Ignite Creation Date:
2024-05-06 @ 6:53 PM
Last Modification Date:
2024-10-26 @ 2:56 PM
Study NCT ID:
NCT05816291
Status:
COMPLETED
Last Update Posted:
2023-04-18
First Post:
2023-03-14
Brief Title:
Pilot Study to Examine the Acute Impact of Veillonella Supplementation on Exercise and Lactate Responses
Sponsor:
Lindenwood University
Organization:
Lindenwood University
Study Overview
Official Title:
A Randomized Crossover Pilot to Examine the Acute Impact of Veillonella Supplementation on Exercise and Lactate Responses
Status:
COMPLETED
Status Verified Date:
2023-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
VP
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 n7 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None