OverweightPhase 4NCT01223989
Bread in Overweight/Obesity Treatment
A Phase 4 study testing hypocaloric diet balanced + nutrition education + ruled physical activity in people with Overweight and Obesity, run by Fundacion para la Investigacion Biomedica del Hospital Universitario la Paz.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Overweight, Obesity
- What is being tested?
- hypocaloric diet balanced + nutrition education + ruled physical activity
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 122 participants
- Where
- No sites listed yet
- Study dates
- Mar 2009to Feb 2010
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age > 18 years
- sex female
- signed informed consent
- patient with overweight and obesity (IMC: > 25 < 39.9)
Who cannot join
- 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).
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- 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.
About this study
Official title: 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
- Conditions
- Overweight, Obesity
- Being tested
- hypocaloric diet balanced + nutrition education + ruled physical activity
- Keywords
- overweight, obesity, bread, hypocaloric diet
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hypocaloric diet balanced + nutrition education + ruled physical activityOther
| Study group | Role | What they receive |
|---|---|---|
| group bread | Experimental | group who received an hypocaloric balanced diet including bread Receives: Other: hypocaloric diet balanced + nutrition education + ruled physical activity |
| group without bread | Active comparator | group who received a hypocaloric balanced diet with exclusion of bread Receives: Other: hypocaloric diet balanced + nutrition education + ruled physical activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
changes in anthropometric parameters
weight, height, BMI, fat mass, lean mass.
Measured: after 16 weeks of start the diet
Secondary outcomes (3)
changes in biochemical parameters
hematocrit, hemoglobin, lipid profile, ghrelin, leptin, adiponectin.
Measured: after 16 weeks of start the diet
Adherence
Validated scale
Measured: after 16 weeks of start the diet
change in satiety and hunger Test
visual analogue scale
Measured: after 16 weeks of start the diet
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2010 (estimated)
- Study startMar 2009
- Primary completionFeb 2010
- Study completionFeb 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for OverweightStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundacion para la Investigacion Biomedica del Hospital Universitario la Paz
- Sponsor type
- University, hospital or other
- Investigators
- Carmen Gómez Candela, PhD, Principal investigator, Jefe Unidad Nutrición Clínica y Dietética Hospital Universitario La Paz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01223989
- Sponsor's protocol ID
- HULP 753
- Status last verified
- Oct 2010
- First submitted
- 13 Oct 2010
- Last updated
- 19 Oct 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 22209501
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Utility of an Hypocaloric Diet With or Without Bread in Overweight/Obesity Treatment
- ClinicalTrials.gov ID
- NCT01223989
- Acronym / sponsor ID
- HULP 753
- Conditions
- Overweight, Obesity
- Keywords
- overweight, obesity, bread, hypocaloric diet
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- Fundacion para la Investigacion Biomedica del Hospital Universitario la PazUniversity, hospital or other
- Study start
- Mar 2009
- Primary completion
- Feb 2010 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 19 Oct 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the utility of an hypocaloric diet with or without bread in patients with overweight and obesity
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group bread | Experimental | Other: hypocaloric diet balanced + nutrition education + ruled physical activitygroup who received an hypocaloric balanced diet including bread |
| group without bread | Active comparator | Other: hypocaloric diet balanced + nutrition education + ruled physical activitygroup who received a hypocaloric balanced diet with exclusion of bread |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- age > 18 years
- sex female
- signed informed consent
- patient with overweight and obesity (IMC: > 25 < 39.9)
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| hypocaloric diet balanced + nutrition education + ruled physical activity | Other | group bread, group without bread |
Primary outcome
changes in anthropometric parameters
Time frame: after 16 weeks of start the diet
weight, height, BMI, fat mass, lean mass.
3 secondary outcomes
changes in biochemical parameters
Time frame: after 16 weeks of start the diet
Adherence
Time frame: after 16 weeks of start the diet
change in satiety and hunger Test
Time frame: after 16 weeks of start the diet
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2010.
- Derived from this study: PubMed 22209501Loria-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carmen Gómez Candela, PhD principal investigator
Jefe Unidad Nutrición Clínica y Dietética Hospital Universitario La Paz
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing hypocaloric diet balanced + nutrition education + ruled physical activity in people with Overweight and Obesity, run by Fundacion para la Investigacion Biomedica del Hospital Universitario la Paz.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Oct 2010. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
changes in anthropometric parameters (time frame: after 16 weeks of start the diet). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01223989, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2010.