Pilot Study to Examine the Acute Impact of Veillonella NCT05816291

Clinical Trial Details — Status: Completed

Administrative data
NCT number	NCT05816291
Other study ID #	IRB-22-60
Secondary ID
Status	Completed
Phase	N/A
First received
Last updated
Start date	March 30, 2022
Est. completion date	July 26, 2022

Study information
Verified date	April 2023
Source	Lindenwood University
Contact	n/a
Is FDA regulated	No
Health authority
Study type	Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status	Completed
Enrollment	7
Est. completion date	July 26, 2022
Est. primary completion date	July 26, 2022
Accepts healthy volunteers	Accepts Healthy Volunteers
Gender	All
Age group	18 Years to 50 Years
Eligibility	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.

Related Conditions & MeSH terms

Intervention

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.

Locations
Country	Name	City	State
United States	Exercise and Performance Nutrition Laboratory	Saint Charles	Missouri

Sponsors *(2)*
Lead Sponsor	Collaborator
Lindenwood University	Increnovo, LLC

Country where clinical trial is conducted

United States,

See also
Status	Clinical Trial	Phase
Recruiting	`NCT05108467` - Saving Lives by Early Detection and Treatment of Sepsis and Septic Shock by Point of Care Lactate Test in Adults
Completed	`NCT04641104` - The Thiamine Administration After Cardiac Surgery Trial	Phase 4
Not yet recruiting	`NCT03115970` - Feasibility of Lactate Level Evaluation in Prehospital Care in Trauma	N/A
Recruiting	`NCT03831685` - Blood Lactate Level for Pre-hospital Orientation of Septic Shock
Completed	`NCT03974906` - Goal-directed Fluid Therapy in Elderly Patients Undergoing Lumbar Surgery	N/A
Not yet recruiting	`NCT03980678` - Lithothamnion Species on Blood Lactate During Exhaustive Exercise in Trained Cyclists	N/A
Completed	`NCT05611398` - Lactate Monitoring in Traumatic Long Bone Fractures Requiring Emergent Surgical Intervention
Completed	`NCT04777747` - The Role of Lactate in Viral and Bacterial Infection
Recruiting	`NCT03062683` - Serum Lactate in Convulsive Syncopes Compared to Non-convulsive Syncopes	N/A
Completed	`NCT05295836` - Effects of Acute Glycerol Ingestion on Performance, Metabolic and Biochemical Markers in International Athletes	N/A
Completed	`NCT06292910` - Central Venous to Arterial CO2 Difference and Low Cardiac Output Syndrome Related Outcomes in Children After Cardiac Surgery
Active, not recruiting	`NCT04796285` - A Validation Study of the Lab Clasp Device: A Point of Care Sepsis Risk Monitor	N/A

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

Clinical Trial Details — Status: Completed

Administrative data

Study information

Clinical Trial Summary

Description:

Recruitment information / eligibility

Study Design

Related Conditions & MeSH terms

Intervention

Locations

Sponsors (2)

Country where clinical trial is conducted

Outcome

Type	Measure	Description	Time frame
Other	Changes in Resting Heart Rate	Resting Heart Rate (beats per minute)	2 weeks
Other	Changes in Systolic Blood Pressure	Changes in systolic blood pressure (mmHg)	2 weeks
Other	Changes in Diastolic Blood Pressure	Changes in diastolic blood pressure (mmHg)	2 weeks
Other	Occurrences of Reported adverse events	Occurrences of Reported adverse events	2 weeks
Primary	Aerobic Exercise Performance	Time to Exhaustion treadmill running at 100% VO2peak	2 weeks
Primary	Blood lactate response to intense exercise	Blood lactate response to treadmill running at 100% VO2peak protocol til exhaustion	2 weeks
Secondary	Alpha and beta diversity of veillonella atypica (fecal samples)	Alpha and beta diversity of veillonella atypica (fecal samples)	2 weeks
Secondary	Changes in blood Hemoglobin concentration	Complete Blood Count (CBC) with Differential includes: Changes in blood Hemoglobin concentration	2 weeks
Secondary	Changes in blood hematocrit	Complete Blood Count (CBC) with Differential includes: Changes in blood hematocrit	2 weeks
Secondary	Changes in red blood cell count	Complete Blood Count (CBC) with Differential includes: Changes in red blood cell count	2 weeks
Secondary	Changes in red blood cell distribution width	Complete Blood Count (CBC) with Differential includes: Changes in red blood cell distribution width	2 weeks
Secondary	Changes in mean corpuscular volume (MCV)	Complete Blood Count (CBC) with Differential includes: Changes in mean corpuscular volume (MCV)	2 weeks
Secondary	Changes in mean corpuscular hemoglobin concentration (MCHC)	Complete Blood Count (CBC) with Differential includes: Changes in mean corpuscular hemoglobin concentration (MCHC)	2 weeks
Secondary	Changes in mean corpuscular hemoglobin (MCH)	Complete Blood Count (CBC) with Differential includes: Changes in mean corpuscular hemoglobin (MCH)	2 weeks
Secondary	Changes in white blood cell count	Complete Blood Count (CBC) with Differential includes: Changes in white blood cell count	2 weeks
Secondary	Changes in platelet count	Complete Blood Count (CBC) with Differential includes: Changes in platelet count	2 weeks
Secondary	Changes in basophils	Complete Blood Count (CBC) with Differential includes: Changes in basophils	2 weeks
Secondary	Changes in eosinophils	Complete Blood Count (CBC) with Differential includes: Changes in eosinophils	2 weeks
Secondary	Changes in neutrophils	Complete Blood Count (CBC) with Differential includes: Changes in neutrophils	2 weeks
Secondary	Changes in blood Glucose Concentration	Comprehensive metabolic Panel (CMP) includes: Changes in blood glucose Concentration	2 weeks
Secondary	Changes in blood Sodium Concentration	Comprehensive metabolic Panel (CMP) includes: Changes in blood Sodium Concentration	2 weeks
Secondary	Changes in blood Potassium Concentration	Comprehensive metabolic Panel (CMP) includes: Changes in blood Potassium Concentration	2 weeks
Secondary	Changes in blood Chloride Concentration	Comprehensive metabolic Panel (CMP) includes: Changes in blood Chloride Concentration	2 weeks
Secondary	Changes in blood Carbon Dioxide Concentration	Comprehensive metabolic Panel (CMP) includes: Changes in blood Carbon Dioxide Concentration	2 weeks
Secondary	Changes in blood Calcium Concentration	Comprehensive metabolic Panel (CMP) includes: Changes in blood Calcium Concentration	2 weeks
Secondary	Changes in blood alkaline phosphate Concentration	Comprehensive metabolic Panel (CMP) includes: Changes in blood alkaline phosphate Concentration	2 weeks
Secondary	Changes in blood creatinine Concentration	Comprehensive metabolic Panel (CMP) includes: Changes in blood creatinine Concentration	2 weeks
Secondary	Changes in blood Bilirubin Concentration	Comprehensive metabolic Panel (CMP) includes: Changes in blood Bilirubin Concentration	2 weeks
Secondary	Changes in blood Blood Urea Nitrogen (BUN) Concentration	Comprehensive metabolic Panel (CMP) includes: Changes in blood Blood Urea Nitrogen (BUN) Concentration	2 weeks
Secondary	Changes in blood Albumin Concentration	Comprehensive metabolic Panel (CMP) includes: Changes in blood Albumin Concentration	2 weeks
Secondary	Changes in blood Globulin Concentration	Comprehensive metabolic Panel (CMP) includes: Changes in blood Globulin Concentration	2 weeks
Secondary	Changes in blood total protein Concentration	Comprehensive metabolic Panel (CMP) includes: Changes in blood total protein Concentration	2 weeks
Secondary	Changes in blood Aspartate aminotransferase (AST) Concentration	Comprehensive metabolic Panel (CMP) includes: Changes in blood Aspartate aminotransferase (AST) Concentration	2 weeks
Secondary	Changes in blood Alanine Aminotransferase (ALT) Concentration	Comprehensive metabolic Panel (CMP) includes: Changes in blood Alanine Aminotransferase (ALT) Concentration	2 weeks