Pilot Study to Examine the Acute Impact of Veillonella Supplementation on Exercise and Lactate Responses
- Conditions
- Lactate Blood IncreaseExhaustion - Physiological
- Interventions
- Dietary Supplement: Time to Exhaustion at velocity at VO2max
- Registration Number
- NCT05816291
- Lead Sponsor
- Lindenwood University
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 7
- 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.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Veillonella atypica FB004 Time to Exhaustion at velocity at VO2max 14 days of supplementation 1 x 109CFU dose Veillonella atypica FB004 Placebo Time to Exhaustion at velocity at VO2max 14 days of supplementation placebo (maltodextrin)
- Primary Outcome Measures
Name Time Method Aerobic Exercise Performance 2 weeks Time to Exhaustion treadmill running at 100% VO2peak
Blood lactate response to intense exercise 2 weeks Blood lactate response to treadmill running at 100% VO2peak protocol til exhaustion
- Secondary Outcome Measures
Name Time Method Changes in blood creatinine Concentration 2 weeks Comprehensive metabolic Panel (CMP) includes: Changes in blood creatinine Concentration
Changes in red blood cell count 2 weeks Complete Blood Count (CBC) with Differential includes: Changes in red blood cell count
Alpha and beta diversity of veillonella atypica (fecal samples) 2 weeks Alpha and beta diversity of veillonella atypica (fecal samples)
Changes in blood Calcium Concentration 2 weeks Comprehensive metabolic Panel (CMP) includes: Changes in blood Calcium Concentration
Changes in blood total protein Concentration 2 weeks Comprehensive metabolic Panel (CMP) includes: Changes in blood total protein Concentration
Changes in blood Aspartate aminotransferase (AST) Concentration 2 weeks Comprehensive metabolic Panel (CMP) includes: Changes in blood Aspartate aminotransferase (AST) Concentration
Changes in blood Alanine Aminotransferase (ALT) Concentration 2 weeks Comprehensive metabolic Panel (CMP) includes: Changes in blood Alanine Aminotransferase (ALT) Concentration
Changes in blood Hemoglobin concentration 2 weeks Complete Blood Count (CBC) with Differential includes: Changes in blood Hemoglobin concentration
Changes in blood hematocrit 2 weeks Complete Blood Count (CBC) with Differential includes: Changes in blood hematocrit
Changes in blood Chloride Concentration 2 weeks Comprehensive metabolic Panel (CMP) includes: Changes in blood Chloride Concentration
Changes in blood Carbon Dioxide Concentration 2 weeks Comprehensive metabolic Panel (CMP) includes: Changes in blood Carbon Dioxide Concentration
Changes in red blood cell distribution width 2 weeks Complete Blood Count (CBC) with Differential includes: Changes in red blood cell distribution width
Changes in mean corpuscular hemoglobin concentration (MCHC) 2 weeks Complete Blood Count (CBC) with Differential includes: Changes in mean corpuscular hemoglobin concentration (MCHC)
Changes in white blood cell count 2 weeks Complete Blood Count (CBC) with Differential includes: Changes in white blood cell count
Changes in basophils 2 weeks Complete Blood Count (CBC) with Differential includes: Changes in basophils
Changes in blood Bilirubin Concentration 2 weeks Comprehensive metabolic Panel (CMP) includes: Changes in blood Bilirubin Concentration
Changes in mean corpuscular hemoglobin (MCH) 2 weeks Complete Blood Count (CBC) with Differential includes: Changes in mean corpuscular hemoglobin (MCH)
Changes in platelet count 2 weeks Complete Blood Count (CBC) with Differential includes: Changes in platelet count
Changes in eosinophils 2 weeks Complete Blood Count (CBC) with Differential includes: Changes in eosinophils
Changes in blood Sodium Concentration 2 weeks Comprehensive metabolic Panel (CMP) includes: Changes in blood Sodium Concentration
Changes in blood Potassium Concentration 2 weeks Comprehensive metabolic Panel (CMP) includes: Changes in blood Potassium Concentration
Changes in blood Blood Urea Nitrogen (BUN) Concentration 2 weeks Comprehensive metabolic Panel (CMP) includes: Changes in blood Blood Urea Nitrogen (BUN) Concentration
Changes in blood Albumin Concentration 2 weeks Comprehensive metabolic Panel (CMP) includes: Changes in blood Albumin Concentration
Changes in mean corpuscular volume (MCV) 2 weeks Complete Blood Count (CBC) with Differential includes: Changes in mean corpuscular volume (MCV)
Changes in neutrophils 2 weeks Complete Blood Count (CBC) with Differential includes: Changes in neutrophils
Changes in blood Glucose Concentration 2 weeks Comprehensive metabolic Panel (CMP) includes: Changes in blood glucose Concentration
Changes in blood alkaline phosphate Concentration 2 weeks Comprehensive metabolic Panel (CMP) includes: Changes in blood alkaline phosphate Concentration
Changes in blood Globulin Concentration 2 weeks Comprehensive metabolic Panel (CMP) includes: Changes in blood Globulin Concentration
Trial Locations
- Locations (1)
Exercise and Performance Nutrition Laboratory
🇺🇸Saint Charles, Missouri, United States