Overview

This trial has been completed.

Condition bariatric surgery candidate
Treatments protein, placebo, computer-assisted exercise, usual exercise
Sponsor University of Hohenheim
Collaborator University Hospital Tuebingen
Start date March 2014
End date November 2015
Trial size 50 participants
Trial identifier NCT02128698, ZEM_Minigrad_CH

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver)
Primary purpose prevention
Arm
(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.
protein 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.
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.
(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.
placebo 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 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.
(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.
protein 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.
usual exercise
Postoperative regular exercise using written exercise instructions. Exercise is advised to be done 4 times per week.
(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.
placebo Resource Maltodextrin, Néstle Health Nutrition
Postoperative intake of 25 g per day starting on the first day after hospital discharge until 6 months postoperatively.
usual exercise
Postoperative regular exercise using written exercise instructions. Exercise is advised to be done 4 times per week.

Primary Outcomes

Measure
Lean body mass loss expressed as percentage of weight loss [%]
time frame: At month 6

Secondary Outcomes

Measure
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

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

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.)

Additional Information

Official title Physical Activity and Protein Supplementation After Bariatric Surgery
Principal investigator Tobias Meile, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by University of Hohenheim.