Physical Activity and Protein Supplementation After Bariatric Surgery (PAPAB)
NCT ID: NCT02128698
Last Updated: 2016-10-26
Study Results
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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COMPLETED
NA
50 participants
INTERVENTIONAL
2014-03-31
2015-11-30
Brief Summary
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Detailed Description
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Dietary proteins have shown to play an important role in body weight regulation. A protein-rich diet attains satiety and thereby facilitates reduction in overall energy intake. It has also shown to enhance food-induced thermogenesis. Furthermore, a protein-rich diet - ideally in combination with exercise - preserves lean body mass and thus resting energy expenditure leading to an improvement of long-term energy balance. Therefore, protein-rich diets or protein supplements, respectively, might facilitate weight loss, especially body fat loss and protect against loss in muscle mass in patients who underwent bariatric surgery. The aim of the present randomized, placebo-controlled, double blind pilot study was to test the possible benefit of proteins in combination with exercise in patients undergoing bariatric surgery, and to examine, whether computer-assisted exercise is advantageous when comparing it to a usual exercise program using written exercise instructions. Therefore, we study the influence of postoperative protein supplementation in combination with computer-assisted exercise on body composition changes, and body weight reduction, as well as physical fitness, protein status and muscle function in obese patients after bariatric surgery.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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Protein and computer-assisted exercise
Patient group which takes daily protein supplements and is advised to do exercise 4 times per week by using Nintendo Wii Balance Board and Wii Fit Plus Software during 6 months after bariatric surgery.
Protein
Postoperative intake of 25 g per day starting on the first day after hospital discharge until 6 months postoperatively.
Computer-assisted exercise
Postoperative regular computer-assisted exercise using Nintendo Wii Mini, Nintendo Wii Balance Board and Wii Fit Plus Software. Exercise is advised to be done 4 times per week.
Placebo and computer-assisted exercise
Patient group which takes daily control product and is advised to do exercise 4 times per week by using Nintendo Wii Balance Board and Wii Fit Plus Software during 6 months after bariatric surgery.
Placebo
Postoperative intake of 25 g per day starting on the first day after hospital discharge until 6 months postoperatively.
Computer-assisted exercise
Postoperative regular computer-assisted exercise using Nintendo Wii Mini, Nintendo Wii Balance Board and Wii Fit Plus Software. Exercise is advised to be done 4 times per week.
Protein and usual exercise
Patient group which takes daily protein supplements and is advised to do exercise 4 times per week by using written exercise instructions during 6 months after bariatric surgery.
Protein
Postoperative intake of 25 g per day starting on the first day after hospital discharge until 6 months postoperatively.
Usual exercise
Postoperative regular exercise using written exercise instructions. Exercise is advised to be done 4 times per week.
Placebo and usual exercise
Patient group which takes daily control product and is advised to do exercise 4 times per week by using written exercise instructions during 6 months after bariatric surgery.
Placebo
Postoperative intake of 25 g per day starting on the first day after hospital discharge until 6 months postoperatively.
Usual exercise
Postoperative regular exercise using written exercise instructions. Exercise is advised to be done 4 times per week.
Interventions
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Protein
Postoperative intake of 25 g per day starting on the first day after hospital discharge until 6 months postoperatively.
Placebo
Postoperative intake of 25 g per day starting on the first day after hospital discharge until 6 months postoperatively.
Computer-assisted exercise
Postoperative regular computer-assisted exercise using Nintendo Wii Mini, Nintendo Wii Balance Board and Wii Fit Plus Software. Exercise is advised to be done 4 times per week.
Usual exercise
Postoperative regular exercise using written exercise instructions. Exercise is advised to be done 4 times per week.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Body weight of ≤ 150 kg
* BMI \> 35 kg/m2
* Indication for laparoscopic sleeve gastrectomy and laparoscopic Roux-en-Y gastric bypass. The decision about the type of surgery is performed independent of the study by the surgeons in charge according to the German S3 guideline.
Exclusion Criteria
* Serious gastrointestinal diseases (e.g. Morbus Crohn, Colitis Ulcerosa, etc.)
* Serious musculoskeletal diseases
* Serious heart diseases (Myocardial infarction, stent implantation, stroke, etc.)
* Intake of blood thinning medicine (e.g. ASS, Marcumar, etc.)
18 Years
65 Years
ALL
No
Sponsors
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University Hospital Tuebingen
OTHER
University of Hohenheim
OTHER
Responsible Party
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Principal Investigators
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Alfred Königsrainer, Professor
Role: STUDY_DIRECTOR
Department of General, Visceral, and Transplant Surgery, University Hospital of Tübingen, Tübingen, Germany
Tobias Meile, MD
Role: PRINCIPAL_INVESTIGATOR
Department of General, Visceral, and Transplant Surgery, University Hospital of Tübingen, Tübingen, Germany
Stephan C Bischoff, Professor
Role: STUDY_CHAIR
Department of Nutritional Medicine, University of Hohenheim, Stuttgart, Germany
Locations
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Department of General, Visceral, and Transplant Surgery, University Hospital of Tübingen
Tübingen, , Germany
Countries
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Other Identifiers
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ZEM_Minigrad_CH
Identifier Type: -
Identifier Source: org_study_id