Lactate Blood IncreaseVPNCT05816291
Pilot Study to Examine the Acute Impact of Veillonella Supplementation on Exercise and Lactate Responses
A study testing Time to Exhaustion at velocity at VO2max in people with Lactate Blood Increase and Exhaustion - Physiological, run by Lindenwood University at 1 site in United States.
Trial summary
The purpose of this study is to assess the health and performance outcomes associated with supplementation of Veillonella atypica. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Lactate Blood Increase, Exhaustion - Physiological
- What is being tested?
- Time to Exhaustion at velocity at VO2max
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Mar 2022to 26 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 13Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Exercise and Performance Nutrition Laboratory
Saint Charles, Missouri, 63301
About this study
Official title: 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.
Read the 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.
- Conditions
- Lactate Blood Increase, Exhaustion - Physiological
- Being tested
- Time to Exhaustion at velocity at VO2max
- Keywords
- Blood Lactate, Physiological Exhaustion, Exercise
- Medical subject headings
- Hyperlactatemia, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Time to Exhaustion at velocity at VO2maxDietary supplement
Also called TTW
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.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | 14 days of supplementation placebo (maltodextrin) Receives: Dietary Supplement: Time to Exhaustion at velocity at VO2max |
| Veillonella atypica FB004 | Experimental | 14 days of supplementation 1 x 109CFU dose Veillonella atypica FB004 Receives: Dietary Supplement: Time to Exhaustion at velocity at VO2max |
What is being measured
The primary outcome is the main question the study is designed to answer.
Aerobic Exercise Performance
Time to Exhaustion treadmill running at 100% VO2peak
Measured: 2 weeks
Blood lactate response to intense exercise
Blood lactate response to treadmill running at 100% VO2peak protocol til exhaustion
Measured: 2 weeks
Secondary outcomes (28)
Alpha and beta diversity of veillonella atypica (fecal samples)
Alpha and beta diversity of veillonella atypica (fecal samples)
Measured: 2 weeks
Changes in blood Hemoglobin concentration
Complete Blood Count (CBC) with Differential includes: Changes in blood Hemoglobin concentration
Measured: 2 weeks
Changes in blood hematocrit
Complete Blood Count (CBC) with Differential includes: Changes in blood hematocrit
Measured: 2 weeks
Changes in red blood cell count
Complete Blood Count (CBC) with Differential includes: Changes in red blood cell count
Measured: 2 weeks
Changes in red blood cell distribution width
Complete Blood Count (CBC) with Differential includes: Changes in red blood cell distribution width
Measured: 2 weeks
Changes in mean corpuscular volume (MCV)
Complete Blood Count (CBC) with Differential includes: Changes in mean corpuscular volume (MCV)
Measured: 2 weeks
Changes in mean corpuscular hemoglobin concentration (MCHC)
Complete Blood Count (CBC) with Differential includes: Changes in mean corpuscular hemoglobin concentration (MCHC)
Measured: 2 weeks
Changes in mean corpuscular hemoglobin (MCH)
Complete Blood Count (CBC) with Differential includes: Changes in mean corpuscular hemoglobin (MCH)
Measured: 2 weeks
Changes in white blood cell count
Complete Blood Count (CBC) with Differential includes: Changes in white blood cell count
Measured: 2 weeks
Changes in platelet count
Complete Blood Count (CBC) with Differential includes: Changes in platelet count
Measured: 2 weeks
Changes in basophils
Complete Blood Count (CBC) with Differential includes: Changes in basophils
Measured: 2 weeks
Changes in eosinophils
Complete Blood Count (CBC) with Differential includes: Changes in eosinophils
Measured: 2 weeks
Changes in neutrophils
Complete Blood Count (CBC) with Differential includes: Changes in neutrophils
Measured: 2 weeks
Changes in blood Glucose Concentration
Comprehensive metabolic Panel (CMP) includes: Changes in blood glucose Concentration
Measured: 2 weeks
Changes in blood Sodium Concentration
Comprehensive metabolic Panel (CMP) includes: Changes in blood Sodium Concentration
Measured: 2 weeks
Changes in blood Potassium Concentration
Comprehensive metabolic Panel (CMP) includes: Changes in blood Potassium Concentration
Measured: 2 weeks
Changes in blood Chloride Concentration
Comprehensive metabolic Panel (CMP) includes: Changes in blood Chloride Concentration
Measured: 2 weeks
Changes in blood Carbon Dioxide Concentration
Comprehensive metabolic Panel (CMP) includes: Changes in blood Carbon Dioxide Concentration
Measured: 2 weeks
Changes in blood Calcium Concentration
Comprehensive metabolic Panel (CMP) includes: Changes in blood Calcium Concentration
Measured: 2 weeks
Changes in blood alkaline phosphate Concentration
Comprehensive metabolic Panel (CMP) includes: Changes in blood alkaline phosphate Concentration
Measured: 2 weeks
Changes in blood creatinine Concentration
Comprehensive metabolic Panel (CMP) includes: Changes in blood creatinine Concentration
Measured: 2 weeks
Changes in blood Bilirubin Concentration
Comprehensive metabolic Panel (CMP) includes: Changes in blood Bilirubin Concentration
Measured: 2 weeks
Changes in blood Blood Urea Nitrogen (BUN) Concentration
Comprehensive metabolic Panel (CMP) includes: Changes in blood Blood Urea Nitrogen (BUN) Concentration
Measured: 2 weeks
Changes in blood Albumin Concentration
Comprehensive metabolic Panel (CMP) includes: Changes in blood Albumin Concentration
Measured: 2 weeks
Changes in blood Globulin Concentration
Comprehensive metabolic Panel (CMP) includes: Changes in blood Globulin Concentration
Measured: 2 weeks
Changes in blood total protein Concentration
Comprehensive metabolic Panel (CMP) includes: Changes in blood total protein Concentration
Measured: 2 weeks
Changes in blood Aspartate aminotransferase (AST) Concentration
Comprehensive metabolic Panel (CMP) includes: Changes in blood Aspartate aminotransferase (AST) Concentration
Measured: 2 weeks
Changes in blood Alanine Aminotransferase (ALT) Concentration
Comprehensive metabolic Panel (CMP) includes: Changes in blood Alanine Aminotransferase (ALT) Concentration
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2023
- Study start30 Mar 2022
- Primary completion26 Jul 2022
- Study completion26 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lactate Blood IncreaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- 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 blind
- Who is masked
- Participant, Investigator
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lindenwood University
- Sponsor type
- University, hospital or other
- Collaborators
- Increnovo LLC
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05816291
- Sponsor's protocol ID
- IRB-22-60
- Acronym
- VP
- Status last verified
- Apr 2023
- First submitted
- 14 Mar 2023
- Last updated
- 18 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Crossover Pilot to Examine the Acute Impact of Veillonella Supplementation on Exercise and Lactate Responses
- ClinicalTrials.gov ID
- NCT05816291
- Acronym / sponsor ID
- VP / IRB-22-60
- Conditions
- Lactate Blood Increase, Exhaustion - Physiological
- Keywords
- Blood Lactate, Physiological Exhaustion, Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Lindenwood UniversityUniversity, hospital or other
- Collaborators
- Increnovo LLC
- Study start
- 30 Mar 2022 (actual)
- Primary completion
- 26 Jul 2022 (actual)
- Study completion
- 26 Jul 2022 (actual)
- First posted
- 18 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: Time to Exhaustion at velocity at VO2max14 days of supplementation placebo (maltodextrin) |
| Veillonella atypica FB004 | Experimental | Dietary Supplement: Time to Exhaustion at velocity at VO2max14 days of supplementation 1 x 109CFU dose Veillonella atypica FB004 |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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%
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Time to Exhaustion at velocity at VO2maxAlso: TTWDuring 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. | Dietary supplement | Placebo, Veillonella atypica FB004 |
Primary outcome
Aerobic Exercise Performance
Time frame: 2 weeks
Time to Exhaustion treadmill running at 100% VO2peak
Blood lactate response to intense exercise
Time frame: 2 weeks
Blood lactate response to treadmill running at 100% VO2peak protocol til exhaustion
28 secondary outcomes
Alpha and beta diversity of veillonella atypica (fecal samples)
Time frame: 2 weeks
Changes in blood Hemoglobin concentration
Time frame: 2 weeks
Changes in blood hematocrit
Time frame: 2 weeks
Changes in red blood cell count
Time frame: 2 weeks
Changes in red blood cell distribution width
Time frame: 2 weeks
Changes in mean corpuscular volume (MCV)
Time frame: 2 weeks
Changes in mean corpuscular hemoglobin concentration (MCHC)
Time frame: 2 weeks
Changes in mean corpuscular hemoglobin (MCH)
Time frame: 2 weeks
Changes in white blood cell count
Time frame: 2 weeks
Changes in platelet count
Time frame: 2 weeks
Changes in basophils
Time frame: 2 weeks
Changes in eosinophils
Time frame: 2 weeks
Changes in neutrophils
Time frame: 2 weeks
Changes in blood Glucose Concentration
Time frame: 2 weeks
Changes in blood Sodium Concentration
Time frame: 2 weeks
Changes in blood Potassium Concentration
Time frame: 2 weeks
Changes in blood Chloride Concentration
Time frame: 2 weeks
Changes in blood Carbon Dioxide Concentration
Time frame: 2 weeks
Changes in blood Calcium Concentration
Time frame: 2 weeks
Changes in blood alkaline phosphate Concentration
Time frame: 2 weeks
Changes in blood creatinine Concentration
Time frame: 2 weeks
Changes in blood Bilirubin Concentration
Time frame: 2 weeks
Changes in blood Blood Urea Nitrogen (BUN) Concentration
Time frame: 2 weeks
Changes in blood Albumin Concentration
Time frame: 2 weeks
Changes in blood Globulin Concentration
Time frame: 2 weeks
Changes in blood total protein Concentration
Time frame: 2 weeks
Changes in blood Aspartate aminotransferase (AST) Concentration
Time frame: 2 weeks
Changes in blood Alanine Aminotransferase (ALT) Concentration
Time frame: 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Time to Exhaustion at velocity at VO2max in people with Lactate Blood Increase and Exhaustion - Physiological, run by Lindenwood University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Aerobic Exercise Performance (time frame: 2 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2023.