Changes in Amino Acid Absorption After Adding a Probiotic to an Acute Protein Feeding

• ClinicalTrials.gov Identifier: NCT04427020
• Recruitment Status: Completed
• First Posted: June 11, 2020
• Last Update Posted: June 11, 2020
• Sponsor: Lindenwood University
• Information provided by (Responsible Party): Lindenwood University

Study Description

Brief Summary:

The purpose of this study is to examine the pharmacokinetic pattern of amino acid absorption after a two-week pattern of milk protein supplementation with and without the addition of Bacillus coagulans GBI-30, 6086.

Condition or disease	Intervention/treatment	Phase
Amino Acid Absorption	Dietary Supplement: Milk protein + GBI-30; Dietary Supplement: Milk protein	Not Applicable

Detailed Description:

The study will be conducted using a randomized, double-blind, crossover study design. 30 healthy men and women between the ages of 18 - 55 years of age will be recruited to participate in this study. Prior to beginning the study, all participants will sign an IRB-approved informed consent document and complete a healthy history questionnaire to determine study eligibility. Two supplementation protocols that each span two weeks will be completed and separated with a washout period of three weeks. For each study visit, all participants will report to the laboratory between 0600 - 1000 hours after observing an 8 - 10-hour fast. For two weeks prior to each study visit, participants will be assigned in a randomized, double-blind, crossover fashion to ingest a single daily 25-gram dose of a milk protein concentrate or a similar dose of milk protein concentrate plus bacillus coagulans GBI-30, 6086. Upon arrival for each study visit, participants will have their resting heart rate, blood pressure, body mass, height, and body composition measured using bioelectrical impedance analysis (BIA). Upon ingestion of their final assigned supplementation dose, standard multiple sample phlebotomy approaches will used to collect approximately 10mL of venous blood from a forearm vein before (0 min), 30, 60, 90, 120, 180, and 240 minutes after ingestion of their final assigned supplementation dose for that period in the study protocol. Participants will be provided 200 mL of cold water to ingest after each blood collection. Upon processing, all blood samples will be stored at -80 C. All samples will o be discarded according to Institutional Review Board-stipulated guidelines. Study participants will be provided an additional two-week supply of the alternative treatment to begin after observing a three-week washout. After two weeks of supplementation, study participants will return to the laboratory for their remaining testing visit. All subsequent study visits will be completed in a randomized fashion to minimize any order effects from testing.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double (Participant, Investigator)
• Masking Description: Protein and probiotics were delivered separately. Upon arrival a faculty member (who was not an investigator) blinded both the protein and probiotic samples and kept the code sealed in an envelope until all statistical analysis was complete. Once all data collection, data entry, and statistical analysis was completely finished, the study code was broken.
• Primary Purpose: Other
• Official Title: Changes in Amino Acid Absorption After Adding a Probiotic to an Acute Protein Feeding
• Actual Study Start Date: August 8, 2019
• Actual Primary Completion Date: December 3, 2019
• Actual Study Completion Date: December 3, 2019

Arms and Interventions

Arm	Intervention/treatment
Experimental: Milk Protein + Probiotic; 25 gram dose of milk protein concentrate with bacillus coagulans GBI-30, 6086	Dietary Supplement: Milk protein + GBI-30; Both conditions matched flavor, color, and serving size
Active Comparator: Milk Protein; 25 gram dose of milk protein concentrate	Dietary Supplement: Milk protein; Both conditions matched flavor, color, and serving size

Outcome Measures

Primary Outcome Measures :

1. Rate of amino acid absorption [ Time Frame: seven weeks ]
   We intend to determine if the addition of a probiotic to milk protein ingestion changes the rate (in minutes) to which amino acids are absorbed into our bloodstream.
2. Concentration of amino acid absorption [ Time Frame: seven weeks ]
   We intend to determine if the addition of a probiotic to milk protein ingestion changes the extent (concentration in millimoles/Liter) to which amino acids are absorbed into our bloodstream.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 50 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

• All participants will be between the ages of 18-55 years.
• Participants will be healthy and free of disease as determined by evaluation of a medical history.
• Completing at least 30 minutes of moderate exercise three days per week

Exclusion Criteria:

• Those individuals less than 18 and greater than 55 years of age will be excluded.
• Any individual who is currently being treated for or diagnosed with a cardiac disorder or disease
• Any individual who is currently being treated for or diagnosed with a respiratory disorder or disease
• Any individual who is currently being treated for or diagnosed with a circulatory disorder or disease
• Any individual who is currently being treated for or diagnosed with a musculoskeletal disorder or disease
• Any individual who is currently being treated for or diagnosed with a metabolic disorder or disease
• Any individual who is currently being treated for or diagnosed with obesity (defined as body mass index > 30 kg/m and body fat greater than 30%)
• Any individual who is currently being treated for or diagnosed with an immune or autoimmune disorder or disease
• Any individual who is currently being treated for or diagnosed with a psychiatric disorder or disease
• Any individual who is currently being treated for or diagnosed with a hematological disorder or disease
• Any individual who is currently being treated for or diagnosed with a neurological disorder or disease
• Any individual who is currently being treated for or diagnosed with an endocrinological disorder or disease
• Participants who are determined to not be weight stable defined as measured body mass deviating by 2% or more.
• Participants who do not or are not willing to abstain from alcohol, nicotine, and caffeine for 12 hours prior to each visit will be excluded
• Participants who do not or are not willing to abstain from exercise for 12 hours prior to each visit will be excluded.

Contacts and Locations

Locations

United States, Missouri

Lindenwood University

Saint Charles, Missouri, United States, 63301

Sponsors and Collaborators

Lindenwood University

Investigators

• Study Director: Chad Kerksick, PhD; Laboratory Director

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Stecker RA, Moon JM, Russo TJ, Ratliff KM, Mumford PW, Jager R, Purpura M, Kerksick CM. Bacillus coagulans GBI-30, 6086 improves amino acid absorption from milk protein. Nutr Metab (Lond). 2020 Oct 23;17:93. doi: 10.1186/s12986-020-00515-2. eCollection 2020.

• Responsible Party: Lindenwood University
• ClinicalTrials.gov Identifier: NCT04427020
• Other Study ID Numbers: IRB-20-15
• First Posted: June 11, 2020
• Last Update Posted: June 11, 2020
• Last Verified: June 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No
• Plan Description: All approved unidentified study data inside the laboratory will be saved within a research repository bank for future research questions. Otherwise, participant data will be destroyed after three years of study completion to maintain IRB compliance.

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Caseins; Chelating Agents; Sequestering Agents; Molecular Mechanisms of Pharmacological Action