion
February 1, 2010
Last Updated
October 19, 2010
Record last verified: 2010-10