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OpenTrials
Completed

NCT Number: NCT04738656

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

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.

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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity, Morbid Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Diet plan

Dietary Supplement

Mediterranean style is a non-restricted diet plan compared with the open protein diet plan

Primary outcomes

  1. Weekly weight loss

    Time frame: Every week up to 24 weeks

  2. Weight relapse after 36 weeks

    Time frame: 1 time after 36 weeks

Sponsors and collaborators

Lead sponsor

Universitat Politècnica de Catalunya

Other

Collaborators

  • Clinica Dorsia
  • University of Barcelona

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Feb 4, 2021
Registry last updated
Feb 4, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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