ClinicalTrials.gov
ClinicalTrials.gov Menu

Protein Supplementation Post Bariatric Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02951663
Recruitment Status : Active, not recruiting
First Posted : November 1, 2016
Last Update Posted : September 18, 2018
Sponsor:
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

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.


Condition or disease Intervention/treatment Phase
Bariatric Surgery Candidate Dietary Supplement: Protein Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Protein Supplement
Ready to drink blinded protein supplement
Dietary Supplement: Protein
No Intervention: Control
Control group



Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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)

Information from the National Library of Medicine

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


Locations
United States, North Carolina
Exercise & Sport Science and GI Surgery UNC Hospitals
Chapel Hill, North Carolina, United States, 27599
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Investigators
Principal Investigator: Abbie Smith-Ryan, PhD University of North Carolina, Chapel Hill

Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT02951663     History of Changes
Other Study ID Numbers: 16-0529
First Posted: November 1, 2016    Key Record Dates
Last Update Posted: September 18, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No