Rationale, Design and Baseline Characteristics for the Strategies to Oppose SUGARS With Non-nutritive Sweeteners or Water (STOP Sugars NOW) Trial
Bibliographic record
Abstract
Health authorities recommend reducing added or free sugars to ≤5–10% energy. Much attention has focussed of the reduction of SSBs with the recommendation that SSBs be replaced with unsweetened healthy alternatives such as water but not non-nutritive sweetened beverages (NSBs). There are concerns that non-nutritive sweeteners do not have the intended benefits and may induce glucose intolerance through changes in the gut microbiome. Whether NSBs have benefits similar to water in their intended substitution for SSBs is unclear. To address this question, we have undertaken the STOP Sugars NOW trial (NCT03543644), a pragmatic “head-to-head” crossover randomized controlled trial of the effect of NSBs (the intended substitution) versus water (the standard of care) as a replacement strategy for SSBs on glucose tolerance and gut microbiome diversity. We recruited overweight or obese participants with a high waist circumference who regularly consume ≥1 SSBs/day. Each participant underwent a ≥2-week run-in period followed by three 4- week treatment phases in random order (usual SSBs, equivalent NSBs, or water) with each phase separated by a ≥4-week washout. The two primary outcomes are change in glucose tolerance and gut microbiome beta- diversity. Adherence to the interventions will be assessed by objective biomarkers of added sugars (13C/12C isotopic ratio in serum fatty acids and urinary fructose and sucrose) and non-nutritive sweeteners (urinary sucralose and acesulfame-potassium). The trial started on June 1st, 2018 with the first participant undergoing randomization on August 1st, 2019 and the last participant finishing on October 15th, 2020. We screened 1,086 individuals, out of which 80 were randomized. Baseline characteristics showed a mean age of 41.8 ± 13.0 y, BMI of 33.7 ± 6.8 kg/m2, waist circumference of 108.7 ± 13.5 cm, and mean SSBs intake of 2 SSBs/day. The results of this trial will directly inform public health guidance on the use of NSBs in sugars reduction strategies. CIHR.
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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 | 0.037 | 0.033 |
| Meta-epidemiology (narrow) | 0.005 | 0.003 |
| Meta-epidemiology (broad) | 0.006 | 0.003 |
| Bibliometrics | 0.002 | 0.002 |
| Science and technology studies | 0.003 | 0.004 |
| Scholarly communication | 0.003 | 0.003 |
| Open science | 0.003 | 0.001 |
| Research integrity | 0.005 | 0.006 |
| Insufficient payload (model declined to judge) | 0.047 | 0.013 |
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".