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

NCT04427020 | Completed

• 1 other identifier: IRB-20-15
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Amino Acid Absorption

Outcome Measures

Primary Outcomes (2)

• Rate of amino acid absorption

  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.

  seven weeks

• Concentration of amino acid absorption

  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.

  seven weeks

Study Arms (2)

Milk Protein + Probiotic

EXPERIMENTAL

25 gram dose of milk protein concentrate with bacillus coagulans GBI-30, 6086

Dietary Supplement: Milk protein + GBI-30

Milk Protein

ACTIVE COMPARATOR

25 gram dose of milk protein concentrate

Dietary Supplement: Milk protein

Interventions

Milk protein + GBI-30 DIETARY_SUPPLEMENT

Both conditions matched flavor, color, and serving size

Milk Protein + Probiotic

Milk protein DIETARY_SUPPLEMENT

Both conditions matched flavor, color, and serving size

Milk Protein

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Lindenwood University: lead

Study Sites (1)

Lindenwood University

Saint Charles, Missouri, 63301, United States

Location

Related Publications (1)

• 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.

  PMID: 33110439 DERIVED

MeSH Terms

Interventions

Milk Proteins

Intervention Hierarchy (Ancestors)

Animal Proteins, Dietary; Dietary Proteins; Proteins; Amino Acids, Peptides, and Proteins; Food; Diet, Food, and Nutrition; Physiological Phenomena; Milk; Dairy Products; Food and Beverages

Study Officials

• Chad Kerksick, PhD

  Laboratory Director

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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.
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 1, 2020
• First Posted: June 11, 2020
• Study Start: August 8, 2019
• Primary Completion: December 3, 2019
• Study Completion: December 3, 2019
• Last Updated: June 11, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)