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Purpose: To evaluate adherence, tolerability, and total protein intake in bariatric surgery patients provided with ready-to-drink protein supplements, and to evaluate the effects of supplementation on body composition, metabolism, and health outcomes.
Participants: Patients scheduled to under go bariatric surgery aged 18-70 years old. Participants will be included if they agree to comply with the study protocol, are free of medical conditions that may contraindicate participation, and do not plan to become pregnant during the study.
Procedures (methods): Participants will complete five laboratory visits for the current study (pre-screening (visit 1), baseline testing (visit 2), and return visits at 3 weeks (visit 3), 12 weeks (visit 4), and 24 weeks (visit 5) post-surgery). The treatment group will be given a 12 week supply of a high protein, low-carbohydrate, low-fat supplement to be taken once daily during days 3-7 post-surgery, and twice daily weeks 2-12. The treatment group will follow standard of care recommendations put forth by the physician-nutritionist team, but using the provided protein supplement to meet recommendations. The control group will be asked to follow the standard of care recommendations from the physician-nutritionist team.
The primary study endpoints will be adherence, tolerability, and total protein intake in bariatric surgery patients provided with a 12-week supply of ready-to-drink protein supplements. Secondary outcomes will evaluate the effect of a protein supplement on body composition (lean mass, fat mass, percent body fat, visceral fat, muscle thickness), resting metabolic rate, clinical and endocrine blood values, functional fitness, and responses to questionnaires evaluating mood, satiety, functional independence, and health related quality of life.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Protein Supplement | Experimental | Ready to drink blinded protein supplement |
|
| Control | No Intervention | Control group |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Protein | Dietary Supplement |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients reporting gastrointestinal effects during use of supplementation | Tracked using a custom survey | 12 weeks |
| Number of shakes consumed out of the total number of shakes provided | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Body fat | measured using ultrasound | 12 weeks |
| Lean body mass | measured using ultrasound | 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Abbie Smith-Ryan, PhD | University of North Carolina, Chapel Hill | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Exercise & Sport Science and GI Surgery UNC Hospitals | Chapel Hill | North Carolina | 27599 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33158590 | Derived | Hirsch KR, Blue MNM, Trexler ET, Ahuja S, Smith-Ryan AE. Provision of ready-to-drink protein following bariatric surgery: An evaluation of tolerability, body composition, and metabolic rate. Clin Nutr. 2021 Apr;40(4):2319-2327. doi: 10.1016/j.clnu.2020.10.022. Epub 2020 Oct 23. |
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| ID | Term |
|---|---|
| D011506 | Proteins |
| ID | Term |
|---|---|
| D000602 | Amino Acids, Peptides, and Proteins |
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| Metabolism (resting metabolic rate) | 12 weeks |
| Functional fitness (sit to stand test) | 12 weeks |