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

Assistance Publique - Hôpitaux de Paris

Status and phase: Completed; Phase 3

Conditions: Obesity

Treatments: Behavioral: Protein supplementation and strength training; Dietary Supplement: Protein supplementation

Study type: Interventional

Funder types: Other

Identifiers

NCT01113996

P081108

Details and patient eligibility

About

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

Full 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.

Enrollment: 78 patients

Sex: Female

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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78 participants in 3 patient groups

Standard treatment - usual care

No Intervention group

Protein supplementation

Experimental group

Treatment:

Dietary Supplement: Protein supplementation

Protein supplementation and strength training

Experimental group

Treatment:

Behavioral: Protein supplementation and strength training