Trials / Completed
CompletedNCT02128698
Physical Activity and Protein Supplementation After Bariatric Surgery (PAPAB)
Physical Activity and Protein Supplementation After Bariatric Surgery
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 50 (actual)
- Sponsor
- University of Hohenheim · Academic / Other
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
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.
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
Interventions
| Type | Name | Description |
|---|---|---|
| DIETARY_SUPPLEMENT | Protein | Postoperative intake of 25 g per day starting on the first day after hospital discharge until 6 months postoperatively. |
| DIETARY_SUPPLEMENT | 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. |
| BEHAVIORAL | Usual exercise | Postoperative regular exercise using written exercise instructions. Exercise is advised to be done 4 times per week. |
Timeline
- Start date
- 2014-03-01
- Primary completion
- 2015-11-01
- Completion
- 2015-11-01
- First posted
- 2014-05-01
- Last updated
- 2016-10-26
Locations
1 site across 1 country: Germany
Source: ClinicalTrials.gov record NCT02128698. Inclusion in this directory is not an endorsement.