NCT02712086

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable obesity

Timeline
Completed

Started Oct 2016

Longer than P75 for not_applicable obesity

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

March 14, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 17, 2016

Completed
7 months until next milestone

Study Start

First participant enrolled

October 19, 2016

Completed
7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2023

Completed
Last Updated

April 2, 2025

Status Verified

March 1, 2025

Enrollment Period

7 years

First QC Date

March 14, 2016

Last Update Submit

March 27, 2025

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • food diary

    5 weeks after the hospital discharge

  • change rate IGF1, IGFBP3

    up to 1 month

  • the quality of life

    up to 1 month

  • the quality of life

    up to 5 years

  • change rate IGF1, IGFBP3

    up to 5 years

Study Arms (2)

usual dietary management

NO INTERVENTION

Control group: usual dietary management Following the intervention, the stomach of patients underwent many changes

care of with usual dietary protein supplementation

EXPERIMENTAL

Intervention group: Usual dietary management with protein supplementation (30g) in addition to the usual inputs

Other: protein supplementation

Interventions

protein supplementationOTHER

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.

care of with usual dietary protein supplementation

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • surgical management of sleeve gastrectomy kind

You may not qualify if:

  • 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 ...

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UHMontpellier

Montpellier, 34295, France

Location

Related Publications (2)

  • 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.

    PMID: 36904198RESULT

  • Maimoun L, Aouinti S, Puech M, Lefebvre P, Humbert L, Deloze M, de Santa Barbara P, Maimoun-Nande L, Boudousq V, Cristol JP, Renard E, Picot MC, Mariano-Goulart D, Nocca D. Modification of bone architecture following sleeve gastrectomy: a five-year follow-up. J Bone Miner Res. 2025 Feb 2;40(2):251-261. doi: 10.1093/jbmr/zjae202.

    PMID: 39693376RESULT

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

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

Study Officials

  • David NOCCA

    University Hospital, Montpellier

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 14, 2016

First Posted

March 17, 2016

Study Start

October 19, 2016

Primary Completion

October 30, 2023

Study Completion

October 30, 2023

Last Updated

April 2, 2025

Record last verified: 2025-03

Locations

FR(1)