Clinical trial NCT02951663: Protein Supplementation Post Bariatric Surgery
Official title: Evaluation of Body Composition and Metabolism Following Bariatric Surgery, Effects of a Protein Supplement: A Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bariatric Surgery Candidate
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
First posted: 2016-11-01
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Participant is scheduled for weight loss surgery
* Participant agrees to abstain from extraneous supplementation with creatine, β-hydroxy β-methylbutyrate, carnosine, beta-alanine, taurine, or any other supplement or prescription drug that may significantly influence body composition or metabolic rate
* Participant has provided written and dated informed consent to participate in the study
* Participant is willing and able to comply with the protocol
* Participant agrees to abstain from using caffeine, tobacco, and alcohol for at least 24 hours before testing days
* Participant agrees to abstain from exercise 24 hours prior to each testing visit
* Participant is not currently pregnant and does not desire to become pregnant in the next six months

Exclusion Criteria:

* Physicians on the research team believe that a pre-existing condition may influence participant safety or study outcomes, including previously diagnosed cardiovascular, metabolic, renal, hepatic, or musculoskeletal disorders
* Participant is using, or has used one of the following dietary supplements within 8 weeks prior to enrollment: creatine, β-hydroxy β-methylbutyrate, carnosine, beta-alanine, taurine, or any other supplement or prescription drug that may significantly influence body composition or metabolic rate
* Participant is in, or has participated in another clinical trial within 4 weeks prior to enrollment
* Participant is pregnant or plans on becoming pregnant
* Participant has a known allergy or sensitivity to any ingredient in the test product (determined from health history questionnaire)

Primary outcomes:
measure: Number of patients reporting gastrointestinal effects during use of supplementation
timeFrame: 12 weeks
measure: Number of shakes consumed out of the total number of shakes provided
timeFrame: 12 weeks
Secondary outcomes:
measure: Body fat
timeFrame: 12 weeks
measure: Lean body mass
timeFrame: 12 weeks
measure: Metabolism (resting metabolic rate)
timeFrame: 12 weeks
measure: Functional fitness (sit to stand test)
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: Exercise & Sport Science and GI Surgery UNC Hospitals
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Abbie Smith-Ryan, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.