NCT01113996

Brief Summary

The purpose of the study is to test whether additional protein intake with or without strength training will help to maintain body composition (fat-free mass) after surgical treatment of obesity by gastric by pass. The main hypothesis is that additional protein intake will limit fat-free mass loss during surgery-induced weight loss, and that strength training will have an additional beneficial effect

Trial Health

87
On Track

Trial Health Score

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

Enrollment
78

participants targeted

Target at below P25 for phase_3 obesity

Timeline
Completed

Started May 2010

Longer than P75 for phase_3 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

April 29, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 30, 2010

Completed
1 day until next milestone

Study Start

First participant enrolled

May 1, 2010

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

April 28, 2015

Status Verified

April 1, 2015

Enrollment Period

4.6 years

First QC Date

April 29, 2010

Last Update Submit

April 27, 2015

Conditions

Obesity

Keywords

ObesityGastric by-passBody compositionNutritionPhysical activity

Outcome Measures

Primary Outcomes (1)

  • Changes in fat-free mass at 6 months

    6 months

Secondary Outcomes (5)

  • Variation at 6 months after GBP of other body composition components

    6 months

  • Variation at 6 months after GBP in dietary habits

    6 months

  • Variation at 6 months after GBP in muscular strength and habitual physical activity

    6 months

  • Variation at 6 months after GBP in quality of life and obesity co-morbidities

    6 months

  • Variation at 6 months after GBP in obesity-associated inflammatory markers

    6 months

Study Arms (3)

Standard treatment - usual care

NO INTERVENTION

Protein supplementation

EXPERIMENTAL
Dietary Supplement: Protein supplementation

Protein supplementation and strength training

EXPERIMENTAL
Behavioral: Protein supplementation and strength training

Interventions

Protein supplementation and strength trainingBEHAVIORAL

Protein supplementation and strength training

Protein supplementation and strength training
Protein supplementationDIETARY_SUPPLEMENT

Protein supplementation

Protein supplementation

Eligibility Criteria

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

You may qualify if:

  • Female gender
  • Age between 18 and 60 years
  • Planned obesity treatment by gastric bypass
  • Written informed consent

You may not qualify if:

  • Subject not affiliated with a social security scheme
  • Refusal
  • Regular follow-up not feasible
  • Participation in a structured physical activity program
  • Recent coronary event
  • Uncontrolled hypertension
  • proliferative diabetic retinopathy or disabling neuropathy, treatment by dialysis, orthopedic problems
  • Pregnancy
  • Specific food intolerance to protein products
  • Abnormal cardiac stress test

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

GH-Pitié-Salpêtrière

Paris, 75013, France

Location

Related Publications (2)

  • Bellicha A, Ciangura C, Roda C, Torcivia A, Portero P, Oppert JM. Changes in Cardiorespiratory Fitness After Gastric Bypass: Relations with Accelerometry-Assessed Physical Activity. Obes Surg. 2019 Sep;29(9):2936-2941. doi: 10.1007/s11695-019-03932-2.

    PMID: 31073952DERIVED

  • Oppert JM, Bellicha A, Roda C, Bouillot JL, Torcivia A, Clement K, Poitou C, Ciangura C. Resistance Training and Protein Supplementation Increase Strength After Bariatric Surgery: A Randomized Controlled Trial. Obesity (Silver Spring). 2018 Nov;26(11):1709-1720. doi: 10.1002/oby.22317.

    PMID: 30358153DERIVED

MeSH Terms

Conditions

ObesityMotor Activity

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Jean Michel OPPERT, MD, PhD

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 29, 2010

First Posted

April 30, 2010

Study Start

May 1, 2010

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

April 28, 2015

Record last verified: 2015-04

Locations

FR(1)