Bariatric Surgery CandidatePAPABNCT02128698
Physical Activity and Protein Supplementation After Bariatric Surgery (PAPAB)
A study testing Protein, Computer-assisted exercise and Usual exercise in people with Bariatric Surgery Candidate, run by University of Hohenheim at 1 site in Germany.
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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Bariatric Surgery Candidate
- What is being tested?
- Protein, Computer-assisted exercise and Usual exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteGermany
- Study dates
- Mar 2014to Nov 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.)
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of General, Visceral, and Transplant Surgery, University Hospital of Tübingen
Tübingen, 72076
About this study
Official title: 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.
Read the 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.
- Conditions
- Bariatric Surgery Candidate
- Being tested
- Protein, Placebo, Computer-assisted exercise, Usual exercise
- Keywords
- Bariatric surgery, Protein supplementation, Physical activity, Muscle mass, Weight loss, Physical fitness, Muscle strength
- Medical subject headings
- Motor Activity, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProteinDietary supplement
Also called Resource Instant Protein 88, Néstle Health Nutrition
Postoperative intake of 25 g per day starting on the first day after hospital discharge until 6 months postoperatively.
PlaceboDietary supplement
Also called Resource Maltodextrin, Néstle Health Nutrition
Postoperative intake of 25 g per day starting on the first day after hospital discharge until 6 months postoperatively.
Computer-assisted exerciseBehavioural
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 exerciseBehavioural
Postoperative regular exercise using written exercise instructions. Exercise is advised to be done 4 times per week.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Dietary Supplement: Placebo; Behavioral: Usual exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At month 6
Secondary outcomes (4)
Relative weight loss [%]
Measured: At month 6
Grip strength [lb]
Grip strength [lb] is measured by using a hydraulic force measuring device.
Measured: At month 6
Grip strength endurance [sec]
Grip strength endurance [sec] is measured by using a hydraulic force measuring device.
Measured: 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.
Measured: At month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2014 (estimated)
- Study startMar 2014
- Primary completionNov 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bariatric Surgery CandidateStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Hohenheim
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital Tuebingen
- Responsible party
- Sponsor
- Investigators
- Alfred Königsrainer, Professor, Study director, Department of General, Visceral, and Transplant Surgery, University Hospital of Tübingen, Tübingen, GermanyTobias Meile, MD, Principal investigator, Department of General, Visceral, and Transplant Surgery, University Hospital of Tübingen, Tübingen, GermanyStephan C Bischoff, Professor, Study chair, Department of Nutritional Medicine, University of Hohenheim, Stuttgart, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02128698
- Sponsor's protocol ID
- ZEM_Minigrad_CH
- Acronym
- PAPAB
- Status last verified
- Oct 2016
- First submitted
- 29 Apr 2014
- Last updated
- 26 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical Activity and Protein Supplementation After Bariatric Surgery
- ClinicalTrials.gov ID
- NCT02128698
- Acronym / sponsor ID
- PAPAB / ZEM_Minigrad_CH
- Conditions
- Bariatric Surgery Candidate
- Keywords
- Bariatric surgery, Protein supplementation, Physical activity, Muscle mass, Weight loss, Physical fitness, Muscle strength
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of HohenheimUniversity, hospital or other
- Collaborators
- University Hospital Tuebingen
- Study start
- Mar 2014
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 1 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Protein and computer-assisted exercise | Experimental | Dietary Supplement: Protein, Behavioral: Computer-assisted exercisePatient 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. |
| Placebo and computer-assisted exercise | Placebo comparator | Dietary Supplement: Placebo, Behavioral: Computer-assisted exercisePatient 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. |
| Protein and usual exercise | Active comparator | Dietary Supplement: Protein, Behavioral: Usual exercisePatient 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. |
| Placebo and usual exercise | Active comparator | Dietary Supplement: Placebo, Behavioral: Usual exercisePatient 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ProteinAlso: Resource Instant Protein 88, Néstle Health NutritionPostoperative intake of 25 g per day starting on the first day after hospital discharge until 6 months postoperatively. | Dietary supplement | Protein and computer-assisted exercise, Protein and usual exercise |
| PlaceboAlso: Resource Maltodextrin, Néstle Health NutritionPostoperative intake of 25 g per day starting on the first day after hospital discharge until 6 months postoperatively. | Dietary supplement | Placebo and computer-assisted exercise, Placebo and usual exercise |
| Computer-assisted exercisePostoperative 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. | Behavioural | Placebo and computer-assisted exercise, Protein and computer-assisted exercise |
| Usual exercisePostoperative regular exercise using written exercise instructions. Exercise is advised to be done 4 times per week. | Behavioural | Placebo and usual exercise, Protein and usual exercise |
Primary outcome
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.
4 secondary outcomes
Relative weight loss [%]
Time frame: At month 6
Grip strength [lb]
Time frame: At month 6
Grip strength endurance [sec]
Time frame: At month 6
Physical fitness [repetitions per 30 sec] / [distance in meters]
Time frame: At month 6
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alfred Königsrainer, Professor study director
Department of General, Visceral, and Transplant Surgery, University Hospital of Tübingen, Tübingen, Germany
Tobias Meile, MD principal investigator
Department of General, Visceral, and Transplant Surgery, University Hospital of Tübingen, Tübingen, Germany
Stephan C Bischoff, Professor study chair
Department of Nutritional Medicine, University of Hohenheim, Stuttgart, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Protein, Computer-assisted exercise and Usual exercise in people with Bariatric Surgery Candidate, run by University of Hohenheim at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lean body mass loss expressed as percentage of weight loss [%] (time frame: At month 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2016.