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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05695040
Other study ID # AOI 2020 RODA
Secondary ID 2020-A03239-30
Status Recruiting
Phase N/A
First received
Last updated
Start date December 8, 2023
Est. completion date December 2025

Study information

Verified date December 2023
Source University Hospital, Clermont-Ferrand
Contact Lise Laclautre
Phone 334.73.754.963
Email promo_interne_drci@chu-clermontferrand.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The objective of the study was to improve protein intake after the implementation of a dietary workshop performed on the 15th postoperative day following bariatric surgery.


Recruitment information / eligibility

Status Recruiting
Enrollment 88
Est. completion date December 2025
Est. primary completion date September 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Male or female - Over 18 years of age - Scheduled for bariatric surgery such as sleeve gastrectomy or bypass surgery. - Able to give informed consent to participate in the research. - Enrolled in a Social Security system. Exclusion Criteria: - Inability to travel to participate in the workshop. - Patients with a diet excluding animal proteins (vegetarians, vegans). - Pregnant and lactating women. - Inability to comply with protocol recommendations. - Incapacitated patients. - Major deprived of liberty - Refusal to participate.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
dietary workshop "proteins"
The workshop will have 2 objectives: Information of the importance of protein after bariatric surgery and the different sources of protein in the diet. Manipulation of a tool in the form of a real size and shape stomach (before and after surgery) that patients will be able to fill and manipulate in order to visualize the quantities needed to achieve the sensation of satiety.

Locations

Country Name City State
France CHU clermont-ferrand Clermont-Ferrand

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Clermont-Ferrand

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Protein intake Different measurements of protein intake will be performed at 1, 3, 6, and 12 months in order to observe an improvement in the kinetics of protein intake, the objective being to increase protein intake in the year following surgery and not only at a specific time. 1, 3, 6, and 12 months
Secondary Patient's biometric parameters. Muscle function The patient's muscle mass. Undernutrition Nitrogen balance (ancillary ) Medico-economic evaluation -Evaluate the effect of the diet workshop at 3, 6 and 12 months on: The patient's biometric parameters. Muscle function The patient's muscle mass. Undernutrition Nitrogen balance (ancillary ) Medico-economic evaluation 3, 6 and 12 months
Secondary Qualitative evaluation of the workshop at 12 months 12 months
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