Physical Activity and Protein Supplementation After Bariatric Surgery (PAPAB)

Bariatric Surgery Candidate Clinical Trial

— PAPAB  

Official title:

Physical Activity and Protein Supplementation After Bariatric Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02128698
• Other study ID #: ZEM_Minigrad_CH
• Status: Completed
• Phase: N/A
• First received: April 29, 2014
• Last updated: October 25, 2016
• Start date: March 2014
• Est. completion date: November 2015

Study information

• Verified date: October 2016
• Source: University of Hohenheim
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: November 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Bariatric Surgery Candidate

Intervention

Dietary Supplement:
• 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.

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.
• Usual exercise
Postoperative regular exercise using written exercise instructions. Exercise is advised to be done 4 times per week.

Locations

Country	Name	City	State
Germany	Department of General, Visceral, and Transplant Surgery, University Hospital of Tübingen	Tübingen

Sponsors (2)

Lead Sponsor	Collaborator
University of Hohenheim	University Hospital Tuebingen

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Blood proteins	Blood proteins, including albumin, prealbumin, transferrin, and total protein, are measured to assess blood protein status.	At month 6	Yes
Other	Urea and creatinine excretion	Urea and creatinine excretion are measured in 24 h urine samples.	At month 6	Yes
Other	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	Yes
Other	Health related quality of life	Health related quality of life is assessed by using the standardized questionnaire "short form 36" (SF36).	At month 6	Yes
Other	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	Yes
Other	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	Yes
Other	Anxiety disorder	Anxiety is assessed by using the standardized questionnaire "Generalised Anxiety Disorder Assessment" (GAD7).	At month 6	Yes
Other	Mental health	Mental health is assessed by using the standardized questionnaire "Patient Health Questionnaire" (PHQ9).	At month 6	Yes
Primary	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	Yes
Secondary	Relative weight loss [%]		At month 6	Yes
Secondary	Grip strength [lb]	Grip strength [lb] is measured by using a hydraulic force measuring device.	At month 6	Yes
Secondary	Grip strength endurance [sec]	Grip strength endurance [sec] is measured by using a hydraulic force measuring device.	At month 6	Yes
Secondary	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	Yes