Examining the Feasibility of Prolonged Beta-Hydroxybutyrate-Containing Supplement Drink Consumption in Adults with Type 2 Diabetes: A Randomized Controlled Pilot Trial
Bibliographic record
Abstract
Objectives To conduct a double-blind, remote, randomized, placebo-controlled pilot trial to determine the feasibility of repeated and prolonged beta-hydroxybutyrate (BHB)-containing supplement ingestion in free-living adults with type 2 diabetes (T2D).Methods Individuals living with T2D (N = 40) were randomized to 90 days of thrice daily BHB-containing supplement ingestion (ketone; 5 g of R-β-hydroxybutyric acid with 5 g of R-1,3-butanediol; i.e., 3 × 10g of daily ketone servings) or a taste-matched calorie-free placebo. Feasibility was defined based on a priori specified criteria using recruitment rate, drop-out rate, compliance, gastrointestinal (GI) symptomatology, and data availability. Exploratory efficacy analyses were conducted for clinical outcome measures.Results Most feasibility criteria were met, except there was a relatively high drop-out rate in the ketone (8 participants, 40%) compared to the placebo (2 participants, 10%) group, mostly related to GI symptoms and unpleasant supplement taste. Including completers and data from drop-outs up to the point of withdrawal, compliance was similar in both groups, with 17 ± 4 and 18 ± 4 drinks/week (out of a possible 21) consumed in the ketone and placebo groups, respectively. Drink acceptability appeared similar between groups; however, participants in the ketone group required greater effort to consume the drinks over time. Drink acceptability was negatively correlated to GI symptoms (r= −0.656; p = 0.001), suggesting greater potential for supplement use in individuals experiencing fewer GI symptoms. Despite higher drop-out, ketone supplementation appeared to have both acute and chronic glucose-lowering effects based on continuous glucose monitoring metrics.Conclusion This remote pilot trial demonstrated mixed feasibility results. Recruitment, trial procedures, and data availability were strong but there was relatively high drop-out in the ketone group due to GI issues and taste. However, individuals who tolerated the supplement had good compliance over 90 days and there appeared to be evidence for glucose-lowering efficacy.
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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 | 0.005 | 0.003 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.002 | 0.000 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.000 |
| 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; a candidate call from one teacher head, 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".