Summary: In adults with type 2 diabetes, overweight or obesity, and existing eating disorder symptoms judged at high risk (n=56, England), a 12-week low-energy total diet replacement (TDR) programme with remote behavioural support did not worsen eating disorder symptoms versus usual care at 6 months (between-group EDE-Q difference -0.8 points, 95% CI -1.4 to -0.3; pre-specified non-inferiority met). A larger weight loss was observed in the TDR arm at 6 months (between-group difference -10.2 kg, 95% CI -14.2 to -6.2), and no participant developed a new eating disorder.
PICO Summary
| Element | Detail |
|---|---|
| Population | 56 adults with type 2 diabetes, overweight or obesity, and eating disorder symptoms judged at high risk (mean age 49.9 years, mean BMI 39.6 kg/m2, mean EDE-Q global score 3.3); randomised, controlled, non-inferiority trial across England. |
| Intervention | Remotely delivered low-energy TDR programme (n=28): 12 weeks of nutritionally complete formula soups, shakes, and bars, then stepped food reintroduction (~8 weeks) and weight-maintenance support (~4 weeks), with behavioural support. |
| Comparison | Usual care for type 2 diabetes (n=28). |
| Outcome | Primary outcome (change in EDE-Q global score at 6 months): between-group difference -0.8 points (95% CI -1.4 to -0.3), with the upper confidence bound below the pre-specified non-inferiority margin of +0.72 (1 SD), so non-inferiority was met. Weight at 6 months: between-group difference -10.2 kg (95% CI -14.2 to -6.2) favouring TDR. At 12 months weight change did not differ between groups, while EDE-Q non-inferiority (and superiority) persisted. No participant was suspected of having developed a new eating disorder; 13 adverse events occurred, of which one (a cholecystectomy) was serious. No formal hypothesis test was reported for the weight difference in the abstract. |
ARIADNE Trial
RCT · type 2 diabetes · non-inferiority
A supported total diet replacement programme did not worsen eating disorder symptoms (non-inferiority met) and produced greater weight loss at 6 months; no new eating disorders developed.
Expert Commentary
This small non-inferiority trial addresses a clinically important worry: whether a rigid, weight-focused total diet replacement programme might trigger or worsen disordered eating in an already vulnerable group. The verdict from the data is reassuring rather than triumphant. Non-inferiority on the EDE-Q global score was met, no participant was judged to have developed a new eating disorder, and the point estimate even hinted at benefit, while clinically meaningful weight loss was achieved at 6 months. These findings are best read as evidence of safety and feasibility, not as proof that TDR treats eating disorder symptoms. The dominant limitation is statistical fragility: only 56 participants were randomised, the confidence intervals are wide, and the cohort was almost entirely White and drawn from a single country, so generalisability is limited. The programme was necessarily unblinded, since a formula-only diet cannot be masked, and the trial was funded by the Novo Nordisk UK Research Foundation, a manufacturer-linked source that warrants noting even where products were not the intervention. The weight advantage had also disappeared by 12 months. Can I use this with my patients? Cautiously yes, for the narrow question of whether a supervised TDR programme should be withheld purely out of fear of provoking an eating disorder; this evidence suggests that, with behavioural support and monitoring, it need not be. It does not license unsupervised use. Larger, more diverse, independently funded trials with longer follow-up should now confirm whether the suggestion of benefit is real.
References
Tsompanaki E, Aveyard P, Park RJ, Jebb SA, Koutoukidis DA. An intensive weight loss programme with behavioural support for people with type 2 diabetes at risk of eating disorders in England (ARIADNE): a randomised, controlled, non-inferiority trial. Lancet Psychiatry. 2025;12(7):483-492. doi:10.1016/S2215-0366(25)00126-9