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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Milk Protein + Probiotic | Experimental | 25 gram dose of milk protein concentrate with bacillus coagulans GBI-30, 6086 |
|
| Milk Protein | Active Comparator | 25 gram dose of milk protein concentrate |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Milk protein + GBI-30 | Dietary Supplement | Both conditions matched flavor, color, and serving size |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chad Kerksick, PhD | Laboratory Director | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lindenwood University | Saint Charles | Missouri | 63301 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33110439 | Derived | 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. |
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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.
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| ID | Term |
|---|---|
| D008894 | Milk Proteins |
| ID | Term |
|---|---|
| D000080224 | Animal Proteins, Dietary |
| D004044 | Dietary Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
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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.
| Milk protein | Dietary Supplement | Both conditions matched flavor, color, and serving size |
|
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D008892 | Milk |
| D003611 | Dairy Products |
| D019602 | Food and Beverages |