Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Increnovo LLC | INDUSTRY |
Not provided
Not provided
Not provided
The purpose of this study is to examine the pattern of plasma amino acid appearance after a two-week daily regimen of milk protein concentrate supplementation with and without the addition of Bacillus coagulans GBI-30, 6086 among older women.
Once determined eligible and providing consent, 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. Upon ingestion of their final assigned supplementation dose, standard multiple sample phlebotomy approaches will be used to collect approximately 10mL of venous blood from a forearm vein at specific time intervals up to four hours after ingestion of their final assigned supplementation dose for that period in the study protocol.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Milk Protein | Placebo Comparator | 25-gram dose of milk protein concentrate |
|
| Milk Protein and Probiotic | Experimental | 25-gram dose of milk protein concentrate with bacillus coagulans GBI-30, 6086 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bacillus Coagulans GBI-30, 6086 | Dietary Supplement | In a randomized, double-blind, crossover fashion, study participants will supplement on a daily basis for two weeks during one study period with a 25-gram dose of either milk protein concentrate or a 25-gram dose of milk protein concentrate with bacillus coagulans GBI-30, 6086. Each dose will be ingested at the same time of day with 8 - 12 fluid ounces of cold tap water. All participants will be required to complete a supplementation log to document when each dose of their assigned protein is consumed. Upon completion of their first assigned study protocol period, participants will observe a three-week washout period by returning to their normal dietary intake and physical activity habits before beginning supplementation for the remaining study period. |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma Concentrations of Amino Acids in Blood | Plasma Concentrations of Amino Acids in Blood | 4 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events | Incidence and associations of reported adverse events | 4 hours |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lindenwood University | Saint Charles | Missouri | 63301 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36515888 | Derived | Walden KE, Hagele AM, Orr LS, Gross KN, Krieger JM, Jager R, Kerksick CM. Probiotic BC30 Improves Amino Acid Absorption from Plant Protein Concentrate in Older Women. Probiotics Antimicrob Proteins. 2024 Feb;16(1):125-137. doi: 10.1007/s12602-022-10028-4. Epub 2022 Dec 14. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Randomized, double-blind, crossover study design
Not provided
Not provided
Supplements blinded to participant and investigator by third party
|