Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02128698
Recruitment Status : Completed
First Posted : May 1, 2014
Last Update Posted : October 26, 2016
Sponsor:
Collaborator:
University Hospital Tuebingen
Information provided by (Responsible Party):
University of Hohenheim

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.

Condition or disease Intervention/treatment Phase
Bariatric Surgery Candidate Dietary Supplement: Protein Dietary Supplement: Placebo Behavioral: Computer-assisted exercise Behavioral: Usual exercise Not Applicable

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Prevention
Official Title: Physical Activity and Protein Supplementation After Bariatric Surgery
Study Start Date : March 2014
Actual Primary Completion Date : November 2015
Actual Study Completion Date : November 2015

Resource links provided by the National Library of Medicine


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 Name: 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.
Dietary Supplement: Placebo
Postoperative intake of 25 g per day starting on the first day after hospital discharge until 6 months postoperatively.
Other Name: Resource Maltodextrin, 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.

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 Name: 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 Name: 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.




Primary Outcome Measures :
  1. Lean body mass loss expressed as percentage of weight loss [%] [ Time Frame: At month 6 ]
    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.


Secondary Outcome Measures :
  1. Relative weight loss [%] [ Time Frame: At month 6 ]
  2. Grip strength [lb] [ Time Frame: At month 6 ]
    Grip strength [lb] is measured by using a hydraulic force measuring device.

  3. Grip strength endurance [sec] [ Time Frame: At month 6 ]
    Grip strength endurance [sec] is measured by using a hydraulic force measuring device.

  4. Physical fitness [repetitions per 30 sec] / [distance in meters] [ Time Frame: At month 6 ]
    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.


Other Outcome Measures:
  1. Blood proteins [ Time Frame: At month 6 ]
    Blood proteins, including albumin, prealbumin, transferrin, and total protein, are measured to assess blood protein status.

  2. Urea and creatinine excretion [ Time Frame: At month 6 ]
    Urea and creatinine excretion are measured in 24 h urine samples.

  3. Frequency of exercise [ Time Frame: During the whole study period of 6 months ]
    The frequency of exercise is assessed by using heart rate monitors, which are able to save all exercise data of the patients.

  4. Health related quality of life [ Time Frame: At month 6 ]
    Health related quality of life is assessed by using the standardized questionnaire "short form 36" (SF36).

  5. Body weight related quality of life [ Time Frame: At month 6 ]
    Body weight related quality of life is assessed by using the standardized questionnaire "Impact of Weight on Quality of Life" (IWQOL).

  6. Outcome after bariatric surgery [ Time Frame: At month 6 ]
    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.

  7. Anxiety disorder [ Time Frame: At month 6 ]
    Anxiety is assessed by using the standardized questionnaire "Generalised Anxiety Disorder Assessment" (GAD7).

  8. Mental health [ Time Frame: At month 6 ]
    Mental health is assessed by using the standardized questionnaire "Patient Health Questionnaire" (PHQ9).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02128698


Locations
Layout table for location information
Germany
Department of General, Visceral, and Transplant Surgery, University Hospital of Tübingen
Tübingen, Germany, 72076
Sponsors and Collaborators
University of Hohenheim
University Hospital Tuebingen
Investigators
Layout table for investigator information
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

Layout table for additonal information
Responsible Party: University of Hohenheim
ClinicalTrials.gov Identifier: NCT02128698     History of Changes
Other Study ID Numbers: ZEM_Minigrad_CH
First Posted: May 1, 2014    Key Record Dates
Last Update Posted: October 26, 2016
Last Verified: October 2016
Keywords provided by University of Hohenheim:
Bariatric surgery
Protein supplementation
Physical activity
Muscle mass
Weight loss
Physical fitness
Muscle strength