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

Primary Purpose

Lactate Blood Increase, Exhaustion - Physiological

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Time to Exhaustion at velocity at VO2max
Sponsored by
Lindenwood University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lactate Blood Increase focused on measuring Blood Lactate, Physiological Exhaustion, Exercise

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Exercise and Performance Nutrition Laboratory

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

Veillonella atypica FB004

Arm Description

14 days of supplementation placebo (maltodextrin)

14 days of supplementation 1 x 109CFU dose Veillonella atypica FB004

Outcomes

Primary Outcome Measures

Aerobic Exercise Performance
Time to Exhaustion treadmill running at 100% VO2peak
Blood lactate response to intense exercise
Blood lactate response to treadmill running at 100% VO2peak protocol til exhaustion

Secondary Outcome Measures

Alpha and beta diversity of veillonella atypica (fecal samples)
Alpha and beta diversity of veillonella atypica (fecal samples)
Changes in blood Hemoglobin concentration
Complete Blood Count (CBC) with Differential includes: Changes in blood Hemoglobin concentration
Changes in blood hematocrit
Complete Blood Count (CBC) with Differential includes: Changes in blood hematocrit
Changes in red blood cell count
Complete Blood Count (CBC) with Differential includes: Changes in red blood cell count
Changes in red blood cell distribution width
Complete Blood Count (CBC) with Differential includes: Changes in red blood cell distribution width
Changes in mean corpuscular volume (MCV)
Complete Blood Count (CBC) with Differential includes: Changes in mean corpuscular volume (MCV)
Changes in mean corpuscular hemoglobin concentration (MCHC)
Complete Blood Count (CBC) with Differential includes: Changes in mean corpuscular hemoglobin concentration (MCHC)
Changes in mean corpuscular hemoglobin (MCH)
Complete Blood Count (CBC) with Differential includes: Changes in mean corpuscular hemoglobin (MCH)
Changes in white blood cell count
Complete Blood Count (CBC) with Differential includes: Changes in white blood cell count
Changes in platelet count
Complete Blood Count (CBC) with Differential includes: Changes in platelet count
Changes in basophils
Complete Blood Count (CBC) with Differential includes: Changes in basophils
Changes in eosinophils
Complete Blood Count (CBC) with Differential includes: Changes in eosinophils
Changes in neutrophils
Complete Blood Count (CBC) with Differential includes: Changes in neutrophils
Changes in blood Glucose Concentration
Comprehensive metabolic Panel (CMP) includes: Changes in blood glucose Concentration
Changes in blood Sodium Concentration
Comprehensive metabolic Panel (CMP) includes: Changes in blood Sodium Concentration
Changes in blood Potassium Concentration
Comprehensive metabolic Panel (CMP) includes: Changes in blood Potassium Concentration
Changes in blood Chloride Concentration
Comprehensive metabolic Panel (CMP) includes: Changes in blood Chloride Concentration
Changes in blood Carbon Dioxide Concentration
Comprehensive metabolic Panel (CMP) includes: Changes in blood Carbon Dioxide Concentration
Changes in blood Calcium Concentration
Comprehensive metabolic Panel (CMP) includes: Changes in blood Calcium Concentration
Changes in blood alkaline phosphate Concentration
Comprehensive metabolic Panel (CMP) includes: Changes in blood alkaline phosphate Concentration
Changes in blood creatinine Concentration
Comprehensive metabolic Panel (CMP) includes: Changes in blood creatinine Concentration
Changes in blood Bilirubin Concentration
Comprehensive metabolic Panel (CMP) includes: Changes in blood Bilirubin Concentration
Changes in blood Blood Urea Nitrogen (BUN) Concentration
Comprehensive metabolic Panel (CMP) includes: Changes in blood Blood Urea Nitrogen (BUN) Concentration
Changes in blood Albumin Concentration
Comprehensive metabolic Panel (CMP) includes: Changes in blood Albumin Concentration
Changes in blood Globulin Concentration
Comprehensive metabolic Panel (CMP) includes: Changes in blood Globulin Concentration
Changes in blood total protein Concentration
Comprehensive metabolic Panel (CMP) includes: Changes in blood total protein Concentration
Changes in blood Aspartate aminotransferase (AST) Concentration
Comprehensive metabolic Panel (CMP) includes: Changes in blood Aspartate aminotransferase (AST) Concentration
Changes in blood Alanine Aminotransferase (ALT) Concentration
Comprehensive metabolic Panel (CMP) includes: Changes in blood Alanine Aminotransferase (ALT) Concentration

Full Information

First Posted
March 14, 2023
Last Updated
April 13, 2023
Sponsor
Lindenwood University
Collaborators
Increnovo, LLC
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1. Study Identification

Unique Protocol Identification Number
NCT05816291
Brief Title
Pilot Study to Examine the Acute Impact of Veillonella Supplementation on Exercise and Lactate Responses
Acronym
VP
Official Title
A Randomized, Crossover Pilot to Examine the Acute Impact of Veillonella Supplementation on Exercise and Lactate Responses
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
March 30, 2022 (Actual)
Primary Completion Date
July 26, 2022 (Actual)
Study Completion Date
July 26, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lindenwood University
Collaborators
Increnovo, LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lactate Blood Increase, Exhaustion - Physiological
Keywords
Blood Lactate, Physiological Exhaustion, Exercise

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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
ParticipantInvestigator
Masking Description
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.
Allocation
Randomized
Enrollment
7 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
14 days of supplementation placebo (maltodextrin)
Arm Title
Veillonella atypica FB004
Arm Type
Experimental
Arm Description
14 days of supplementation 1 x 109CFU dose Veillonella atypica FB004
Intervention Type
Dietary Supplement
Intervention Name(s)
Time to Exhaustion at velocity at VO2max
Other Intervention Name(s)
TTW
Intervention Description
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.
Primary Outcome Measure Information:
Title
Aerobic Exercise Performance
Description
Time to Exhaustion treadmill running at 100% VO2peak
Time Frame
2 weeks
Title
Blood lactate response to intense exercise
Description
Blood lactate response to treadmill running at 100% VO2peak protocol til exhaustion
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
Alpha and beta diversity of veillonella atypica (fecal samples)
Description
Alpha and beta diversity of veillonella atypica (fecal samples)
Time Frame
2 weeks
Title
Changes in blood Hemoglobin concentration
Description
Complete Blood Count (CBC) with Differential includes: Changes in blood Hemoglobin concentration
Time Frame
2 weeks
Title
Changes in blood hematocrit
Description
Complete Blood Count (CBC) with Differential includes: Changes in blood hematocrit
Time Frame
2 weeks
Title
Changes in red blood cell count
Description
Complete Blood Count (CBC) with Differential includes: Changes in red blood cell count
Time Frame
2 weeks
Title
Changes in red blood cell distribution width
Description
Complete Blood Count (CBC) with Differential includes: Changes in red blood cell distribution width
Time Frame
2 weeks
Title
Changes in mean corpuscular volume (MCV)
Description
Complete Blood Count (CBC) with Differential includes: Changes in mean corpuscular volume (MCV)
Time Frame
2 weeks
Title
Changes in mean corpuscular hemoglobin concentration (MCHC)
Description
Complete Blood Count (CBC) with Differential includes: Changes in mean corpuscular hemoglobin concentration (MCHC)
Time Frame
2 weeks
Title
Changes in mean corpuscular hemoglobin (MCH)
Description
Complete Blood Count (CBC) with Differential includes: Changes in mean corpuscular hemoglobin (MCH)
Time Frame
2 weeks
Title
Changes in white blood cell count
Description
Complete Blood Count (CBC) with Differential includes: Changes in white blood cell count
Time Frame
2 weeks
Title
Changes in platelet count
Description
Complete Blood Count (CBC) with Differential includes: Changes in platelet count
Time Frame
2 weeks
Title
Changes in basophils
Description
Complete Blood Count (CBC) with Differential includes: Changes in basophils
Time Frame
2 weeks
Title
Changes in eosinophils
Description
Complete Blood Count (CBC) with Differential includes: Changes in eosinophils
Time Frame
2 weeks
Title
Changes in neutrophils
Description
Complete Blood Count (CBC) with Differential includes: Changes in neutrophils
Time Frame
2 weeks
Title
Changes in blood Glucose Concentration
Description
Comprehensive metabolic Panel (CMP) includes: Changes in blood glucose Concentration
Time Frame
2 weeks
Title
Changes in blood Sodium Concentration
Description
Comprehensive metabolic Panel (CMP) includes: Changes in blood Sodium Concentration
Time Frame
2 weeks
Title
Changes in blood Potassium Concentration
Description
Comprehensive metabolic Panel (CMP) includes: Changes in blood Potassium Concentration
Time Frame
2 weeks
Title
Changes in blood Chloride Concentration
Description
Comprehensive metabolic Panel (CMP) includes: Changes in blood Chloride Concentration
Time Frame
2 weeks
Title
Changes in blood Carbon Dioxide Concentration
Description
Comprehensive metabolic Panel (CMP) includes: Changes in blood Carbon Dioxide Concentration
Time Frame
2 weeks
Title
Changes in blood Calcium Concentration
Description
Comprehensive metabolic Panel (CMP) includes: Changes in blood Calcium Concentration
Time Frame
2 weeks
Title
Changes in blood alkaline phosphate Concentration
Description
Comprehensive metabolic Panel (CMP) includes: Changes in blood alkaline phosphate Concentration
Time Frame
2 weeks
Title
Changes in blood creatinine Concentration
Description
Comprehensive metabolic Panel (CMP) includes: Changes in blood creatinine Concentration
Time Frame
2 weeks
Title
Changes in blood Bilirubin Concentration
Description
Comprehensive metabolic Panel (CMP) includes: Changes in blood Bilirubin Concentration
Time Frame
2 weeks
Title
Changes in blood Blood Urea Nitrogen (BUN) Concentration
Description
Comprehensive metabolic Panel (CMP) includes: Changes in blood Blood Urea Nitrogen (BUN) Concentration
Time Frame
2 weeks
Title
Changes in blood Albumin Concentration
Description
Comprehensive metabolic Panel (CMP) includes: Changes in blood Albumin Concentration
Time Frame
2 weeks
Title
Changes in blood Globulin Concentration
Description
Comprehensive metabolic Panel (CMP) includes: Changes in blood Globulin Concentration
Time Frame
2 weeks
Title
Changes in blood total protein Concentration
Description
Comprehensive metabolic Panel (CMP) includes: Changes in blood total protein Concentration
Time Frame
2 weeks
Title
Changes in blood Aspartate aminotransferase (AST) Concentration
Description
Comprehensive metabolic Panel (CMP) includes: Changes in blood Aspartate aminotransferase (AST) Concentration
Time Frame
2 weeks
Title
Changes in blood Alanine Aminotransferase (ALT) Concentration
Description
Comprehensive metabolic Panel (CMP) includes: Changes in blood Alanine Aminotransferase (ALT) Concentration
Time Frame
2 weeks
Other Pre-specified Outcome Measures:
Title
Changes in Resting Heart Rate
Description
Resting Heart Rate (beats per minute)
Time Frame
2 weeks
Title
Changes in Systolic Blood Pressure
Description
Changes in systolic blood pressure (mmHg)
Time Frame
2 weeks
Title
Changes in Diastolic Blood Pressure
Description
Changes in diastolic blood pressure (mmHg)
Time Frame
2 weeks
Title
Occurrences of Reported adverse events
Description
Occurrences of Reported adverse events
Time Frame
2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Facility Information:
Facility Name
Exercise and Performance Nutrition Laboratory
City
Saint Charles
State/Province
Missouri
ZIP/Postal Code
63301
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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