Protein Supplementation Post Bariatric Surgery

Evaluation of Body Composition and Metabolism Following Bariatric Surgery, Effects of a Protein Supplement: A Feasibility Study

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.

Study Overview

• Status: Completed
• Conditions: Bariatric Surgery Candidate
• Intervention / Treatment: Dietary supplement: Protein

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • Exercise & Sport Science and GI Surgery UNC Hospitals

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; Control group
Experimental: Protein Supplement; Ready to drink blinded protein supplement	Dietary supplement: Protein

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body fat	measured using ultrasound	12 weeks
Lean body mass	measured using ultrasound	12 weeks
Metabolism (resting metabolic rate)		12 weeks
Functional fitness (sit to stand test)		12 weeks

Collaborators and Investigators

• Sponsor: University of North Carolina, Chapel Hill

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: October 1, 2016
• Primary Completion (Actual): February 1, 2019
• Study Completion (Actual): February 1, 2019

Study Registration Dates

• First Submitted: October 27, 2016
• First Submitted That Met QC Criteria: October 30, 2016
• First Posted (Estimate): November 1, 2016

Study Record Updates

• Last Update Posted (Actual): March 20, 2019
• Last Update Submitted That Met QC Criteria: March 18, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: 16-0529

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No