Pilot Study to Evaluate Daily Protein's Intake Following Bariatric Surgery by Using the Software Protein Assistant

NCT ID: NCT02682160

Last Updated: 2020-07-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-30

Study Completion Date

2016-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The aim of this study is to evaluate the effect of the use of Protein Assistant on the daily protein intake in obese patients who underwent a bariatric surgery (in the 3 months following surgery).

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

After a bariatric surgery, food intake is reduced. Patients should favor proteins to avoid loss of muscles. The guidelines recommend a minimal protein's intake of 60g per day. But this goal is achieved only for 55 to 60 % patients 4 months after surgery and 50 à 65 % patients at one year.

Protein assistant is a software which can calculate the amount of proteins eaten per day and can propose solutions if the intake is insufficient.

The main objective of this study is to evaluate the effect of the use of Protein Assistant on the daily protein intake in obese patients who underwent a bariatric surgery (in the 3 months following surgery).

Protein Assistant is suggested 1 month after bariatric surgery on a digital tablet. The patient is educated to use Protein Assistant. The patient has to complete a dietary record every 2 weeks during 2 months. The aim is to intake 60g per day. If the aim is not reached, Protein assistant suggests qualitative and/or quantitative solutions.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Obesity

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Use of Protein Assistant

patients can use the Protein Assistant during 2 months to evaluate the quantity of protein's intake.

Group Type OTHER

use of Protein Assistant

Intervention Type OTHER

The patient has to complete a dietary record every 2 weeks during 2 months (month 2 and 3 after surgery). The aim is to intake 60g per day. If the aim is not reached, Protein assistant suggests qualitative and/or quantitative solutions.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

use of Protein Assistant

The patient has to complete a dietary record every 2 weeks during 2 months (month 2 and 3 after surgery). The aim is to intake 60g per day. If the aim is not reached, Protein assistant suggests qualitative and/or quantitative solutions.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Patients who underwent a bariatric surgery a month +/- one week ago
* Able to use a digital tablet
* With internet access at home
* Accepting modalities of formation and of digital tablet lending
* When the average of protein intake is under 60g/j on a 3 days dietary record, one month after bariatric surgery

Exclusion Criteria

* Lack of understanding of the use of a digital tablet
* Under the protection of justice
* Person participating to another trial
* Pregnant or breast-feeding women
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University Hospital, Toulouse

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Ana Estrade, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Toulouse

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

CHU Toulouse

Toulouse, , France

Site Status

Countries

Review the countries where the study has at least one active or historical site.

France

References

Explore related publications, articles, or registry entries linked to this study.

Estrade A, Montastier E, Turnin MC, Buisson JC, du Rieu MC, Tuyeras G, Hernandez G, Berard E, Ritz P. An Application May Help Improve Protein Consumption after Bariatric Surgery. Obes Surg. 2019 Jun;29(6):1982-1983. doi: 10.1007/s11695-019-03816-5.

Reference Type RESULT
PMID: 30880355 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

14 7310 02

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Study of Bariatric Surgery
NCT02857179 RECRUITING
Weight Regain Treatment Post-Bariatric Surgery
NCT04662801 COMPLETED PHASE2/PHASE3