Effects of one month of intermittent fasting on the blood microbiome in healthy volunteers (OMIF): A randomized controlled crossover study protocol
Bibliographic record
Abstract
BACKGROUND: It is hypothesized that the presence of microorganisms in the gut is reflected in circulating blood through small DNA fragments resulting from the degradation of these organisms. Cross-sectional studies have not yet provided a definitive answer regarding the validity of this hypothesis, and the potential presence of a so-called common blood-microbiome remains highly controversial. Both bioinformatical pipelines (which may produce false-positive results) and environmental contamination may obscure the less than 5 % microbial DNA that is postulated to be present within the total blood DNA. METHOD/DESIGN: This study aims to validate the existence of the blood microbiome using one month of intermittent fasting (OMIF). Through a prospective, randomized, controlled cross-over trial, we will evaluate the effect of OMIF on the composition and function of the blood microbiome in healthy volunteers, with secondary outcomes on clarifying the relationship between the gut and blood microbiome. Healthy volunteers aged 18-65 will be enrolled. All volunteers will undergo OMIF, a washout period and an ad libitum diet for another month, with the order of the interventions assigned randomly. We will assess the dynamics in blood microbiome in response to OMIF versus those seen during an ad libitum diet, using shotgun sequencing. Physiological changes will be monitored A dietary recall interview will be conducted during the trial to evaluate energy intake, and movement data collected from Health App will be used to assess changes in physical activity. CONCLUSION: If successful, this trial provides a proof-of-concept study documenting the existence of a bona fide blood microbiome. CLINICAL TRIAL REGISTRATION: NCT06678516.
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How this classification was reachedexpand
Full frame distilled prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.
Codex and Gemma teacher scores by category
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.067 | 0.123 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.011 | 0.002 |
| Bibliometrics | 0.000 | 0.001 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.001 |
| Insufficient payload (model declined to judge) | 0.000 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; both teacher heads agree on what is shown here.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".