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| Name | Class |
|---|---|
| Biohm Health, LLC | UNKNOWN |
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This study is a double-blind, randomized, placebo-controlled, crossover clinical trial of N=40 recreationally active men to be recruited a single investigational center in Ohio (i.e., The Center for Applied Health Sciences).
Subjects will take a daily protein supplement (e.g., 15 g of pea protein or 15 g of pea protein + probiotic blend) for 4 weeks, have a 1-week washout period (i.e. meaning they will not take either supplement), and then take the alternate protein supplement for an additional 4 weeks. Outcome variables include plasma amino acids, muscle damage, muscle recovery, and GI tolerance.
This study is a double-blind, randomized, placebo-controlled, crossover clinical trial of N=40 recreationally active men to be recruited a single investigational center in Ohio (i.e., The Center for Applied Health Sciences).
Subjects will take a daily protein supplement (e.g., 15 g of pea protein or 15 g of pea protein + probiotic blend) for 4 weeks, have a 1-week washout period (i.e. meaning they will not take either supplement), and then take the alternate protein supplement for an additional 4 weeks.
Subjects will attend 6 study visits. During Visit 1, subjects will be screened for participation (i.e., medical history, physical exam, routine blood work, background baseline diet). During Visit 2, subjects will get their vitals measured and become randomized into a treatment group. During visits 3 and 5, subjects will get their blood drawn to measure plasma amino acid (AA) responses before and 30, 60, 90, 120, 180 min post-ingestion of their protein test beverage (i.e., pea protein vs. pea protein + probotic) followed by an exhaustive workout to induce single leg muscle damage. During visits 4 and 6, subjects will get their blood drawn to measure the extent of muscle damage and assess their recovery. Also, during visits 3-6 subjects will undergo subjective assessments [markers of recovery (Perceived Recovery Scale) and visual analog scales (VAS) to assess changes in perceived recovery, GI gas and bloating, fatigue, muscle soreness/tightness, mood, and energy] and lower body girth measurements.
Comprehensive side effect profile/ adverse event monitoring will take place throughout the study duration.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Comparator | Active Comparator | 15 grams of pea protein dissolved in 12 ounces of water. |
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| Active | Experimental | 15 grams of pea protein + probiotic blend (1 billion CFU/capsule - blend of Lactobacillus rhamnosus, Lactobacillus acidophilus, Saccharomyces boulardii, and Bifidobacterium breve) dissolved in 12 ounces of water. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Active Comparator | Dietary Supplement | Consists of 15 grams of pea protein |
|
| Measure | Description | Time Frame |
|---|---|---|
| Plasma amino acids | Plasma amino acid responses before and 30, 60, 90, 120, 180 min post-ingestion of the test product. | Change from baseline to 4 weeks. |
| Lactate dehydrogenase (LDH) | Concentration of LDH in plasma. | Change from baseline to 24 hours after acute exercise. |
| Creatine kinase (CK) | Concentration of CK in plasma. | Change from baseline to 24 hours after acute exercise. |
| Myoglobin | Concentration of myoglobin in plasma. | Change from baseline to 24 hours after acute exercise. |
| Blood Urea Nitrogen (BUN) | Concentration of BUN in plasma. | Change from baseline to 24 hours after acute exercise. |
| Mid thigh circumference | Mid thigh circumference as measured using a tape measure. | Change from baseline to 24 hours after acute exercise. |
| Measure | Description | Time Frame |
|---|---|---|
| Gastro Intestinal Bloating | Gastro-intestinal bloating as measured by a 10 cm visual analogue scale, where higher values represent greater bloating. | Change from baseline to 4 weeks. |
| Gastro Intestinal Flatulence |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Center for Applied Health Sciences | Canfield | Ohio | 44406 | United States |
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Subjects will take a daily protein supplement (e.g., 15 g of pea protein or 15 g of pea protein + probiotic blend) for 4 weeks, have a 1-week washout period (i.e. meaning they will not take either supplement), and then take the alternate protein supplement for an additional 4 weeks.
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Gastro-intestinal flatulence (gas) as measured by a 10 cm visual analogue scale, where higher values represent greater gas.
| Change from baseline to 4 weeks. |
| Fatigue | Fatigue as measured by a 10 cm visual analogue scale, where higher values represent greater fatigue. | Change from baseline to 4 weeks. |
| Muscle Soreness | Fatigue as measured by a 10 cm visual analogue scale, where higher values represent greater fatigue. | Change from baseline to 24 hours after acute exercise. |