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| Name | Class |
|---|---|
| People Science, Inc. | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Veillonella atypica FB0054 | Active ingredient dietary supplement group |
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| Placebo | No active ingredient |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Veillonella atypica FB0054 | Dietary Supplement | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in reported physical fatigue | 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. | 8 weeks |
| Change in mental / emotional fatigue | 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. | 8 weeks |
| Change in Multi-dimensional Fatigue Inventory Questionnaire | 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. | 8 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Jonathan Scheiman, PhD | FitBiomics, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| FitBiomics, Inc. | New York | New York | 10014 | United States |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 16, 2023 | Aug 3, 2023 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 14, 2023 | Aug 3, 2023 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D005221 | Fatigue |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Placebo | Other | Placebo will be given as the non-active study control |
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