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Completed

NCT Number: NCT01113996

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

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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Key information

Conditions

Obesity Behavior Body Weight Motor Activity Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

GH-Pitié-Salpêtrière

Paris, 75013, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Protein supplementation and strength training

Behavioral

Protein supplementation and strength training

Protein supplementation

Dietary Supplement

Protein supplementation

Primary outcomes

  1. Changes in fat-free mass at 6 months

    Time frame: 6 months

Secondary outcomes

  1. Variation at 6 months after GBP of other body composition components

    Time frame: 6 months

  2. Variation at 6 months after GBP in dietary habits

    Time frame: 6 months

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

    Time frame: 6 months

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

    Time frame: 6 months

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

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

Optimization of Monitoring Patients Who Are Obese Surgery for Gastric By-pass Protein Supplementation and Physical Training: Interventional Randomized Trial

Acronym: PROMISE

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
Apr 30, 2010
Registry last updated
Apr 28, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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