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

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

PHASE3

Total Enrollment

78 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-05-31

Study Completion Date

2014-12-31

Brief Summary

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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

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Detailed Description

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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.

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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Standard treatment - usual care

Group Type NO_INTERVENTION

No interventions assigned to this group

Protein supplementation

Group Type EXPERIMENTAL

Protein supplementation

Intervention Type DIETARY_SUPPLEMENT

Protein supplementation

Protein supplementation and strength training

Group Type EXPERIMENTAL

Protein supplementation and strength training

Intervention Type BEHAVIORAL

Protein supplementation and strength training

Interventions

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Protein supplementation and strength training

Intervention Type BEHAVIORAL

Protein supplementation

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No