Physical Activity and Protein Supplementation After Bariatric Surgery (PAPAB)

Study Overview
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Brief Summary
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The purpose of this study is to determine wether regular physical activity in combination with protein supplementation after bariatric surgery can reduce the loss of muscle mass and wether a computer-assisted exercise program is more effective than a usual exercise program regarding frequency of physical activity, fitness and muscular strength.

Detailed Description
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Bariatric surgery has become a major treatment option for severe obesity in adults. Despite the advantages of bariatric surgery, attention needs to be paid to the possible risks following the surgical treatment. Postoperative risks include protein deficiency and pronounced muscle mass loss. Indeed, numerous studies indicate a significant reduction in lean body mass resulting from protein deficiency after bariatric surgery. 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.

Official Title
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Physical Activity and Protein Supplementation After Bariatric Surgery

Conditions
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Bariatric Surgery Candidate

Intervention / Treatment
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* Dietary Supplement: Protein
* Dietary Supplement: Placebo
* Behavioral: Computer-assisted exercise
* Behavioral: Usual exercise


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age of 18 - 65 years 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: Kidney diseases of any kind 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.)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Protein and computer-assisted exercise<br>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. | Dietary Supplement: Protein<br>* Postoperative intake of 25 g per day starting on the first day after hospital discharge until 6 months postoperatively.<br>* Other names: Resource Instant Protein 88, Néstle Health Nutrition;Behavioral: Computer-assisted exercise<br>* 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.<br>|
| Placebo Comparator: Placebo and computer-assisted exercise<br>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. | Dietary Supplement: Placebo<br>* Postoperative intake of 25 g per day starting on the first day after hospital discharge until 6 months postoperatively.<br>* Other names: Resource Maltodextrin, Néstle Health Nutrition;Behavioral: Computer-assisted exercise<br>* 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.<br>|
| Active Comparator: Protein and usual exercise<br>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. | Dietary Supplement: Protein<br>* Postoperative intake of 25 g per day starting on the first day after hospital discharge until 6 months postoperatively.<br>* Other names: Resource Instant Protein 88, Néstle Health Nutrition;Behavioral: Usual exercise<br>* Postoperative regular exercise using written exercise instructions. Exercise is advised to be done 4 times per week.<br>|
| Active Comparator: Placebo and usual exercise<br>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. | Dietary Supplement: Placebo<br>* Postoperative intake of 25 g per day starting on the first day after hospital discharge until 6 months postoperatively.<br>* Other names: Resource Maltodextrin, Néstle Health Nutrition;Behavioral: Usual exercise<br>* Postoperative regular exercise using written exercise instructions. Exercise is advised to be done 4 times per week.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lean body mass loss expressed as percentage of weight loss [%] | Lean body mass is measured by using body impedance analysis. The content of lean body mass in lost weight is calculated using the lost weight in kg and the lost lean body mass in kg. | At month 6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relative weight loss [%] |  | At month 6 | 
| Grip strength [lb] | Grip strength [lb] is measured by using a hydraulic force measuring device. | At month 6 | 
| Grip strength endurance [sec] | Grip strength endurance [sec] is measured by using a hydraulic force measuring device. | At month 6 | 
| Physical fitness [repetitions per 30 sec] / [distance in meters] | Physical fitness is assessed by the 30 Second Sit to Stand Test and the 6 Minute Walk Test (6MWT). The results of these tests are stated as repetitions per 30 seconds, and distance in meters, respectively. | At month 6 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bariatric surgery, Protein supplementation, Physical activity, Muscle mass, Weight loss, Physical fitness, Muscle strength