NCT04738656

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
78

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2015

Typical duration for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2015

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2019

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

January 25, 2021

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 4, 2021

Completed
Last Updated

February 4, 2021

Status Verified

January 1, 2021

Enrollment Period

3.5 years

First QC Date

January 25, 2021

Last Update Submit

January 29, 2021

Conditions

ObesityObesity, Morbid

Keywords

Endoscopic bariatric treatmentExcess weight lossExcess body mass indexMediterranean diet planOpen protein diet plan

Outcome Measures

Primary Outcomes (2)

  • Weekly weight loss

    Every week up to 24 weeks

  • Weight relapse after 36 weeks

    1 time after 36 weeks

Study Arms (2)

Mediterranean-style diet plan

Mediterranean-style diet plan (6 months): 22% proteins, 53% carbohydrates, and 25% of lipids. 52 participants.

Dietary Supplement: 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

Interventions

Diet planDIETARY_SUPPLEMENT

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

Mediterranean-style diet planOpen protein diet plan

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

  • lack of compliance with the dietary treatment
  • adverse effects of the surgery
  • refuse to complete the treatment
  • lack of adherence

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

ObesityObesity, Morbid

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

January 25, 2021

First Posted

February 4, 2021

Study Start

July 1, 2015

Primary Completion

January 1, 2019

Study Completion

January 1, 2019

Last Updated

February 4, 2021

Record last verified: 2021-01