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Completed

NCT Number: NCT02128698

Physical Activity and Protein Supplementation After Bariatric Surgery (PAPAB)

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Tübingen, 72076, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.)

Treatment and study plan

Protein

Dietary Supplement

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

Placebo

Dietary Supplement

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

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.

Usual exercise

Behavioral

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

Primary outcomes

  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 outcomes

  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 outcomes

  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).

Sponsors and collaborators

Lead sponsor

University of Hohenheim

Other

Collaborators

  • University Hospital Tuebingen

Registry information

Official study title

Physical Activity and Protein Supplementation After Bariatric Surgery

Acronym: PAPAB

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
May 1, 2014
Registry last updated
Oct 26, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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