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
Not provided
The purpose of this study is to assess the health and performance outcomes associated with supplementation of Veillonella atypica.
This pilot study will be conducted using a randomized, double-blind, crossover study design. Healthy men and women (n=7) between the ages of 18 - 50 years of age will be recruited for this study. After signing an IRB-approved consent form, participants will have their peak VO2 determined to finalize eligibility. Eligible participants will then practice their first time to exhaustion trial at 100% VO2Peak. Prior to each subsequent study visit, participants will be scheduled at a similar time between the hours of 0600 and 1000 hours and will be asked to observe an overnight fast (food, caffeine, and nicotine) while refraining from any vigorous exercise for at least 24 hours prior to their visit. During visit 2, participants will have their body composition assessed and complete another time to exhaustion familiarization at 100% VO2Peak. Leading up to and during each subsequent study visit (identical to visit 3), participants will collect a stool sample and upon arrival at the laboratory have their body mass measured before having a venous blood sample collected for assessment of complete blood count and comprehensive metabolic panel. After blood collection, participants will complete the standardized warm-up before completing a treadmill time to exhaustion test at 100% VO2Peak. Capillary lactate levels will be assessed before, immediately after, and 5 minutes after completion of the exhaustion trial using a handheld lactate analyzer. From there and in a randomized, double-blind, placebo-controlled, crossover fashion, participants will be assigned for the next 14 days to ingest either a placebo (maltodextrin) or a 1 x 109CFU dose of Veillonella atypica FB004 (VA) (Fitbiomics, Inc. New York). After supplementing for 14 days, participants will complete an identical battery of tests. Participants will then follow a wash-out period for 21 days before returning to the laboratory to complete study visit 5, the pre-supplementation visit to their supplementation period. After completing study visit 5, participants will be instructed to supplement with the alternative supplement for 14 days before returning for a 6th and final study visit. Participants will complete a two-day food and fluid record prior to visit 3, receivea copy of it from study investigators, and be instructed to replicate it prior to each subsequent study visit.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | 14 days of supplementation placebo (maltodextrin) |
|
| Veillonella atypica FB004 | Experimental | 14 days of supplementation 1 x 109CFU dose Veillonella atypica FB004 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Time to Exhaustion at velocity at VO2max | Dietary Supplement | During a familiarization trial prior to supplementation and before and after each supplementation period at the beginning of each study visit, participants will complete a standardized warm-up consisting of walking on a treadmill for 5 minutes, a series of whole-body dynamic movements (high knees, butt kicks, walking lunges, straight-leg marching, etc.), and a self-prescribed period of jogging on the treadmill for no more than ten minutes. The speed on the treadmill will then be set at the velocity upon which 100% VO2Peak was achieved. Participants will be instructed to run at this velocity for as long as they can. No feedback in terms of duration, pacing, etc. will be provided, and participants will be provided verbal encouragement to run for as long as possible. |
| Measure | Description | Time Frame |
|---|---|---|
| Aerobic Exercise Performance | Time to Exhaustion treadmill running at 100% VO2peak | 2 weeks |
| Blood lactate response to intense exercise | Blood lactate response to treadmill running at 100% VO2peak protocol til exhaustion | 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Alpha and beta diversity of veillonella atypica (fecal samples) | Alpha and beta diversity of veillonella atypica (fecal samples) | 2 weeks |
| Changes in blood Hemoglobin concentration | Complete Blood Count (CBC) with Differential includes: Changes in blood Hemoglobin concentration |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Resting Heart Rate | Resting Heart Rate (beats per minute) | 2 weeks |
| Changes in Systolic Blood Pressure | Changes in systolic blood pressure (mmHg) |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Exercise and Performance Nutrition Laboratory | Saint Charles | Missouri | 63301 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D065906 | Hyperlactatemia |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
Subjects will be assigned to ingest one of two supplement conditions in a randomized, double-blind, and crossover fashion. A randomized order of treatments will be generated by random.org.
Not provided
Not provided
The same number of capsules will be provided to each participant. Each capsule will be identical in color, shape, smell, and transparency. Participants will be instructed to consume their assigned dose with 8 - 12 fluid ounces of cool water.
|
|
| 2 weeks |
| Changes in blood hematocrit | Complete Blood Count (CBC) with Differential includes: Changes in blood hematocrit | 2 weeks |
| Changes in red blood cell count | Complete Blood Count (CBC) with Differential includes: Changes in red blood cell count | 2 weeks |
| Changes in red blood cell distribution width | Complete Blood Count (CBC) with Differential includes: Changes in red blood cell distribution width | 2 weeks |
| Changes in mean corpuscular volume (MCV) | Complete Blood Count (CBC) with Differential includes: Changes in mean corpuscular volume (MCV) | 2 weeks |
| Changes in mean corpuscular hemoglobin concentration (MCHC) | Complete Blood Count (CBC) with Differential includes: Changes in mean corpuscular hemoglobin concentration (MCHC) | 2 weeks |
| Changes in mean corpuscular hemoglobin (MCH) | Complete Blood Count (CBC) with Differential includes: Changes in mean corpuscular hemoglobin (MCH) | 2 weeks |
| Changes in white blood cell count | Complete Blood Count (CBC) with Differential includes: Changes in white blood cell count | 2 weeks |
| Changes in platelet count | Complete Blood Count (CBC) with Differential includes: Changes in platelet count | 2 weeks |
| Changes in basophils | Complete Blood Count (CBC) with Differential includes: Changes in basophils | 2 weeks |
| Changes in eosinophils | Complete Blood Count (CBC) with Differential includes: Changes in eosinophils | 2 weeks |
| Changes in neutrophils | Complete Blood Count (CBC) with Differential includes: Changes in neutrophils | 2 weeks |
| Changes in blood Glucose Concentration | Comprehensive metabolic Panel (CMP) includes: Changes in blood glucose Concentration | 2 weeks |
| Changes in blood Sodium Concentration | Comprehensive metabolic Panel (CMP) includes: Changes in blood Sodium Concentration | 2 weeks |
| Changes in blood Potassium Concentration | Comprehensive metabolic Panel (CMP) includes: Changes in blood Potassium Concentration | 2 weeks |
| Changes in blood Chloride Concentration | Comprehensive metabolic Panel (CMP) includes: Changes in blood Chloride Concentration | 2 weeks |
| Changes in blood Carbon Dioxide Concentration | Comprehensive metabolic Panel (CMP) includes: Changes in blood Carbon Dioxide Concentration | 2 weeks |
| Changes in blood Calcium Concentration | Comprehensive metabolic Panel (CMP) includes: Changes in blood Calcium Concentration | 2 weeks |
| Changes in blood alkaline phosphate Concentration | Comprehensive metabolic Panel (CMP) includes: Changes in blood alkaline phosphate Concentration | 2 weeks |
| Changes in blood creatinine Concentration | Comprehensive metabolic Panel (CMP) includes: Changes in blood creatinine Concentration | 2 weeks |
| Changes in blood Bilirubin Concentration | Comprehensive metabolic Panel (CMP) includes: Changes in blood Bilirubin Concentration | 2 weeks |
| Changes in blood Blood Urea Nitrogen (BUN) Concentration | Comprehensive metabolic Panel (CMP) includes: Changes in blood Blood Urea Nitrogen (BUN) Concentration | 2 weeks |
| Changes in blood Albumin Concentration | Comprehensive metabolic Panel (CMP) includes: Changes in blood Albumin Concentration | 2 weeks |
| Changes in blood Globulin Concentration | Comprehensive metabolic Panel (CMP) includes: Changes in blood Globulin Concentration | 2 weeks |
| Changes in blood total protein Concentration | Comprehensive metabolic Panel (CMP) includes: Changes in blood total protein Concentration | 2 weeks |
| Changes in blood Aspartate aminotransferase (AST) Concentration | Comprehensive metabolic Panel (CMP) includes: Changes in blood Aspartate aminotransferase (AST) Concentration | 2 weeks |
| Changes in blood Alanine Aminotransferase (ALT) Concentration | Comprehensive metabolic Panel (CMP) includes: Changes in blood Alanine Aminotransferase (ALT) Concentration | 2 weeks |
| 2 weeks |
| Changes in Diastolic Blood Pressure | Changes in diastolic blood pressure (mmHg) | 2 weeks |
| Occurrences of Reported adverse events | Occurrences of Reported adverse events | 2 weeks |
| D001519 | Behavior |