Effectiveness of the Mediterranean Diet on Weight Loss After Endoscopic Bariatric Treatmen

Obesity Clinical Trial

Official title:

Mediterranean-style and Open Protein Diet Plans on Weight Loss in Patients With Obesity After Endoscopic Bariatric Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04738656
• Other study ID #: UPCatalunya
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Obesity
• Obesity, Morbid
• Weight Loss

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