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OpenTrials
Completed

NCT Number: NCT02951663

Protein Supplementation Post Bariatric Surgery

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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Key information

Conditions

Bariatric Surgery Candidate

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Exercise & Sport Science and GI Surgery UNC Hospitals

Chapel Hill, North Carolina, 27599, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Protein

Dietary Supplement

Primary outcomes

  1. Number of patients reporting gastrointestinal effects during use of supplementation

    Time frame: 12 weeks

    Tracked using a custom survey

  2. Number of shakes consumed out of the total number of shakes provided

    Time frame: 12 weeks

Secondary outcomes

  1. Body fat

    Time frame: 12 weeks

    measured using ultrasound

  2. Lean body mass

    Time frame: 12 weeks

    measured using ultrasound

  3. Metabolism (resting metabolic rate)

    Time frame: 12 weeks

  4. Functional fitness (sit to stand test)

    Time frame: 12 weeks

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Nov 1, 2016
Registry last updated
Mar 20, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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