A Study of the Next-generation Probiotic, Veillonella Atypica FB0054 vs Placebo
Condition: Fatigue
MeSH terms: Fatigue
Study type: Observational

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.
    

Intervention name(s): Veillonella atypica FB0054; Placebo
Intervention type(s): Dietary Supplement; Other
Intervention description(s): Veillonella contains Veillonella atypica FB0054 as the active ingredient with microcrystalline cellulose and hypromellose as excipients. The two doses are 15 billion cfu (high dose) and 7.5 billion cfu (low dose). Placebo capsules contain microcrystalline cellulose and hypromellose. Both Veillonella and placebo are encapsulated in acid-resistant capsules to improve delivery to the large intestine, which participants will take orally at home on a daily basis for four weeks.; Placebo will be given as the non-active study control
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Participants in this study will be healthy adults interested in using Veillonella to reduce
        fatigue and increase energy. Subjects will be excluded from the study if they have
        conditions, diseases, or medications that could result in increased likelihood of AEs
        related to Veillonella use.