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

Study Overview
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Brief Summary
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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.

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

Conditions
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Obesity, Obesity, Morbid

Intervention / Treatment
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* Dietary Supplement: Diet plan


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Mediterranean-style diet plan<br>Mediterranean-style diet plan (6 months): 22% proteins, 53% carbohydrates, and 25% of lipids. 52 participants. | Dietary Supplement: Diet plan<br>* Mediterranean style is a non-restricted diet plan compared with the open protein diet plan<br>|
| Open protein diet plan<br>Open protein presents (6 months) 40% of proteins, 29% carbohydrate and 31% of lipids. 26 participants. | Dietary Supplement: Diet plan<br>* Mediterranean style is a non-restricted diet plan compared with the open protein diet plan<br>|

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Endoscopic bariatric treatment, Excess weight loss, Excess body mass index, Mediterranean diet plan, Open protein diet plan