A Study of the Next-generation Probiotic, Veillonella Atypica FB0054 vs Placebo
- Conditions
- Fatigue
- Registration Number
- NCT06141343
- Lead Sponsor
- FitBiomics, Inc.
- Brief Summary
In this study, the investigators are assessing the ability of Veillonella (Veillonella atypica FB0054) to decrease fatigue and increase energy in a heterogeneous cohort of healthy adults compared to placebo. Study subjects will fill out a baseline health and habit survey followed by daily and weekly surveys over a two week baseline period to understand their baseline habits, fatigue, and energy levels. After this, subjects will take one daily capsule orally of one of two doses of Veillonella or placebo for four weeks, while again filling out both daily and weekly surveys. Finally, there will be a two week washout period with no supplementation but only daily and weekly surveys. At the end of the study, there will be a final experience survey.
- Detailed Description
Veillonella is a novel probiotic that can metabolize lactic acid into propionate, which is an energy source for the body. In previous research, the investigators have shown that Veillonella can improve endurance compared to placebo. In mouse studies, those mice who supplemented with V. atypica ran 13% longer in a run-to-exhaustion test than those mice who were given placebo. Furthermore, in a randomized controlled crossover pilot study, the investigators could show that Veillonella prevented 78.7% of the performance decline observed in the placebo group in a run-to-exhaustion model. The investigators have also conducted experiments that have resulted in this product being deemed Generally Regarded As Safe (GRAS).
Therefore, the investigators believe the Veillonella is safe and likely to provide significant benefits in terms of improved endurance, increased energy, and decreased fatigue. This research study is designed to test that hypothesis. FitBiomics is sponsoring this study to confirm these effects in a broader population. FitBiomics is the first company to develop this type of bacteria as a probiotic, and this will be the largest study testing the safety and efficacy of this probiotic.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 153
- Male or female adults aged 18 - 65 years.
- Willing and able to provide written informed consent.
- Ability of the participant to comprehend the full nature and purpose of the study including possible risks and side effects.
- Agreement to comply with the protocol and study restrictions.
- Fluent in written and spoken English.
- In good general health as judged by the Investigator based on medical history.
- Willing to maintain daily exercise and diet habits throughout the 8 week study without making major lifestyle changes.
- Ability to use a personal smartphone device and download the Chloe app by People Science
- Currently pregnant, planning to become pregnant, or lactating during the next 12 weeks
- Have a significant acute or chronic coexisting illness, disorder, or condition that contraindicates, in the Principal Investigator's judgment, entry to the study.
- Currently taking immunosuppressive medications.
- Is considered immunosuppressed for any reason.
- Currently taking medications that could impair the integrity of the gut epithelia
- Has symptoms or an illness, disorder, or cognition that impairs the integrity of the gut epithelia.
- Current antibiotic use or planned oral antibiotic use over the course of the study.
- Investigator believes that the participant may be uncooperative and/or noncompliant and should therefore not participate in the study.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in Multi-dimensional Fatigue Inventory Questionnaire 8 weeks The majority of primary endpoints for this study are questions on the survey which consist of rating scales (generally 1-5 or 1-9). Significant differences between groups for these endpoints will be assessed using an independent T test or Mann-Whitney U test depending on the observed distribution of the data. For significant changes over time within the same group, a dependent T test will be used.
Changes in reported physical fatigue 8 weeks The majority of primary endpoints for this study are questions on the survey which consist of rating scales (generally 1-5 or 1-9). Significant differences between groups for these endpoints will be assessed using an independent T test or Mann-Whitney U test depending on the observed distribution of the data. For significant changes over time within the same group, a dependent T test will be used.
Change in mental / emotional fatigue 8 weeks The majority of primary endpoints for this study are questions on the survey which consist of rating scales (generally 1-5 or 1-9). Significant differences between groups for these endpoints will be assessed using an independent T test or Mann-Whitney U test depending on the observed distribution of the data. For significant changes over time within the same group, a dependent T test will be used.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
FitBiomics, Inc.
🇺🇸New York, New York, United States
FitBiomics, Inc.🇺🇸New York, New York, United States