Pilot Study to Examine the Acute Impact of Veillonella Supplementation on Exercise and Lactate Responses

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the health and performance outcomes associated with supplementation of Veillonella atypica.

Detailed Description
-----------------
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.

Official Title
-----------------
A Randomized, Crossover Pilot to Examine the Acute Impact of Veillonella Supplementation on Exercise and Lactate Responses

Conditions
-----------------
Lactate Blood Increase, Exhaustion - Physiological

Intervention / Treatment
-----------------
* Dietary Supplement: Time to Exhaustion at velocity at VO2max


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Provide voluntary signed and dated informed consent. Be in good health as determined by medical history and routine blood chemistries. Age between 18 and 50 Exercises > 150 mins/week Body Mass Index of 18.5-29.9 and Body Fat of 30% Normotensive (seated, resting systolic blood pressure < 140 mm Hg and diastolic blood pressure < 90 mm Hg. If the first measurement is slightly elevated above these limits, the subject will be given a brief (5 minute) rest period, and two more measurements will be taken. The average of all three measurements will be used to determine eligibility. Normal seated, resting heart rate (< 90 beats per minute). Willing to follow all study protocols. Exclusion Criteria: Individuals currently diagnosed or being treated for any cardiac, respiratory, endocrine, psychiatric, musculoskeletal, renal, hepatic, neuromuscular or metabolic disease or disorder that in the judgement of the study participant's personal physician or research nurse that will preclude their safe participation or will contraindicate quality control over the collected data Individuals currently diagnosed with or are being treated for celiac disease, lactose intolerance, digestive insufficiencies or other gastrointestinal complications such as irritable bowel syndrome, ulcerative colitis, etc. Alcohol consumption (more than 2 standard alcoholic drinks per day or more than 10 drinks per week) or drug abuse or dependence. Smokers or individuals who have quit smoking within the last 6 months Known sensitivity to any ingredient in the test formulations as listed in the Nutrition Facts label. Individuals who are determined to be on a ketogenic diet. Individuals who are cognitively impaired and/or who are unable to give informed consent. Individuals taking a medication known to impact digestive function or hormonal functions that may impact how our body digests, absorbs, or metabolizes nutrients Individuals currently taking a probiotic or a dietary supplement that may impact digestive function or hormonal functions that may impact how our body digests, absorbs, or metabolizes nutrients Pregnant women, women trying to become pregnant, or nursing women. Participants who indicate they are actively restricting calories or attempting to lose weight. Individuals who do not participate in aerobic exercise > 2 days/week Any other condition which in the Investigator's opinion may adversely affect the subject's ability to complete the study or its measures or which may pose a significant risk to the subject.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: 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.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>14 days of supplementation placebo (maltodextrin) | Dietary Supplement: Time to Exhaustion at velocity at VO2max<br>* 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.<br>* Other names: TTW;|
| Experimental: Veillonella atypica FB004<br>14 days of supplementation 1 x 109CFU dose Veillonella atypica FB004 | Dietary Supplement: Time to Exhaustion at velocity at VO2max<br>* 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.<br>* Other names: TTW;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Blood Lactate, Physiological Exhaustion, Exercise