Pilot Study to Examine the Acute Impact of Veillonella Supplementation on Exercise and Lactate Responses
Condition: Lactate Blood Increase; Exhaustion - Physiological
MeSH terms: Hyperlactatemia
Study type: Interventional

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.
    

Intervention name(s): Time to Exhaustion at velocity at VO2max
Intervention type(s): Dietary Supplement
Intervention description(s): 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.
Other intervention name(s): TTW
Allocation: Randomized
Intervention model: Crossover Assignment
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.
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Blood Lactate; Physiological Exhaustion; Exercise