Controlled Trial Evaluating the Efficacy of Protein Supplementation in the Short Term After Bariatric Surgery

Obesity Clinical Trial

— PROTISLEEVE  

Official title:

Randomized Controlled Trial Prospective Single-center Open Evaluating the Efficacy of Supplementation (Adapted to the Post-operative Period) Current Protein After Bariatric Surgery Like Sleeve Gastrectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02712086
• Other study ID #: RECHMPL15_0173
• Secondary ID: UF 9590
• Status: Completed
• Phase: N/A
• Start date: October 19, 2016
• Est. completion date: October 30, 2023

Study information

• Verified date: May 2024
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The main objective will be to evaluate the effect at 5 weeks of nutritional management associated with protein supplementation (adapted to the post-operative period) on the maintenance of lean body mass at the whole body in obese patients after a sleeve gastrectomy.

Secondary objectives will assess protein intake, food safety, the effect of protein supplementation on body fat in the entire body and the metabolic rate and the impact on quality of life and post-operative joint pain.

Description:

The main objective will be to evaluate the effect at 5 weeks of nutritional management associated with protein supplementation (adapted to the post-operative period) on the maintenance of lean body mass at the whole body in obese patients after a sleeve gastrectomy.

Secondary objectives will assess protein intake, food safety, the effect of protein supplementation on body fat in the entire body and the metabolic rate and the impact on quality of life and post-operative joint pain.

There is still no study evaluating the protein supplementation adapted patients after sleeve gastrectomy on maintaining lean body mass.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: October 30, 2023
• Est. primary completion date: October 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• surgical management of sleeve gastrectomy kind

Exclusion Criteria:

• food allergies

• Weight> 135 kg (maximum weight supported by the DXA)

• orthopedic prosthesis (hip, knee ...) that would make it impossible to interpret the measurement of DXA

• History of bariatric surgery: adjustable gastric banding, vertical banded gastrectomy ...

Related Conditions & MeSH terms

• Obesity

Intervention

Other:
• protein supplementation
Protein supplementation : Protein intake of 30 grams of protein in addition to the usual inputs (to the recommended amounts of 60 to 120 g per day), upon the resumption of oral intake until the fifth week after sleeve gastrectomy.

Locations

Country	Name	City	State
France	UHMontpellier	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

References & Publications (1)

Maimoun L, Aouinti S, Puech M, Lefebvre P, Deloze M, de Santa Barbara P, Renard E, Christol JP, Myzia J, Picot MC, Mariano-Goulart D, Nocca D. Changes in Lean Tissue Mass, Fat Mass, Biological Parameters and Resting Energy Expenditure over 24 Months Following Sleeve Gastrectomy. Nutrients. 2023 Feb 27;15(5):1201. doi: 10.3390/nu15051201. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in lean mass (kg) will be assessed at the level of whole-body dual-energy X-ray absorptiometry (DXA)		up to 1 month
Secondary	food diary	The actual protein intake will be assessed using a food diary over 5 weeks completed by the patient	5 weeks after the hospital discharge
Secondary	change rate IGF1, IGFBP3	change rate IGF1, IGFBP3 between hospitalization and 1 month of hospital discharge	up to 1 month
Secondary	the quality of life	The evolution of the quality of life will be assessed through a specific scale, Baros score.	up to 1 month
Secondary	the quality of life	The evolution of the quality of life will be assessed through a specific scale, Baros score.	up to 5 years
Secondary	change rate IGF1, IGFBP3	change rate IGF1, IGFBP3 between hospitalization and 5 years follow up	up to 5 years