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

Sponsor

Universitat Politècnica de Catalunya (Other)

Overall Status

Completed

CT.gov ID

NCT04738656

Collaborator

University of Barcelona (Other), Clinica Dorsia (Other)

Enrollment

42.1

Actual Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Obesity Obesity, Morbid	Dietary Supplement: Diet plan

Study Design

Study Type:

Observational

Actual Enrollment :

78 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

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

Actual Study Start Date :

Jul 1, 2015

Actual Primary Completion Date :

Jan 1, 2019

Actual Study Completion Date :

Jan 1, 2019

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

Weekly weight loss [Every week up to 24 weeks]
Weight relapse after 36 weeks [1 time after 36 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.