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Complex oligosaccharides can alter the gut microbiome by aiding in the growth of certain organisms, and possibly, inhibiting others. The synergy with a probiotic may enhance gastrointestinal colonization.
The study will evaluate the synergy of the use of a complex oligosaccharide with and without a probiotic on the human microbiome in healthy volunteers. The combination should support general gastrointestinal health.
The study a multi-dose randomized cohort trial using 10 subjects per cohort for a total of 60 healthy adult volunteers ages 18-44.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 (Probiotic) | Experimental | Day 1-7: Subjects receive standard probiotic dose (mixed in aqueous diluent) orally once daily |
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| Cohort 2 (Complex oligosaccharide) | Experimental | Day 1-14: Subjects receive 18 g dose of complex oligosaccharide orally twice daily |
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| Cohort 3 (4.5 g Dose of Complex oligosaccharide + Probiotic) | Experimental | Day 1-7: Subjects receive standard probiotic dose (mixed in aqueous diluent) orally once daily in combination with 4.5 g dose of complex oligosaccharide orally twice daily Day 8-14: Subjects receive only 4.5 g dose of complex oligosaccharide orally twice daily |
|
| Cohort 4 (9 g dose of Complex oligosaccharide + Probiotic) | Experimental | Day 1-7: Subjects receive standard probiotic dose (mixed in aqueous diluent) orally once daily in combination with 9 g dose of complex oligosaccharide orally twice daily Day 8-14: Subjects receive only 9 g dose of complex oligosaccharide orally twice daily |
|
| Cohort 5 (18 g dose of Complex oligosaccharide + PPI + Probiotic +/- H2 Blocker) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Complex oligosaccharide | Dietary Supplement | Complex oligosaccharide concentrate |
|
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of the Levels of B.Infantis in Stool by Quantitative PCR | qPCR analysis uses primers for species and strain on DNA extracted from stool samples and is reported as genome copies per nanogram of DNA. The higher the value, the greater indication of engraftment of B.infantis signal over time indicating retention of introduced species. | All Cohorts - Day 1, 5, 8, 15 and 29; Cohort 5 - additionally Days 33, 36, 43, 50 and 57 |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Concentration of Blood Parameters From Day 1 to Day 15 | Blood samples are collected and tested for analysis of the levels of cytokines using Luminex-based chemistry to assess for immunology screening and safety monitoring of liver function, renal function, and electrolytes and glucose. | Day 1 - 15 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| WCCT Global | Cypress | California | 90630 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Cohort 1 (Probiotic) | Day 1-7: Subjects receive standard probiotic dose (mixed in aqueous diluent) orally once daily |
| FG001 | Cohort 2 (Complex Oligosaccharide) | Day 1-14: Subjects receive 18 g dose of complex oligosaccharide orally twice daily |
| FG002 | Cohort 3 (4.5 g Dose of Complex Oligosaccharide + Probiotic) | Day 1-7: Subjects receive standard probiotic dose (mixed in aqueous diluent) orally once daily in combination with 4.5 g dose of complex oligosaccharide orally twice daily Day 8-14:Subjects receive only 4.5 g dose of complex oligosaccharide orally twice daily |
| FG003 | Cohort 4 (9 g Dose of Complex Oligosaccharide + Probiotic) | Day 1-7: Subjects receive standard probiotic dose (mixed in aqueous diluent) orally once daily in combination with 9 g dose of complex oligosaccharide orally twice daily Day 8-14: Subjects receive only 9 g dose of complex oligosaccharide orally twice daily |
| FG004 | Cohort 5 (18 g Dose of Complex Oligosaccharide + PPI + Probiotic +/- H2 Blocker) | First Course Day 1-7: Subjects receive standard probiotic dose (mixed in aqueous diluent) and PPI orally once daily in combination with 18 g dose of complex oligosaccharide orally twice daily Day 8-14: Subjects receive only 18 g dose of complex oligosaccharide orally twice daily Second Course Day 29-35: Subjects receive standard probiotic dose (mixed in aqueous diluent) and may receive H2 blocker* orally once daily in combination with 18 g dose of complex oligosaccharide orally twice daily Day 36-42: Subjects receive only 18 g dose of complex oligosaccharide orally twice daily *4 subjects received H2 blocker, 4 subjects did not receive H2 blocker during second course |
| FG005 | Cohort 6 (18 g Dose of Complex Oligosaccharide + Probiotic) | Day 1-7: Subjects receive standard probiotic dose (mixed in aqueous diluent) orally once daily in combination with 18 g dose of complex oligosaccharide orally twice daily Day 8-14: Subjects receive only 18 g dose of complex oligosaccharide orally twice daily |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Cohort 1 (Probiotic) | Day 1-7: Subjects receive standard probiotic dose (mixed in aqueous diluent) orally once daily |
| BG001 | Cohort 2 (Complex Oligosaccharide) | Day 1-14: Subjects receive 18 g dose of complex oligosaccharide orally twice daily |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Evaluation of the Levels of B.Infantis in Stool by Quantitative PCR | qPCR analysis uses primers for species and strain on DNA extracted from stool samples and is reported as genome copies per nanogram of DNA. The higher the value, the greater indication of engraftment of B.infantis signal over time indicating retention of introduced species. | Changes in microbiome species abundance and diversity | Posted | Geometric Mean | 95% Confidence Interval | copies/ng DNA | All Cohorts - Day 1, 5, 8, 15 and 29; Cohort 5 - additionally Days 33, 36, 43, 50 and 57 |
|
Cohort 1,2,3,4,6 - 38 days Cohort 5 - 73 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cohort 1 (Probiotic) | Day 1-7: Subjects receive standard probiotic dose (mixed in aqueous diluent) orally once daily |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bacteria Vaginosis | Infections and infestations | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr David Rechtman VP, Medical Affairs | Prolacta Bioscience | 8887765228 | drechtman@prolacta.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 3, 2023 | May 14, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D019936 | Probiotics |
| D006635 | Histamine H2 Antagonists |
| ID | Term |
|---|---|
| D019587 | Dietary Supplements |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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| Experimental |
First Course Day 1-7: Subjects receive standard probiotic dose (mixed in aqueous diluent) and PPI orally once daily in combination with 18 g dose of complex oligosaccharide orally twice daily Day 8-14: Subjects receive only 18 g dose of complex oligosaccharide orally twice daily Second Course Day 29-35: Subjects receive standard probiotic dose (mixed in aqueous diluent) and may receive H2 blocker* orally once daily in combination with 18 g dose of complex oligosaccharide orally twice daily Day 36-42: Subjects receive only 18 g dose of complex oligosaccharide orally twice daily *4 subjects received H2 blocker, 4 subjects did not receive H2 blocker during second course |
|
| Cohort 6 (18 g dose of Complex oligosaccharide + Probiotic) | Experimental | Day 1-7: Subjects receive standard probiotic dose (mixed in aqueous diluent) orally once daily in combination with 18 g dose of complex oligosaccharide orally twice daily Day 8-14: Subjects receive only 18 g dose of complex oligosaccharide orally twice daily |
|
| Probiotic | Dietary Supplement | Probiotic |
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| PPI | Other | Over-the-counter proton pump inhibitor (PPI) |
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| H2 Blocker | Other | Over-the-counter H2 blocker |
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| Summary of the Evaluation of the Use of Proton Pump Inhibitors for Protection of B. Infantis Levels in Cohorts 5 and 6 by Visit |
Evaluation of B. infantis levels in Dose Group 5 will be compared to B. infantis levels in Dose Groups 6 using descriptive statistics including geometric means and 95% confidence intervals of the genome copy number per nanogram of DNA (B. infantis copies/ng DNA). |
| Day 1, 5, 8, 15, 22, 29, 33, 43, 50, 57 |
| Concentrations (µmol/g) of Lactic Acid in Stool Samples From Day 1 to Day 29 | Descriptive statistics including means and standard deviation of lactate (Cohort 1; 0g HMO + B. infantis, Cohort 2; 18 g HMO, engrafted subjects and not engrafted subjects from Cohorts 5 & 6 combined; 18g HMO + B. infantis). Descriptive statistics will not include analytes that were not detected in greater than 50% of samples. | Day 1, 8, 15, 29 |
| Changes in Concentration of Blood Parameters From Day 1 to Day 15 (Factor VII) | Blood samples are collected and tested for analysis of the levels of cytokines using Luminex-based chemistry to assess for immunology screening and safety monitoring of liver function, renal function, and electrolytes and glucose. | Day 1 - 15 |
| Changes in Concentration of Blood Parameters From Day 1 to Day 15 (ICAM-1) | Blood samples are collected and tested for analysis of the levels of cytokines using Luminex-based chemistry to assess for immunology screening and safety monitoring of liver function, renal function and electrolytes and glucose. | Day 1 - 15 |
| Lost to Follow-up |
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| BG002 | Cohort 3 (4.5 g Dose of Complex Oligosaccharide + Probiotic) | Day 1-7: Subjects receive standard probiotic dose (mixed in aqueous diluent) orally once daily in combination with 4.5 g dose of complex oligosaccharide orally twice daily Day 8-14:Subjects receive only 4.5 g dose of complex oligosaccharide orally twice daily |
| BG003 | Cohort 4 (9 g Dose of Complex Oligosaccharide + Probiotic) | Day 1-7: Subjects receive standard probiotic dose (mixed in aqueous diluent) orally once daily in combination with 9 g dose of complex oligosaccharide orally twice daily Day 8-14:Subjects receive only 9 g dose of complex oligosaccharide orally twice daily |
| BG004 | Cohort 5 (18 g Dose of Complex Oligosaccharide + PPI + Probiotic +/- H2 Blocker) | First Course Day 1-7: Subjects receive standard probiotic dose (mixed in aqueous diluent) and PPI orally once daily in combination with 18 g dose of complex oligosaccharide orally twice daily Day 8-14: Subjects receive only 18 g dose of complex oligosaccharide orally twice daily Second Course Day 29-35: Subjects receive standard probiotic dose (mixed in aqueous diluent) and may receive H2 blocker* orally once daily in combination with 18 g dose of complex oligosaccharide orally twice daily Day 36-42: Subjects receive only 18 g dose of complex oligosaccharide orally twice daily *4 subjects received H2 blocker, 4 subjects did not receive H2 blocker during second course |
| BG005 | Cohort 6 (18 g Dose of Complex Oligosaccharide + Probiotic) | Day 1-7: Subjects receive standard probiotic dose (mixed in aqueous diluent) orally once daily in combination with 18 g dose of complex oligosaccharide orally twice daily Day 8-14: Subjects receive only 18 g dose of complex oligosaccharide orally twice daily |
| BG006 | Total | Total of all reporting groups |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Hemoglobin | Mean | Standard Deviation | g/dL |
|
Day 1-14: Subjects receive 18 g dose of complex oligosaccharide orally twice daily Complex oligosaccharide: Complex oligosaccharide concentrate |
| OG002 | Cohort 3 (4.5 g Dose of Complex Oligosaccharide + Probiotic) | Day 1-7: Subjects receive standard probiotic dose (mixed in aqueous diluent) orally once daily in combination with 4.5 g dose of complex oligosaccharide orally twice daily Day 8-14: Subjects receive only 4.5 g dose of complex oligosaccharide orally twice daily Complex oligosaccharide: Complex oligosaccharide concentrate Probiotic: Probiotic |
| OG003 | Cohort 4 (9 g Dose of Complex Oligosaccharide + Probiotic) | Day 1-7: Subjects receive standard probiotic dose (mixed in aqueous diluent) orally once daily in combination with 9 g dose of complex oligosaccharide orally twice daily Day 8-14:Subjects receive only 9 g dose of complex oligosaccharide orally twice daily |
| OG004 | Cohort 5 (18 g Dose of Complex Oligosaccharide + PPI + Probiotic +/- H2 Blocker) | First Course Day 1-7: Subjects receive standard probiotic dose (mixed in aqueous diluent) and PPI orally once daily in combination with 18 g dose of complex oligosaccharide orally twice daily Day 8-14: Subjects receive only 18 g dose of complex oligosaccharide orally twice daily Second Course Day 29-35: Subjects receive standard probiotic dose (mixed in aqueous diluent) and may receive H2 blocker* orally once daily in combination with 18 g dose of complex oligosaccharide orally twice daily Day 36-42: Subjects receive only 18 g dose of complex oligosaccharide orally twice daily *4 subjects received H2 blocker, 4 subjects did not receive H2 blocker during second course Complex oligosaccharide: Complex oligosaccharide concentrate Probiotic: Probiotic PPI: Over-the-counter proton pump inhibitor (PPI) H2 Blocker: Over-the-counter H2 blocker |
| OG005 | Cohort 6 (18 g Dose of Complex Oligosaccharide + Probiotic) | Day 1-7: Subjects receive standard probiotic dose (mixed in aqueous diluent) orally once daily in combination with 18 g dose of complex oligosaccharide orally twice daily Day 8-14: Subjects receive only 18 g dose of complex oligosaccharide orally twice daily |
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| Secondary | Changes in Concentration of Blood Parameters From Day 1 to Day 15 | Blood samples are collected and tested for analysis of the levels of cytokines using Luminex-based chemistry to assess for immunology screening and safety monitoring of liver function, renal function, and electrolytes and glucose. | Descriptive statistics will not include analytes that were not detected in samples or not detected at high enough concentrations to be above the lower limit of quantification. Values for analytes below the lower limit of quantification were imputed with that value for inclusion in the descriptive statistics. Measurements were only taken for Cohorts 1, 2 and 6. | Posted | Mean | Standard Deviation | pg/mL | Day 1 - 15 |
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| Secondary | Summary of the Evaluation of the Use of Proton Pump Inhibitors for Protection of B. Infantis Levels in Cohorts 5 and 6 by Visit | Evaluation of B. infantis levels in Dose Group 5 will be compared to B. infantis levels in Dose Groups 6 using descriptive statistics including geometric means and 95% confidence intervals of the genome copy number per nanogram of DNA (B. infantis copies/ng DNA). | Microbiome Population (Two cohorts received 18g of HMO with B. infantis and will be distinguished from each other by one receiving the proton pump inhibitor omeprazole. In addition, the cohort dosed with omeprazole received a second round of dosing with half of the subjects receiving famotidine in addition to B. infantis and 18g of HMO and the remainder not receiving any acid reducing drugs) | Posted | Geometric Mean | 95% Confidence Interval | B. infantis (copies/ng DNA) | Day 1, 5, 8, 15, 22, 29, 33, 43, 50, 57 |
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| Secondary | Concentrations (µmol/g) of Lactic Acid in Stool Samples From Day 1 to Day 29 | Descriptive statistics including means and standard deviation of lactate (Cohort 1; 0g HMO + B. infantis, Cohort 2; 18 g HMO, engrafted subjects and not engrafted subjects from Cohorts 5 & 6 combined; 18g HMO + B. infantis). Descriptive statistics will not include analytes that were not detected in greater than 50% of samples. | Cohort 1 (no HMO, only B. infantis), Cohort 2 (18g HMO, no B. infantis). Cohorts 5 and 6 were combined because both of these groups received 18g HMO +B. infantis and this was pre-specified in the analysis plan for this outcome. The measurement of lactic acid was expected, therefore, to be very similar between these two groups and the goal of this analysis was to compare the combination of a probiotic with complex oligosaccharides to each of these separately (Cohorts 1 and 2, respectively). | Posted | Mean | Standard Deviation | µmol/g | Day 1, 8, 15, 29 |
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| Secondary | Changes in Concentration of Blood Parameters From Day 1 to Day 15 (Factor VII) | Blood samples are collected and tested for analysis of the levels of cytokines using Luminex-based chemistry to assess for immunology screening and safety monitoring of liver function, renal function, and electrolytes and glucose. | Descriptive statistics will not include analytes that were not detected in samples or not detected at high enough concentrations to be above the lower limit of quantitation. Values for analytes below the lower limit of quantification were imputed with that value for inclusion in the descriptive statistics. Data were only available for Cohorts 1, 2 and 6. | Posted | Mean | Standard Deviation | ug/mL | Day 1 - 15 |
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| Secondary | Changes in Concentration of Blood Parameters From Day 1 to Day 15 (ICAM-1) | Blood samples are collected and tested for analysis of the levels of cytokines using Luminex-based chemistry to assess for immunology screening and safety monitoring of liver function, renal function and electrolytes and glucose. | Descriptive statistics will not include analytes that were not detected in samples or not detected at high enough concentrations to be above the lower limit of quantification. Values for analytes below the lower limit of quantification were imputed with that value for inclusion in the descriptive statistics. Data were only available for Cohorts 1, 2 and 6. | Posted | Mean | Standard Deviation | ng/mL | Day 1 - 15 |
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| 0 |
| 10 |
| 0 |
| 10 |
| 1 |
| 10 |
| EG001 | Cohort 2 (Complex Oligosaccharide) | Day 1-14: Subjects receive 18 g dose of complex oligosaccharide orally twice daily | 0 | 10 | 0 | 10 | 1 | 10 |
| EG002 | Cohort 3 (4.5 g Dose of Complex Oligosaccharide + Probiotic) | Day 1-7: Subjects receive standard probiotic dose (mixed in aqueous diluent) orally once daily in combination with 4.5 g dose of complex oligosaccharide orally twice daily Day 8-14:Subjects receive only 4.5 g dose of complex oligosaccharide orally twice daily | 0 | 10 | 0 | 10 | 2 | 10 |
| EG003 | Cohort 4 (9 g Dose of Complex Oligosaccharide + Probiotic) | Day 1-7: Subjects receive standard probiotic dose (mixed in aqueous diluent) orally once daily in combination with 9 g dose of complex oligosaccharide orally twice daily Day 8-14:Subjects receive only 9 g dose of complex oligosaccharide orally twice daily | 0 | 10 | 0 | 10 | 1 | 10 |
| EG004 | Cohort 5 (18 g Dose of Complex Oligosaccharide + PPI + Probiotic +/- H2 Blocker) | First Course Day 1-7: Subjects receive standard probiotic dose (mixed in aqueous diluent) and PPI orally once daily in combination with 18 g dose of complex oligosaccharide orally twice daily Day 8-14: Subjects receive only 18 g dose of complex oligosaccharide orally twice daily Second Course Day 29-35: Subjects receive standard probiotic dose (mixed in aqueous diluent) and may receive H2 blocker* orally once daily in combination with 18 g dose of complex oligosaccharide orally twice daily Day 36-42: Subjects receive only 18 g dose of complex oligosaccharide orally twice daily *4 subjects received H2 blocker, 4 subjects did not receive H2 blocker during second course | 0 | 12 | 0 | 12 | 2 | 12 |
| EG005 | Cohort 6 (18 g Dose of Complex Oligosaccharide + Probiotic) | Day 1-7: Subjects receive standard probiotic dose (mixed in aqueous diluent) orally once daily in combination with 18 g dose of complex oligosaccharide orally twice daily Day 8-14: Subjects receive only 18 g dose of complex oligosaccharide orally twice daily | 0 | 10 | 0 | 10 | 4 | 10 |
| Constipation | Gastrointestinal disorders | Systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | Systematic Assessment |
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| Toothache | Gastrointestinal disorders | Systematic Assessment |
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| Vomitting | Gastrointestinal disorders | Systematic Assessment |
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| Decreased appetite | General disorders | Systematic Assessment |
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| Cubital Tunnel Syndrome | Nervous system disorders | Systematic Assessment |
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| Abdominal Distension | Gastrointestinal disorders | Systematic Assessment |
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| Abdominal Pain Upper | Gastrointestinal disorders | Systematic Assessment |
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| D019602 |
| Food and Beverages |
| D006633 | Histamine Antagonists |
| D018494 | Histamine Agents |
| D018377 | Neurotransmitter Agents |
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D045505 | Physiological Effects of Drugs |
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| Brain-Derived Neurotrophic Factor (BDNF) - Study Day 15 |
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| Eotaxin-2 - Study Day 1 |
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| Eotaxin-2 - Study Day 15 |
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| Interleukin-1 beta (IL-1 beta) - Study Day 1 |
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| Interleukin-1 beta (IL-1 beta) - Study Day 15 |
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| Interleukin-1 receptor antagonist (IL-1ra) - Study Day 1 |
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| Interleukin-1 receptor antagonist (IL-1ra) - Study Day 15 |
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| Interleukin-12 Subunit p40 (IL-12p40) - Study Day 1 |
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| Interleukin-12 Subunit p40 (IL-12p40) - Study Day 15 |
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| Interleukin-18 (IL-18) - Study Day 1 |
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| Interleukin-18 (IL-18) - Study Day 15 |
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| Latency-Associated Peptide of Transforming Growth Factor beta 1 (LAP TGF-b1) - Study Day 1 |
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| Latency-Associated Peptide of Transforming Growth Factor beta 1 (LAP TGF-b1) - Study Day 15 |
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| Macrophage Inflammatory Protein-1 beta (MIP-1 beta) - Study Day 1 |
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| Macrophage Inflammatory Protein-1 beta (MIP-1 beta) - Study Day 15 |
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| Vascular Endothelial Growth Factor (VEGF) - Study Day 1 |
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| Vascular Endothelial Growth Factor (VEGF) - Study Day 15 |
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| Day 5 |
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| Day 8 |
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| Day 15 |
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| Day 22 |
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| Day 29 |
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| Day 33 |
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| Day 36 |
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| Day 43 |
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| Day 50 |
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| Day 57 |
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| Lactic acid - Day 8 |
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| Lactic acid - Day 15 |
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| Lactic acid - Day 29 |
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