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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04738656
Other study ID # UPCatalunya
Secondary ID
Status Completed
Phase
First received
Last updated
Start date July 1, 2015
Est. completion date January 1, 2019

Study information

Verified date January 2021
Source Universitat Politècnica de Catalunya
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


Recruitment information / eligibility

Status Completed
Enrollment 78
Est. completion date January 1, 2019
Est. primary completion date January 1, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - 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. Exclusion Criteria: - lack of compliance with the dietary treatment - adverse effects of the surgery - refuse to complete the treatment - lack of adherence

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Diet plan
Mediterranean style is a non-restricted diet plan compared with the open protein diet plan

Locations

Country Name City State
n/a

Sponsors (3)

Lead Sponsor Collaborator
Universitat Politècnica de Catalunya Clinica Dorsia, University of Barcelona

Outcome

Type Measure Description Time frame Safety issue
Primary Weekly weight loss Every week up to 24 weeks
Primary Weight relapse after 36 weeks 1 time after 36 weeks
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