Time-restricted eating versus dietetic guidance on glycaemic outcomes in adults at risk of type 2 diabetes: a non-inferiority randomised clinical trial
Primary result · Change in HbA1cResult — go to the resultMean difference −0.22 mmol/mol 95% CI −0.72 to 0.30Authors' conclusion
TRE may offer a pragmatic and practical short-term alternative when access to dietetic support is limited, or if the approach is preferred by an individual.
Study context
- Population
- Adults at risk of T2D (overweight or obesity and score ≥15 on the Australian T2D risk assessment tool), two Australian clinical research institutes; mean ± SD HbA1c 40 ± 3 mmol/mol (5.8 ± 0.3%)randomised 1:1
- Participants
- 124 vs 123
- Comparison
- Time-restricted eating (TRE) vs individualised dietetic guidance
- TREn = 124
- Individualised dietetic guidance (IDG)n = 123reference
- Primary endpoint
- Between-group difference for change in HbA1c
- Follow-up
- 4 months
Methodological detailstwo-arm, parallel-group, multi-centre, non-inferiority, assessor-blinded, Assessors and analysts blinded; participants and dietitians unblinded
- Two-arm
- Parallel-group
- Multi-centre
- Non-inferiority
- Assessor-blinded
- Assessors and analysts blinded; participants and dietitians unblinded
Primary result
Change in HbA1c
Mean difference
−0.22 mmol/mol
95% CI −0.72 to 0.30
P = 0.40
TREvs IDG
mean difference −0.22 mmol/mol (95% CI −0.72 to 0.30); P = 0.40
Non-inferiority margin 1.1 as printed, not drawn
As reported in the abstract
Secondary outcomes
| Outcome | Mean difference (mmol/mol) (95% CI) | P value | |
|---|---|---|---|
| Change in HbA1c · 12 months0.05 [−0.02, 0.11]% | 0.47 (−0.19 to 1.23) | P = 0.14 | |
| −0.500.511.5Difference, mmol/mol (linear scale) |
Change in HbA1c · 12 months
- Upper bound exceeded non-inferiority margin (0.10%); non-inferiority could no longer be concluded
- Absolute changes in HbA1c small and not clinically meaningful in either group at either time point
Safety
Adverse events · 12 months
- Adverse events were minor and not different between interventions
Original publication
Time-restricted eating versus dietetic guidance on glycaemic outcomes in adults at risk of type 2 diabetes: a non-inferiority randomised clinical trial. Diabetologia. Published 6 June 2026. doi:10.
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