Clinical trial NCT05816291: Pilot Study to Examine the Acute Impact of Veillonella Supplementation on Exercise and Lactate Responses
Official title: A Randomized, Crossover Pilot to Examine the Acute Impact of Veillonella Supplementation on Exercise and Lactate Responses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lactate Blood Increase
Exhaustion - Physiological
Keywords: Blood Lactate
Physiological Exhaustion
Exercise
Lead sponsor: Lindenwood University
Sponsor class: OTHER
Collaborators: name: Increnovo, LLC
First posted: 2023-04-18
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention 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.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Aerobic Exercise Performance
timeFrame: 2 weeks
measure: Blood lactate response to intense exercise
timeFrame: 2 weeks
Secondary outcomes:
measure: Alpha and beta diversity of veillonella atypica (fecal samples)
timeFrame: 2 weeks
measure: Changes in blood Hemoglobin concentration
timeFrame: 2 weeks
measure: Changes in blood hematocrit
timeFrame: 2 weeks
measure: Changes in red blood cell count
timeFrame: 2 weeks
measure: Changes in red blood cell distribution width
timeFrame: 2 weeks
measure: Changes in mean corpuscular volume (MCV)
timeFrame: 2 weeks
measure: Changes in mean corpuscular hemoglobin concentration (MCHC)
timeFrame: 2 weeks
measure: Changes in mean corpuscular hemoglobin (MCH)
timeFrame: 2 weeks
measure: Changes in white blood cell count
timeFrame: 2 weeks
measure: Changes in platelet count
timeFrame: 2 weeks
measure: Changes in basophils
timeFrame: 2 weeks
measure: Changes in eosinophils
timeFrame: 2 weeks
measure: Changes in neutrophils
timeFrame: 2 weeks
measure: Changes in blood Glucose Concentration
timeFrame: 2 weeks
measure: Changes in blood Sodium Concentration
timeFrame: 2 weeks
measure: Changes in blood Potassium Concentration
timeFrame: 2 weeks
measure: Changes in blood Chloride Concentration
timeFrame: 2 weeks
measure: Changes in blood Carbon Dioxide Concentration
timeFrame: 2 weeks
measure: Changes in blood Calcium Concentration
timeFrame: 2 weeks
measure: Changes in blood alkaline phosphate Concentration
timeFrame: 2 weeks
measure: Changes in blood creatinine Concentration
timeFrame: 2 weeks
measure: Changes in blood Bilirubin Concentration
timeFrame: 2 weeks
measure: Changes in blood Blood Urea Nitrogen (BUN) Concentration
timeFrame: 2 weeks
measure: Changes in blood Albumin Concentration
timeFrame: 2 weeks
measure: Changes in blood Globulin Concentration
timeFrame: 2 weeks
measure: Changes in blood total protein Concentration
timeFrame: 2 weeks
measure: Changes in blood Aspartate aminotransferase (AST) Concentration
timeFrame: 2 weeks
measure: Changes in blood Alanine Aminotransferase (ALT) Concentration
timeFrame: 2 weeks
Other outcomes:
measure: Changes in Resting Heart Rate
timeFrame: 2 weeks
measure: Changes in Systolic Blood Pressure
timeFrame: 2 weeks
measure: Changes in Diastolic Blood Pressure
timeFrame: 2 weeks
measure: Occurrences of Reported adverse events
timeFrame: 2 weeks
Locations:
city: Saint Charles
country: United States
facility: Exercise and Performance Nutrition Laboratory
state: Missouri
Study officials:
References: