Monitoring Patients Who Are Obese Surgery for Gastric By-pass Protein Supplementation and Physical Training (PROMISE)

Phase 3

Completed

• Conditions: Obesity
• Interventions: Dietary Supplement: Protein supplementation; Behavioral: Protein supplementation and strength training

• Registration Number: NCT01113996
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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

Detailed Description

Design: Open randomised controlled trial comparing, in obese patients after GBP, an additional oral intake of protein with or without a muscular-strengthening physical training programme (18 weeks) to standard medical and nutritional follow-up after bariatric surgery as control (3 groups). Primary outcome: Variation at 6 months after GBP in total and appendicular fat-free mass as assessed by dual-energy X-ray absorptiometry (DXA). Duration of the study: 36 months. Duration of participation for one patient: 7 months. Number of centers: Monocentric study.

Study Timeline

• Study First Submitted: 2010-04-29
• Study First Submitted QC: 2010-04-29
• Study First Posted: 2010-04-30
• Study Start: 2010-05
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-27
• Last Update Posted: 2015-04-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 78

Inclusion Criteria

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

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Exclusion Criteria

• 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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Protein supplementation	Protein supplementation	-
Protein supplementation and strength training	Protein supplementation and strength training	-

Primary Outcome Measures

Name	Time	Method
Changes in fat-free mass at 6 months	6 months

Secondary Outcome Measures

Name	Time	Method
Variation at 6 months after GBP in quality of life and obesity co-morbidities	6 months
Variation at 6 months after GBP in muscular strength and habitual physical activity	6 months
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 obesity-associated inflammatory markers	6 months

Trial Locations

Locations (1)

GH-Pitié-Salpêtrière; 🇫🇷 Paris, France