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

April 13, 2023 updated by: Lindenwood University

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

The purpose of this study is to assess the health and performance outcomes associated with supplementation of Veillonella atypica.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
7

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • Saint Charles, Missouri, United States, 63301
        • Exercise and Performance Nutrition Laboratory

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo
14 days of supplementation placebo (maltodextrin)
Dietary supplement: Time to Exhaustion at velocity at VO2max
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.
Other Names:
  • TTW
Experimental: Veillonella atypica FB004
14 days of supplementation 1 x 109CFU dose Veillonella atypica FB004
Dietary supplement: Time to Exhaustion at velocity at VO2max
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.
Other Names:
  • TTW

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Aerobic Exercise Performance
Time Frame: 2 weeks
Time to Exhaustion treadmill running at 100% VO2peak
2 weeks
Blood lactate response to intense exercise
Time Frame: 2 weeks
Blood lactate response to treadmill running at 100% VO2peak protocol til exhaustion
2 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Alpha and beta diversity of veillonella atypica (fecal samples)
Time Frame: 2 weeks
Alpha and beta diversity of veillonella atypica (fecal samples)
2 weeks
Changes in blood Hemoglobin concentration
Time Frame: 2 weeks
Complete Blood Count (CBC) with Differential includes: Changes in blood Hemoglobin concentration
2 weeks
Changes in blood hematocrit
Time Frame: 2 weeks
Complete Blood Count (CBC) with Differential includes: Changes in blood hematocrit
2 weeks
Changes in red blood cell count
Time Frame: 2 weeks
Complete Blood Count (CBC) with Differential includes: Changes in red blood cell count
2 weeks
Changes in red blood cell distribution width
Time Frame: 2 weeks
Complete Blood Count (CBC) with Differential includes: Changes in red blood cell distribution width
2 weeks
Changes in mean corpuscular volume (MCV)
Time Frame: 2 weeks
Complete Blood Count (CBC) with Differential includes: Changes in mean corpuscular volume (MCV)
2 weeks
Changes in mean corpuscular hemoglobin concentration (MCHC)
Time Frame: 2 weeks
Complete Blood Count (CBC) with Differential includes: Changes in mean corpuscular hemoglobin concentration (MCHC)
2 weeks
Changes in mean corpuscular hemoglobin (MCH)
Time Frame: 2 weeks
Complete Blood Count (CBC) with Differential includes: Changes in mean corpuscular hemoglobin (MCH)
2 weeks
Changes in white blood cell count
Time Frame: 2 weeks
Complete Blood Count (CBC) with Differential includes: Changes in white blood cell count
2 weeks
Changes in platelet count
Time Frame: 2 weeks
Complete Blood Count (CBC) with Differential includes: Changes in platelet count
2 weeks
Changes in basophils
Time Frame: 2 weeks
Complete Blood Count (CBC) with Differential includes: Changes in basophils
2 weeks
Changes in eosinophils
Time Frame: 2 weeks
Complete Blood Count (CBC) with Differential includes: Changes in eosinophils
2 weeks
Changes in neutrophils
Time Frame: 2 weeks
Complete Blood Count (CBC) with Differential includes: Changes in neutrophils
2 weeks
Changes in blood Glucose Concentration
Time Frame: 2 weeks
Comprehensive metabolic Panel (CMP) includes: Changes in blood glucose Concentration
2 weeks
Changes in blood Sodium Concentration
Time Frame: 2 weeks
Comprehensive metabolic Panel (CMP) includes: Changes in blood Sodium Concentration
2 weeks
Changes in blood Potassium Concentration
Time Frame: 2 weeks
Comprehensive metabolic Panel (CMP) includes: Changes in blood Potassium Concentration
2 weeks
Changes in blood Chloride Concentration
Time Frame: 2 weeks
Comprehensive metabolic Panel (CMP) includes: Changes in blood Chloride Concentration
2 weeks
Changes in blood Carbon Dioxide Concentration
Time Frame: 2 weeks
Comprehensive metabolic Panel (CMP) includes: Changes in blood Carbon Dioxide Concentration
2 weeks
Changes in blood Calcium Concentration
Time Frame: 2 weeks
Comprehensive metabolic Panel (CMP) includes: Changes in blood Calcium Concentration
2 weeks
Changes in blood alkaline phosphate Concentration
Time Frame: 2 weeks
Comprehensive metabolic Panel (CMP) includes: Changes in blood alkaline phosphate Concentration
2 weeks
Changes in blood creatinine Concentration
Time Frame: 2 weeks
Comprehensive metabolic Panel (CMP) includes: Changes in blood creatinine Concentration
2 weeks
Changes in blood Bilirubin Concentration
Time Frame: 2 weeks
Comprehensive metabolic Panel (CMP) includes: Changes in blood Bilirubin Concentration
2 weeks
Changes in blood Blood Urea Nitrogen (BUN) Concentration
Time Frame: 2 weeks
Comprehensive metabolic Panel (CMP) includes: Changes in blood Blood Urea Nitrogen (BUN) Concentration
2 weeks
Changes in blood Albumin Concentration
Time Frame: 2 weeks
Comprehensive metabolic Panel (CMP) includes: Changes in blood Albumin Concentration
2 weeks
Changes in blood Globulin Concentration
Time Frame: 2 weeks
Comprehensive metabolic Panel (CMP) includes: Changes in blood Globulin Concentration
2 weeks
Changes in blood total protein Concentration
Time Frame: 2 weeks
Comprehensive metabolic Panel (CMP) includes: Changes in blood total protein Concentration
2 weeks
Changes in blood Aspartate aminotransferase (AST) Concentration
Time Frame: 2 weeks
Comprehensive metabolic Panel (CMP) includes: Changes in blood Aspartate aminotransferase (AST) Concentration
2 weeks
Changes in blood Alanine Aminotransferase (ALT) Concentration
Time Frame: 2 weeks
Comprehensive metabolic Panel (CMP) includes: Changes in blood Alanine Aminotransferase (ALT) Concentration
2 weeks

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Changes in Resting Heart Rate
Time Frame: 2 weeks
Resting Heart Rate (beats per minute)
2 weeks
Changes in Systolic Blood Pressure
Time Frame: 2 weeks
Changes in systolic blood pressure (mmHg)
2 weeks
Changes in Diastolic Blood Pressure
Time Frame: 2 weeks
Changes in diastolic blood pressure (mmHg)
2 weeks
Occurrences of Reported adverse events
Time Frame: 2 weeks
Occurrences of Reported adverse events
2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Lindenwood University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Increnovo, LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 30, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 26, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 26, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 14, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 13, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 18, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 18, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 13, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IRB-22-60

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings