Protein Supplementation Post Bariatric Surgery

NCT02951663 | Completed

• 1 other identifier: 16-0529
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Bariatric Surgery Candidate

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Body fat

  12 weeks

• Lean body mass

  12 weeks

• Metabolism (resting metabolic rate)

  12 weeks

• Functional fitness (sit to stand test)

  12 weeks

Study Arms (2)

Protein Supplement

EXPERIMENTAL

Ready to drink blinded protein supplement

Dietary Supplement: Protein

Control

NO INTERVENTION

Control group

Interventions

Protein DIETARY_SUPPLEMENT

Protein Supplement

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead

Study Sites (1)

Exercise & Sport Science and GI Surgery UNC Hospitals

Chapel Hill, North Carolina, 27599, United States

Location

Related Publications (1)

• 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.

  PMID: 33158590 DERIVED

MeSH Terms

Interventions

Proteins

Intervention Hierarchy (Ancestors)

Amino Acids, Peptides, and Proteins

Study Officials

• Abbie Smith-Ryan, PhD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 27, 2016
• First Posted: November 1, 2016
• Study Start: October 1, 2016
• Primary Completion: February 1, 2019
• Study Completion: February 1, 2019
• Last Updated: March 20, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)