Low-Energy Total Diet Replacement Does Not Worsen Eating Disorder Symptoms in High-Risk Patients: Lancet

Low-calorie TDR diets, usually formula products of nutritionally complete fare like soups, shakes, and bars, are most frequently employed for inducing fast weight loss in those with obesity. Their strict composition and emphasis on weight loss have, however, fueled worry over their capacity to induce disordered eating, particularly in susceptible individuals. That fear was addressed by this trial in a rigorous assessment of the safety and psychological effects of TDR in a high-risk group.

The trial was a randomized, controlled, non-inferiority trial in England involving participants with type 2 diabetes, overweight, and exhibiting signs of eating disorder symptoms. Participants were allocated (1:1) to a low-energy TDR program or standard care for diabetes.

Intervention comprised:

• 12 weeks of low-energy diet with formula products

• 8 weeks of stepped reintroduction of foods

• 4 weeks of weight maintenance advice tailored to participants' preferences

Behavioral treatment was provided remotely. The main outcome was modification in the Eating Disorder Examination Questionnaire (EDE-Q) global score at 6 months. Safety was measured by tracking the development of any new cases of eating disorder. The non-inferiority bound was +1 SD (0.72) for the EDE-Q score.

Participant Profile

• From March 8 to September 12, 2023, 56 participants were enrolled altogether

• 28 in intervention group and 28 in control group

• Mean age: 49.9 years (SD 8.1)

• Gender: 35 (63%) women, 20 (36%) men, 1 (2%) non-binary

• Ethnicity: 54 (96%) White, 2 (4%) Asian

• Mean BMI: 39.6 kg/m² (SD 7.8)

• Mean baseline EDE-Q score: 3.3 (SD 0.4)

Key Findings

At 6 months, when TDR program concluded:

• Mean weight loss in the intervention group was –13.9 kg (SD 11.2)

• Control group lost –3.7 kg (SD 7.9)

• Between-group difference in weight: –10.2 kg (95% CI: –14.2 to –6.2)

Symptoms of eating disorders improved:

• Between-group difference in EDE-Q global score: –0.8 points (95% CI: –1.4 to –0.3), establishing non-inferiority

• No participant was suspected of having a new eating disorder

• At 12 months, while between-group differences in weight change were no longer statistically significant, EDE-Q score improvement was maintained, suggesting psychological benefit over the long term.

Engagement in a remotely delivered, structured total diet replacement (TDR) program did not exacerbate eating disorder symptoms in individuals with type 2 diabetes and obesity who were at elevated risk for disordered eating. The program resulted in significant weight reduction and even demonstrated evidence of decreasing eating disorder scores. This study justifies the safe implementation of TDR with adjunctive behavioral treatment in clinical practice.

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