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

January 29, 2021 updated by: Antonio Sanchez Egea, Universitat Politècnica de Catalunya

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

78

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Primary care clinic. Patients of Dorsia Clinics Surgery and Aesthetic Medicine

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Mediterranean-style diet plan

Mediterranean-style diet plan (6 months): 22% proteins, 53% carbohydrates, and 25% of lipids.

52 participants.
Dietary supplement: Diet plan
Mediterranean style is a non-restricted diet plan compared with the open protein diet plan
Open protein diet plan

Open protein presents (6 months) 40% of proteins, 29% carbohydrate and 31% of lipids.

26 participants.
Dietary supplement: Diet plan
Mediterranean style is a non-restricted diet plan compared with the open protein diet plan

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Weekly weight loss
Time Frame: Every week up to 24 weeks
Every week up to 24 weeks
Weight relapse after 36 weeks
Time Frame: 1 time after 36 weeks
1 time after 36 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitat Politècnica de Catalunya

Collaborators

University of Barcelona
Clinica Dorsia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2015

Primary Completion (Actual)

January 1, 2019

Study Completion (Actual)

January 1, 2019

Study Registration Dates

First Submitted

January 25, 2021

First Submitted That Met QC Criteria

January 29, 2021

First Posted (Actual)

February 4, 2021

Study Record Updates

Last Update Posted (Actual)

February 4, 2021

Last Update Submitted That Met QC Criteria

January 29, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UPCatalunya

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

By email: antonio.egea@upc.edu

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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