Safety assessment and gastrointestinal tolerance of a novel highly bioavailable turmeric extract formulation: A randomised, double-blind, placebo controlled clinical trial
Bibliographic record
Abstract
Recent advances have led the development of turmeric formulations providing notable blood levels of curcuminoids following ingestion. However, there is a lack of clinical trials confirming the tolerability and safety of these formulations after repeated consumption by healthy subjects, as previous studies have primarily focused on efficacy and safety in subjects with health conditions. This randomised controlled trial assessed the gastrointestinal tolerance and safety of a novel turmeric extract formulation (TF) in healthy adults. Sixty subjects were assigned to either the TF group, receiving 1000 mg or placebo group (maltodextrin), once daily for 5 weeks. The study evaluated: gastrointestinal tolerance [including bloating, abdominal cramping, stomach noises, flatulence, frequency and consistency of stools and perception of Gastrointestinal Quality of Life (GIQLI)], a comprehensive analysis of haematology, clinical biochemistry and urinalysis parameters, vital signs, and a record of adverse events (AEs). No statistically significant differences were observed in gastrointestinal tolerance between the groups. Clinical parameters were not adversely affected by TF consumption, and the incidence and severity of AEs were similar in both groups. In conclusion, daily oral consumption of 1000 mg TF, thus exceeding the recommended 300 mg dose, was well tolerated and safe in healthy adults over the 5-week period.
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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 | 0.003 | 0.002 |
| Meta-epidemiology (narrow) | 0.001 | 0.001 |
| Meta-epidemiology (broad) | 0.003 | 0.001 |
| Bibliometrics | 0.001 | 0.000 |
| Science and technology studies | 0.001 | 0.001 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.000 |
| Research integrity | 0.002 | 0.002 |
| Insufficient payload (model declined to judge) | 0.005 | 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".