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| Name | Class |
|---|---|
| University of Mary Hardin-Baylor | OTHER |
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The purpose of this study is to examine the rate and concentration of amino acid absorption after a three-week pattern of milk protein supplementation with and without the addition of a single strain probiotic.
The study will be conducted using a randomized, double-blind, crossover study design. Thirty healthy men and women between 18 - 35 years of age will be recruited to participate in this study. Two supplementation protocols that each span three weeks will be completed and separated with a washout period of three weeks. Participants will be assigned in a randomized, double-blind, crossover fashion to ingest a single daily 25-gram dose of a powder milk protein and placebo or a single daily 25-gram dose of a powder milk protein plus a single strain probiotic. Upon arrival for each study visit, participants will have their resting heart rate, blood pressure, body mass, height, and body composition measured. On the day of experimental testing, subjects will arrive to the laboratory in a fasted state. Subjects will rest semi-supine for multiple blood sampling. Following baseline sampling, participants will ingest their respective supplement plus a standard bolus of milk protein (powder form, mixed with 12 fl oz of cold water). Thereafter, blood samples will be taken at 30, 60, 90, 120, 180, and 240 minutes post-ingestion. Study participants will be provided an additional three-week supply of the alternative treatment to begin after observing a three-week washout. After three weeks of supplementation, study participants will return to the laboratory for their remaining testing visit.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Milk Protein + Probiotic | Experimental | Arm receiving investigational product (probiotic) in the form of a capsule with a dose of 1B Colony Forming Unit (CFU) per day + a 25-gram dose of milk protein concentrate given daily for 3 weeks |
|
| Milk Protein + Placebo | Placebo Comparator | Arm receiving placebo matching investigational product + a 25-gram dose of milk protein concentrate given daily for 3 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Single Strain Probiotic + Milk Protein | Dietary Supplement | • Both conditions matched flavor, color, and serving size |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of amino acid absorption | 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. | Day 0, Day 22, Day 65 |
| Concentration of amino acid absorption | 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. | Day 0, Day 22, Day 65 |
| Measure | Description | Time Frame |
|---|---|---|
| Comprehensive metabolic panel | Comprehensive metabolic panel will be assessed pre vs. post supplementation across the two treatment groups for blood safety data. • All measures are assessed by blood or serum assay analysis | Day 0, Day 22, Day 65 |
| Blood CBC panel |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lem Taylor, PhD | Contact | 254-295-4895 | ltaylor@umhb.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Mary Hardin-Baylor | Belton | Texas | 76513 | United States |
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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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| Placebo + Milk Protein | Dietary Supplement | • Both conditions matched flavor, color, and serving size |
|
Blood CBC panel will be assessed pre vs. post supplementation across the two treatment groups for blood safety data. • All measures are assessed by blood or serum assay analysis |
| Day 0, Day 22, Day 65 |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D008892 | Milk |
| D003611 | Dairy Products |
| D019602 | Food and Beverages |