ObesityNCT04738656
Effectiveness of the Mediterranean Diet on Weight Loss After Endoscopic Bariatric Treatmen
An observational study of Obesity and Obesity, Morbid, run by Universitat Politècnica de Catalunya.
Trial summary
All participants were weighed every week for 24 weeks, wearing light clothes to the nearest 0.1 kg, using a body composition analyzer. Height was determined during the first clinic evaluation using a fixed wall stadiometer to the nearest 0.1 cm, in standing position. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity, Obesity, Morbid
- What is being tested?
- Diet plan
- How many people
- 78 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2015to 1 Jan 2019
- Phase
- Observational
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Primary care clinic. Patients of Dorsia Clinics Surgery and Aesthetic Medicine
Who may be able to join
- no previous gastric intervention
- no hiatus hernias
- not being pregnant or in breastfeeding
- not having cardiac problems, and having regular values in coagulation and blood count,
- having a positive psychological evaluation.
Who cannot join
- lack of compliance with the dietary treatment
- adverse effects of the surgery
- refuse to complete the treatment
- lack of adherence
About this study
Official title: Mediterranean-style and Open Protein Diet Plans on Weight Loss in Patients With Obesity After Endoscopic Bariatric Treatment
All participants were weighed every week for 24 weeks, wearing light clothes to the nearest 0.1 kg, using a body composition analyzer. Height was determined during the first clinic evaluation using a fixed wall stadiometer to the nearest 0.1 cm, in standing position.
Intervention: Participants followed a liquid diet plan during the first week after the endoscopic bariatric procedure (Bioenterics Intragastric Balloon - BIB - or Primary Obesity Surgery Endoluminal - POSE -). Subsequently, subjects were randomly assigned either a Mediterranean-style or a protein diet plan. Energy intake was calculated according to the Spanish Consensus on Bariatric Endoscopy.
The hypothesis of this project is to analyze whether the Mediterranean-style diet is more effective compared with the open protein diet plans in weight loss and weight relapse in subjects with obesity who underwent endoscopic bariatric therapies.
- Conditions
- Obesity, Obesity, Morbid
- Being tested
- Diet plan
- Keywords
- Endoscopic bariatric treatment, Excess weight loss, Excess body mass index, Mediterranean diet plan, Open protein diet plan
- Medical subject headings
- Obesity, Obesity, Morbid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diet planDietary supplement
Mediterranean style is a non-restricted diet plan compared with the open protein diet plan
| Study group | Role | What they receive |
|---|---|---|
| Mediterranean-style diet plan | Mediterranean-style diet plan (6 months): 22% proteins, 53% carbohydrates, and 25% of lipids.
52 participants. Receives: Dietary Supplement: Diet plan | |
| Open protein diet plan | Open protein presents (6 months) 40% of proteins, 29% carbohydrate and 31% of lipids.
26 participants. Receives: Dietary Supplement: Diet plan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weekly weight loss
Measured: Every week up to 24 weeks
Weight relapse after 36 weeks
Measured: 1 time after 36 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2021
- Study start1 Jul 2015
- Primary completion1 Jan 2019
- Study completion1 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitat Politècnica de Catalunya
- Sponsor type
- University, hospital or other
- Collaborators
- University of Barcelona, Clinica Dorsia
- Responsible party
- Principal investigator, Antonio Sanchez Egea, Universitat Politècnica de Catalunya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04738656
- Sponsor's protocol ID
- UPCatalunya
- Status last verified
- Jan 2021
- First submitted
- 25 Jan 2021
- Last updated
- 4 Feb 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: By email: antonio.egea@upc.edu
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mediterranean-style and Open Protein Diet Plans on Weight Loss in Patients With Obesity After Endoscopic Bariatric Treatment
- ClinicalTrials.gov ID
- NCT04738656
- Acronym / sponsor ID
- UPCatalunya
- Conditions
- Obesity, Obesity, Morbid
- Keywords
- Endoscopic bariatric treatment, Excess weight loss, Excess body mass index, Mediterranean diet plan, Open protein diet plan
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Universitat Politècnica de CatalunyaUniversity, hospital or other
- Collaborators
- University of Barcelona, Clinica Dorsia
- Study start
- 1 Jul 2015 (actual)
- Primary completion
- 1 Jan 2019 (actual)
- Study completion
- 1 Jan 2019 (actual)
- First posted
- 4 Feb 2021 (actual)
- 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.
All participants were weighed every week for 24 weeks, wearing light clothes to the nearest 0.1 kg, using a body composition analyzer. Height was determined during the first clinic evaluation using a fixed wall stadiometer to the nearest 0.1 cm, in standing position.
Intervention: Participants followed a liquid diet plan during the first week after the endoscopic bariatric procedure (Bioenterics Intragastric Balloon - BIB - or Primary Obesity Surgery Endoluminal - POSE -). Subsequently, subjects were randomly assigned either a Mediterranean-style or a protein diet plan. Energy intake was calculated according to the Spanish Consensus on Bariatric Endoscopy.
The hypothesis of this project is to analyze whether the Mediterranean-style diet is more effective compared with the open protein diet plans in weight loss and weight relapse in subjects with obesity who underwent endoscopic bariatric therapies.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mediterranean-style diet plan | – | Dietary Supplement: Diet planMediterranean-style diet plan (6 months): 22% proteins, 53% carbohydrates, and 25% of lipids. 52 participants. |
| Open protein diet plan | – | Dietary Supplement: Diet planOpen protein presents (6 months) 40% of proteins, 29% carbohydrate and 31% of lipids. 26 participants. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Primary care clinic. Patients of Dorsia Clinics Surgery and Aesthetic Medicine
Key inclusion criteria (5 listed)
- no previous gastric intervention
- no hiatus hernias
- not being pregnant or in breastfeeding
- not having cardiac problems, and having regular values in coagulation and blood count,
- having a positive psychological evaluation.
Key exclusion criteria (4 listed)
- lack of compliance with the dietary treatment
- adverse effects of the surgery
- refuse to complete the treatment
- lack of adherence
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 |
|---|---|---|
| Diet planMediterranean style is a non-restricted diet plan compared with the open protein diet plan | Dietary supplement | Mediterranean-style diet plan, Open protein diet plan |
Primary outcome
Weekly weight loss
Time frame: Every week up to 24 weeks
Weight relapse after 36 weeks
Time frame: 1 time after 36 weeks
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 4 Feb 2021.
- Individual participant dataSharing planned: Undecided. By email: antonio.egea@upc.edu
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity and Obesity, Morbid, run by Universitat Politècnica de Catalunya.
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 5 inclusion and 4 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 4 Feb 2021. 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.
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?
Weekly weight loss (time frame: Every week up to 24 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Feb 2021.