Protein Supplementation Post Bariatric Surgery
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|ClinicalTrials.gov Identifier: NCT02951663|
Recruitment Status : Active, not recruiting
First Posted : November 1, 2016
Last Update Posted : September 18, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Bariatric Surgery Candidate||Dietary Supplement: Protein||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||48 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Care Provider)|
|Primary Purpose:||Supportive Care|
|Official Title:||Evaluation of Body Composition and Metabolism Following Bariatric Surgery, Effects of a Protein Supplement: A Feasibility Study|
|Study Start Date :||October 2016|
|Estimated Primary Completion Date :||January 2019|
|Estimated Study Completion Date :||January 2019|
Experimental: Protein Supplement
Ready to drink blinded protein supplement
Dietary Supplement: Protein
No Intervention: Control
- Number of patients reporting gastrointestinal effects during use of supplementation [ Time Frame: 12 weeks ]Tracked using a custom survey
- Number of shakes consumed out of the total number of shakes provided [ Time Frame: 12 weeks ]
- Body fat [ Time Frame: 12 weeks ]measured using ultrasound
- Lean body mass [ Time Frame: 12 weeks ]measured using ultrasound
- Metabolism (resting metabolic rate) [ Time Frame: 12 weeks ]
- Functional fitness (sit to stand test) [ Time Frame: 12 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02951663
|United States, North Carolina|
|Exercise & Sport Science and GI Surgery UNC Hospitals|
|Chapel Hill, North Carolina, United States, 27599|
|Principal Investigator:||Abbie Smith-Ryan, PhD||University of North Carolina, Chapel Hill|