Tolerability of Capsaicinoids from<i>Capsicum</i>Extract in a Beadlet Form: A Pilot Study
Bibliographic record
Abstract
A single center, open-label, dose-finding adaptive study was conducted in twelve healthy overweight female subjects. The study was to evaluate the safety and tolerability of the capsaicinoids (CAPs) from Capsicum extract in a beadlet form compared to placebo in a healthy overweight population. The investigational product capsaicinoids (CAPs) from Capsicum extract in a beadlet form (Capsimax®) a proprietary encapsulated form of Capsicum extract in beadlet form supplemented at 2 mg, 4 mg, 6 mg, 8 mg and 10 mg of CAPs. An ascending dose protocol evaluated a total dose of 10 mg daily given in five divided doses (2 mg, 4 mg, 6 mg, 8 mg and 10 mg of CAPs). Each dose was given for a week. Safety and tolerability were assessed. Primary outcomes were tolerability assessments and reports of adverse events. Tolerability assessments were observed on skin color and any changes in skin, bowel movement, digestion, mouth or throat, hair color or changes in hair color, urination includes frequency and burning sensations, breathing, any changes in their health. Secondary outcomes were body weight, body mass index (BMI), blood pressure (SBP/DBP), vital signs, electrocardiograms, clinical chemistry parameters including liver function tests, lung function tests and kidney function tests and complete blood count (CBC). No dose effective changes were observed. The escalating dose levels of CAPs in a beadlet form product found was tolerable and safe for weight management studies. Tolerability assessments and safety blood markers showed no significant changes from baseline. No significant serious adverse events were reported throughout the duration of the study. Further longer term studies are required to explore the tolerability of the product. This trial is registered with ISRCTN: # ISRCTN10975080.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.001 | 0.001 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.001 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.000 | 0.001 |
| Open science | 0.001 | 0.000 |
| Research integrity | 0.001 | 0.001 |
| Insufficient payload (model declined to judge) | 0.003 | 0.001 |
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; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
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".