Physical Activity and Protein Supplementation After Bariatric Surgery (PAPAB) (PAPAB)

Physical Activity and Protein Supplementation After Bariatric Surgery

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.

Study Overview

• Status: Completed
• Conditions: Bariatric Surgery Candidate
• Intervention / Treatment: Dietary supplement: Protein; Behavioral: Computer-assisted exercise; Dietary supplement: Placebo; Behavioral: Usual exercise

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.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Tübingen, Germany, 72076
    • Department of General, Visceral, and Transplant Surgery, University Hospital of Tübingen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Dietary supplement: Protein; Postoperative intake of 25 g per day starting on the first day after hospital discharge until 6 months postoperatively.; Other Names: Resource Instant Protein 88, Néstle Health Nutrition; Behavioral: 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 Comparator: 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.	Behavioral: 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.; Dietary supplement: Placebo; Postoperative intake of 25 g per day starting on the first day after hospital discharge until 6 months postoperatively.; Other Names: Resource Maltodextrin, Néstle Health Nutrition
Active Comparator: 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.	Dietary supplement: Protein; Postoperative intake of 25 g per day starting on the first day after hospital discharge until 6 months postoperatively.; Other Names: Resource Instant Protein 88, Néstle Health Nutrition; Behavioral: Usual exercise; Postoperative regular exercise using written exercise instructions. Exercise is advised to be done 4 times per week.
Active Comparator: 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.	Dietary supplement: Placebo; Postoperative intake of 25 g per day starting on the first day after hospital discharge until 6 months postoperatively.; Other Names: Resource Maltodextrin, Néstle Health Nutrition; Behavioral: Usual exercise; Postoperative regular exercise using written exercise instructions. Exercise is advised to be done 4 times per week.

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood proteins	Blood proteins, including albumin, prealbumin, transferrin, and total protein, are measured to assess blood protein status.	At month 6
Urea and creatinine excretion	Urea and creatinine excretion are measured in 24 h urine samples.	At month 6
Frequency of exercise	The frequency of exercise is assessed by using heart rate monitors, which are able to save all exercise data of the patients.	During the whole study period of 6 months
Health related quality of life	Health related quality of life is assessed by using the standardized questionnaire "short form 36" (SF36).	At month 6
Body weight related quality of life	Body weight related quality of life is assessed by using the standardized questionnaire "Impact of Weight on Quality of Life" (IWQOL).	At month 6
Outcome after bariatric surgery	Outcome is measured by using the standardized instrument "Bariatric Analysis and Reporting Outcome System" (BAROS) which considers excess weight loss, improvement of obesity-related comorbidities, and health related quality of life.	At month 6
Anxiety disorder	Anxiety is assessed by using the standardized questionnaire "Generalised Anxiety Disorder Assessment" (GAD7).	At month 6
Mental health	Mental health is assessed by using the standardized questionnaire "Patient Health Questionnaire" (PHQ9).	At month 6

Collaborators and Investigators

• Sponsor: University of Hohenheim
• Collaborators: University Hospital Tuebingen
• Investigators: Study Director: Alfred Königsrainer, Professor, Department of General, Visceral, and Transplant Surgery, University Hospital of Tübingen, Tübingen, Germany; Principal Investigator: Tobias Meile, MD, Department of General, Visceral, and Transplant Surgery, University Hospital of Tübingen, Tübingen, Germany; Study Chair: Stephan C Bischoff, Professor, Department of Nutritional Medicine, University of Hohenheim, Stuttgart, Germany

Study record dates

Study Major Dates

• Study Start: March 1, 2014
• Primary Completion (Actual): November 1, 2015
• Study Completion (Actual): November 1, 2015

Study Registration Dates

• First Submitted: April 29, 2014
• First Submitted That Met QC Criteria: April 29, 2014
• First Posted (Estimate): May 1, 2014

Study Record Updates

• Last Update Posted (Estimate): October 26, 2016
• Last Update Submitted That Met QC Criteria: October 25, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Keywords: Physical fitness; Bariatric surgery; Weight loss; Physical activity; Muscle strength; Muscle mass; Protein supplementation
• Other Study ID Numbers: ZEM_Minigrad_CH