Physical Activity and Protein Supplementation After Bariatric Surgery (PAPAB)

NCT02128698 | Completed

• 1 other identifier: ZEM_Minigrad_CH
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Bariatric Surgery Candidate

Keywords

Bariatric surgery; Protein supplementation; Physical activity; Muscle mass; Weight loss; Physical fitness; Muscle strength

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Relative weight loss [%]

  At month 6

• Grip strength [lb]

  At month 6

• Grip strength endurance [sec]

  At month 6

• Physical fitness [repetitions per 30 sec] / [distance in meters]

  At month 6

Other Outcomes (8)

• Blood proteins

  At month 6

• Urea and creatinine excretion

  At month 6

• Frequency of exercise

  During the whole study period of 6 months

Study Arms (4)

Protein and computer-assisted exercise

EXPERIMENTAL

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; Behavioral: Computer-assisted exercise

Placebo and computer-assisted exercise

PLACEBO COMPARATOR

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; Behavioral: Computer-assisted exercise

Protein and usual exercise

ACTIVE COMPARATOR

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; Behavioral: Usual exercise

Placebo and usual exercise

ACTIVE COMPARATOR

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; Behavioral: Usual exercise

Interventions

Protein DIETARY_SUPPLEMENT

Postoperative intake of 25 g per day starting on the first day after hospital discharge until 6 months postoperatively.

Also known as: Resource Instant Protein 88, Néstle Health Nutrition

Protein and computer-assisted exercise; Protein and usual exercise

Placebo DIETARY_SUPPLEMENT

Postoperative intake of 25 g per day starting on the first day after hospital discharge until 6 months postoperatively.

Also known as: Resource Maltodextrin, Néstle Health Nutrition

Placebo and computer-assisted exercise; Placebo and usual exercise

Computer-assisted exercise BEHAVIORAL

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 and computer-assisted exercise; Protein and computer-assisted exercise

Usual exercise BEHAVIORAL

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

Placebo and usual exercise; Protein and usual exercise

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.)

Sponsors & Collaborators

• University of Hohenheim: lead
• University Hospital Tuebingen: collaborator

Study Sites (1)

Department of General, Visceral, and Transplant Surgery, University Hospital of Tübingen

Tübingen, 72076, Germany

Location

MeSH Terms

Conditions

Motor Activity; Weight Loss

Interventions

Proteins

Condition Hierarchy (Ancestors)

Behavior; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Amino Acids, Peptides, and Proteins

Study Officials

• Alfred Königsrainer, Professor

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

  STUDY DIRECTOR

• Tobias Meile, MD

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

  PRINCIPAL INVESTIGATOR

• Stephan C Bischoff, Professor

  Department of Nutritional Medicine, University of Hohenheim, Stuttgart, Germany

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2014
• First Posted: May 1, 2014
• Study Start: March 1, 2014
• Primary Completion: November 1, 2015
• Study Completion: November 1, 2015
• Last Updated: October 26, 2016

Record last verified: 2016-10

Locations

DE (1)