Clinical trial NCT02128698: Physical Activity and Protein Supplementation After Bariatric Surgery (PAPAB)
Official title: Physical Activity and Protein Supplementation After Bariatric Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bariatric Surgery Candidate
Keywords: Bariatric surgery
Protein supplementation
Physical activity
Muscle mass
Weight loss
Physical fitness
Muscle strength
Lead sponsor: University of Hohenheim
Sponsor class: OTHER
Collaborators: name: University Hospital Tuebingen
First posted: 2014-05-01
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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: 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.

Eligibility criteria: 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.)

Primary outcomes:
measure: Lean body mass loss expressed as percentage of weight loss [%]
timeFrame: At month 6
Secondary outcomes:
measure: Relative weight loss [%]
timeFrame: At month 6
measure: Grip strength [lb]
timeFrame: At month 6
measure: Grip strength endurance [sec]
timeFrame: At month 6
measure: Physical fitness [repetitions per 30 sec] / [distance in meters]
timeFrame: At month 6
Other outcomes:
measure: Blood proteins
timeFrame: At month 6
measure: Urea and creatinine excretion
timeFrame: At month 6
measure: Frequency of exercise
timeFrame: During the whole study period of 6 months
measure: Health related quality of life
timeFrame: At month 6
measure: Body weight related quality of life
timeFrame: At month 6
measure: Outcome after bariatric surgery
timeFrame: At month 6
measure: Anxiety disorder
timeFrame: At month 6
measure: Mental health
timeFrame: At month 6
Locations:
city: Tübingen
country: Germany
facility: Department of General, Visceral, and Transplant Surgery, University Hospital of Tübingen
Study officials:
affiliation: Department of General, Visceral, and Transplant Surgery, University Hospital of Tübingen, Tübingen, Germany
name: Alfred Königsrainer, Professor
role: STUDY_DIRECTOR
affiliation: Department of General, Visceral, and Transplant Surgery, University Hospital of Tübingen, Tübingen, Germany
name: Tobias Meile, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Nutritional Medicine, University of Hohenheim, Stuttgart, Germany
name: Stephan C Bischoff, Professor
role: STUDY_CHAIR
References: