CompletedNCT05816291VPUpdated Apr 18, 2023

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

An interventional study of Time to Exhaustion at velocity at VO2max in Lactate Blood Increase and Exhaustion - Physiological, sponsored by Lindenwood University. Completed at 1 site in United States. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-04-18.

Sponsored by Lindenwood University · Not applicable, Interventional, and Treatment

From the registry’s dates

Registered 11 months after the study started (first participant enrolled Mar 2022, registered Mar 2023).

Phase: Not applicable
Study type: Interventional
Enrollment: 7
Allocation: Randomized
Ages: 18 Years to 50 Years
Sex: All

Study summary

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 studied

Lactate Blood Increase
Exhaustion - Physiological

Browse trials for

Keywords

Blood Lactate
Physiological Exhaustion
Exercise

In context

Hyperlactatemia

50 studies on the registry are indexed under Hyperlactatemia; 7 are open to participants now.

This study's enrollment of 7 is below the median of 38 across 32 interventional studies indexed under Hyperlactatemia.

Browse Hyperlactatemia studies →

Lead sponsor

Lindenwood University is the lead sponsor of 29 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 50 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Provide voluntary signed and dated .
Be in good health as determined by medical history and routine blood chemistries.
Age between 18 and 50
Exercises > 150 mins/week
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

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 .
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.

Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Study design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover assignment
Masking: Double (Participant, Investigator)
Enrollment: 7 participants (actual)

Study arms

Placebo comparator
Placebo
14 days of supplementation placebo (maltodextrin)
Dietary Supplement: Time to Exhaustion at velocity at VO2max
Experimental
Veillonella atypica FB004
14 days of supplementation 1 x 109CFU dose Veillonella atypica FB004
Dietary Supplement: Time to Exhaustion at velocity at VO2max

Interventions

Dietary supplementTime 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.
Also known as: TTW

What researchers measure

Primary outcomes

Aerobic Exercise Performance
Time to Exhaustion treadmill running at 100% VO2peak
Time frame: 2 weeks
Blood lactate response to intense exercise
Blood lactate response to treadmill running at 100% VO2peak protocol til exhaustion
Time frame: 2 weeks

Secondary outcomes

Alpha and beta diversity of veillonella atypica (fecal samples)
Alpha and beta diversity of veillonella atypica (fecal samples)
Time frame: 2 weeks
Changes in blood Hemoglobin concentration
Complete Blood Count (CBC) with Differential includes: Changes in blood Hemoglobin concentration
Time frame: 2 weeks
Changes in blood hematocrit
Complete Blood Count (CBC) with Differential includes: Changes in blood hematocrit
Time frame: 2 weeks
Changes in red blood cell count
Complete Blood Count (CBC) with Differential includes: Changes in red blood cell count
Time frame: 2 weeks
Changes in red blood cell distribution width
Complete Blood Count (CBC) with Differential includes: Changes in red blood cell distribution width
Time frame: 2 weeks
Changes in mean corpuscular volume (MCV)
Complete Blood Count (CBC) with Differential includes: Changes in mean corpuscular volume (MCV)
Time frame: 2 weeks
Changes in mean corpuscular hemoglobin concentration (MCHC)
Complete Blood Count (CBC) with Differential includes: Changes in mean corpuscular hemoglobin concentration (MCHC)
Time frame: 2 weeks
Changes in mean corpuscular hemoglobin (MCH)
Complete Blood Count (CBC) with Differential includes: Changes in mean corpuscular hemoglobin (MCH)
Time frame: 2 weeks
Changes in white blood cell count
Complete Blood Count (CBC) with Differential includes: Changes in white blood cell count
Time frame: 2 weeks
Changes in platelet count
Complete Blood Count (CBC) with Differential includes: Changes in platelet count
Time frame: 2 weeks
Changes in basophils
Complete Blood Count (CBC) with Differential includes: Changes in basophils
Time frame: 2 weeks
Changes in eosinophils
Complete Blood Count (CBC) with Differential includes: Changes in eosinophils
Time frame: 2 weeks
Changes in neutrophils
Complete Blood Count (CBC) with Differential includes: Changes in neutrophils
Time frame: 2 weeks
Changes in blood Glucose Concentration
Comprehensive metabolic Panel (CMP) includes: Changes in blood glucose Concentration
Time frame: 2 weeks
Changes in blood Sodium Concentration
Comprehensive metabolic Panel (CMP) includes: Changes in blood Sodium Concentration
Time frame: 2 weeks
Changes in blood Potassium Concentration
Comprehensive metabolic Panel (CMP) includes: Changes in blood Potassium Concentration
Time frame: 2 weeks
Changes in blood Chloride Concentration
Comprehensive metabolic Panel (CMP) includes: Changes in blood Chloride Concentration
Time frame: 2 weeks
Changes in blood Carbon Dioxide Concentration
Comprehensive metabolic Panel (CMP) includes: Changes in blood Carbon Dioxide Concentration
Time frame: 2 weeks
Changes in blood Calcium Concentration
Comprehensive metabolic Panel (CMP) includes: Changes in blood Calcium Concentration
Time frame: 2 weeks
Changes in blood alkaline phosphate Concentration
Comprehensive metabolic Panel (CMP) includes: Changes in blood alkaline phosphate Concentration
Time frame: 2 weeks
Changes in blood creatinine Concentration
Comprehensive metabolic Panel (CMP) includes: Changes in blood creatinine Concentration
Time frame: 2 weeks
Changes in blood Bilirubin Concentration
Comprehensive metabolic Panel (CMP) includes: Changes in blood Bilirubin Concentration
Time frame: 2 weeks
Changes in blood Blood Urea Nitrogen (BUN) Concentration
Comprehensive metabolic Panel (CMP) includes: Changes in blood Blood Urea Nitrogen (BUN) Concentration
Time frame: 2 weeks
Changes in blood Albumin Concentration
Comprehensive metabolic Panel (CMP) includes: Changes in blood Albumin Concentration
Time frame: 2 weeks
Changes in blood Globulin Concentration
Comprehensive metabolic Panel (CMP) includes: Changes in blood Globulin Concentration
Time frame: 2 weeks
Changes in blood total protein Concentration
Comprehensive metabolic Panel (CMP) includes: Changes in blood total protein Concentration
Time frame: 2 weeks
Changes in blood Aspartate aminotransferase (AST) Concentration
Comprehensive metabolic Panel (CMP) includes: Changes in blood Aspartate aminotransferase (AST) Concentration
Time frame: 2 weeks
Changes in blood Alanine Aminotransferase (ALT) Concentration
Comprehensive metabolic Panel (CMP) includes: Changes in blood Alanine Aminotransferase (ALT) Concentration
Time frame: 2 weeks

Other outcomes

Changes in Resting Heart Rate
Resting Heart Rate (beats per minute)
Time frame: 2 weeks
Changes in Systolic Blood Pressure
Changes in systolic blood pressure (mmHg)
Time frame: 2 weeks
Changes in Diastolic Blood Pressure
Changes in diastolic blood pressure (mmHg)
Time frame: 2 weeks
Occurrences of Reported adverse events
Occurrences of Reported adverse events
Time frame: 2 weeks

Study locations

1 site

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

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

Timeline

Tracking since Sep 25, 2026

ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Mar 2022 to primary completion in Jul 2022, 3 months.

Of 17 interventional studies with no phase under Hyperlactatemia, half reached primary completion within 8 months of starting (the median), counting those still running; a quarter within 3 and three quarters within 12. This study's 3 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered: Mar 14, 2023
First posted: Apr 18, 2023
StartActual: Mar 30, 2022
Primary completionActual: Jul 26, 2022
CompletionActual: Jul 26, 2022
Last update: Apr 18, 2023

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Apr 18, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT05816291
Lead sponsor: Lindenwood University
Collaborators: Increnovo, LLC
Responsible party: Sponsor
First posted: Apr 18, 2023
Start date: Mar 30, 2022
Primary completion: Jul 26, 2022
Completion: Jul 26, 2022
Last update: Apr 18, 2023

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Hyperlactatemia →

Other studies from this sponsor

Lindenwood University

Start the discussion