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

NCT05816291 | Completed

• 1 other identifier: IRB-22-60
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Lactate Blood Increase; Exhaustion - Physiological

Keywords

Blood Lactate; Physiological Exhaustion; Exercise

Outcome Measures

Primary Outcomes (2)

• Aerobic Exercise Performance

  Time to Exhaustion treadmill running at 100% VO2peak

  2 weeks

• Blood lactate response to intense exercise

  Blood lactate response to treadmill running at 100% VO2peak protocol til exhaustion

  2 weeks

Secondary Outcomes (28)

• Alpha and beta diversity of veillonella atypica (fecal samples)

  2 weeks

• Changes in blood Hemoglobin concentration

  2 weeks

• Changes in blood hematocrit

  2 weeks

• Changes in red blood cell count

  2 weeks

• Changes in red blood cell distribution width

  2 weeks

Other Outcomes (4)

• Changes in Resting Heart Rate

  2 weeks

• Changes in Systolic Blood Pressure

  2 weeks

• Changes in Diastolic Blood Pressure

  2 weeks

Study Arms (2)

Placebo

PLACEBO COMPARATOR

14 days of supplementation placebo (maltodextrin)

Dietary Supplement: Time to Exhaustion at velocity at VO2max

Veillonella atypica FB004

EXPERIMENTAL

14 days of supplementation 1 x 109CFU dose Veillonella atypica FB004

Dietary Supplement: Time to Exhaustion at velocity at VO2max

Interventions

Time to Exhaustion at velocity at VO2max DIETARY_SUPPLEMENT

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.

Also known as: TTW

Placebo; Veillonella atypica FB004

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Lindenwood University: lead
• Increnovo, LLC: collaborator

Study Sites (1)

Exercise and Performance Nutrition Laboratory

Saint Charles, Missouri, 63301, United States

Location

MeSH Terms

Conditions

Hyperlactatemia; Motor Activity

Condition Hierarchy (Ancestors)

Metabolic Diseases; Nutritional and Metabolic Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: The same number of capsules will be provided to each participant. Each capsule will be identical in color, shape, smell, and transparency. Participants will be instructed to consume their assigned dose with 8 - 12 fluid ounces of cool water.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 14, 2023
• First Posted: April 18, 2023
• Study Start: March 30, 2022
• Primary Completion: July 26, 2022
• Study Completion: July 26, 2022
• Last Updated: April 18, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)