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

NCT ID: NCT02712086

Last Updated: 2025-04-02

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

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-19

Study Completion Date

2023-10-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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usual dietary management

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

Group Type NO_INTERVENTION

No interventions assigned to this group

care of with usual dietary protein supplementation

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

Group Type EXPERIMENTAL

protein supplementation

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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 ...
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Montpellier

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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David NOCCA

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Montpellier

Locations

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UHMontpellier

Montpellier, , France

Site Status

Countries

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France

References

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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.

Reference Type RESULT
PMID: 36904198 (View on PubMed)

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.

Reference Type RESULT
PMID: 39693376 (View on PubMed)

Other Identifiers

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UF 9590

Identifier Type: OTHER

Identifier Source: secondary_id

RECHMPL15_0173

Identifier Type: -

Identifier Source: org_study_id

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