Dietary counselling to reduce moderate sodium intake: effects on cardiovascular and renal biomarkers: primary findings of the COSIP and STICK phase II feasibility randomised controlled trials
Bibliographic record
Abstract
Background: While low sodium intake (<2.3 g/day) is recommended, there is uncertainty about long-term feasibility and effects on cardiorenal biomarkers in populations with moderate intake. Methods: In two phase IIb, feasibility, randomised, parallel, open-label, controlled, single-centre trials, individuals aged >40 years with stable blood pressure (BP), without heart failure or postural hypotension were randomised to intensive dietary counselling (target sodium intake <2.3 g/day) or usual care between March 2016 and July 2018. One trial included participants with chronic kidney disease (CKD); the other excluded those with CKD or cardiovascular disease. All participants received healthy eating advice. Primary outcomes were NT-pro B-type natriuretic peptide (NT-proBNP), high sensitivity troponin T (hsTnT), C-reactive protein (CRP), renin, aldosterone and, creatinine clearance (CrCl) at 2-years. These trials are registered with ClinicalTrials.gov, STICK trial (NCT02458248) and COSIP trial (NCT02738736). Findings: 373 participants, with mean 24-h urine sodium 3.16 ± 1.47 g/day, were randomised to intervention (n = 187) or usual care (n = 186). At 3-months, the intervention reduced 24-h urine sodium (intervention -0.11 g/day, usual care +0.28 g/day, p = 0.003), BP (systolic -2.52 mmHg, p = 0.05; diastolic -1.92, p = 0.02) and increased renin (+33.35 mIU/L [95%CI 3.78-62.91]). At 2-years, the intervention significantly reduced self-reported salt use (p < 0.001), but not 24-h urine sodium (intervention -0.23 g/day, usual care +0.05 g/day, p = 0.47). At 2-years, there were no significant between-group differences in BP (systolic p = 0.66; diastolic p = 0.09), NT-proBNP (p = 0.68), hsTnT (p = 0.20), CRP (p = 0.56), renin (p = 0.52), aldosterone (p = 0.61), or CrCl (p = 0.68). Interpretation: Among individuals with moderate sodium intake, intensive dietary counselling resulted in small short-term reductions in sodium intake and BP, but no significant effect on sodium intake, BP, or cardiorenal biomarkers at two years. Our trial suggests that it may not feasible to reduce sodium sustainably in those with a sodium intake around 3.0 g/day, through an intensive dietary counselling intervention. Funding: The STICK trial was funded by the Health Research Board of Ireland and the COSIP trial was funded by the European Research Council.
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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 | 0.009 | 0.014 |
| Meta-epidemiology (narrow) | 0.002 | 0.001 |
| Meta-epidemiology (broad) | 0.005 | 0.005 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.001 | 0.002 |
| Scholarly communication | 0.002 | 0.002 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.004 | 0.003 |
| Insufficient payload (model declined to judge) | 0.011 | 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".