Time-restricted eating versus dietetic guidance on glycaemic outcomes in adults at risk of type 2 diabetes: a non-inferiority randomised clinical trial
Parr EB, Charrouf R, Hutchison AT, Flint SA, Teong XT, Vincent AD, Bravo-Garcia AP, Siviour Z, Wittert GA, Brennan L, Devlin BL, Hawley JA, Heilbronn LK
Diabetologia · 1 cita
Cómo se estudió
- Diseño
- Ensayo controlado aleatorizado (indexado por PubMed)
- Estudiado en
- Personas
- Resultado principal
- Marcadores de salud y funcionamiento
Quién lo pagó
- Financiación
- Financiación independiente
- Gobierno
- Australian Government
- Organización sin fines de lucro
- European Association for the Study of Diabetes
- Universidad u hospital
- Adelaide University
- Gobierno
- Australian Government Medical Research Future Fund
Según 4 financiadores declarados y la declaración de financiación del texto completo.
Publicación
- Publicado
- 2026-06-06 · Diabetologia · vol. 69 · número 9 · págs. 2458–2471
- Editorial
- Springer Science+Business Media
- Citado
- 2 citas · más que el 97% de estudios similares · 8.1× el promedio de su campo
- Impacto
- Entre el 10 % más citado de su campo
- Referencias
- 48 trabajos
- Acceso
- Acceso abierto (revista híbrida) · CC-BY
- Áreas de investigación
- Dietary Effects on Health · Diet and metabolism studies · Diabetes Management and Research
- Palabras clave
- time-restricted eating, type 2 diabetes prevention, HbA1c, glycemic control, non-inferiority, overweight and obesity, insulin resistance, nocturnal glucose, cardiometabolic outcomes, body composition, non-pharmacological treatment
- MeSH
- humans, diabetes mellitus, type 2, blood glucose, fasting, dietetics, energy intake, adult, aged, middle aged, female, male, glycated hemoglobin, intermittent fasting
13 autores
- Evelyn B. Parr🇦🇺Australian Catholic University
- Rasha Charrouf🇦🇺South Australian Health and Medical Research Institute; Adelaide University; The University of Adelaide
- Amy T. Hutchison🇦🇺South Australian Health and Medical Research Institute; Adelaide University; The University of Adelaide
- Steve A. Flint🇦🇺The University of Melbourne; Australian Catholic University
- Xiao Tong Teong🇦🇺South Australian Health and Medical Research Institute; Adelaide University; The University of Adelaide
- Andrew D. Vincent🇦🇺South Australian Health and Medical Research Institute; Adelaide University; The University of Adelaide
- Ana Paula Bravo-García🇦🇺Australian Catholic University
- Zoe Siviour🇦🇺Australian Catholic University
- Gary Wittert🇦🇺South Australian Health and Medical Research Institute; Adelaide University; The University of Adelaide
- Leah Brennan🇦🇺La Trobe University
- Brooke L. Devlin🇦🇺The University of Queensland
- John Alan Hawley🇬🇧🇦🇺 · autor de correspondenciaManchester Metropolitan University; Australian Catholic University
- Leonie Kaye Heilbronn🇦🇺 · autor de correspondenciaSouth Australian Health and Medical Research Institute; Adelaide University; The University of Adelaide
Resumen
El texto original del estudio, en el idioma en que se publicó.
Aims/hypothesis
Time-restricted eating (TRE) consolidates daily energy intake to a consistent 6-10 h window. The aim was to assess whether TRE is non-inferior to individualised dietetic guidance (IDG) in changing HbA1c at 4 months in adults at risk of type 2 diabetes.
Methods
In a two-arm, parallel-group, multi-centre randomised, non-inferiority clinical trial at two Australian clinical research institutes, adults at risk of type 2 diabetes (i.e. with overweight or obesity and a score of ≥15 on the Australian type 2 diabetes risk assessment tool) were recruited. Participants were randomly assigned using an electronic system (1:1) to TRE (9 h, self-selected eating window, last eating occasion by 19:00 hours) or IDG. Staff conducting assessments and analyses were blinded to allocation; participants and dietitians were unblinded. Both groups received five personalised telehealth consultations between 0 and 3 months (3 h total), specific to their allocated group. The primary outcome was the between-group difference for change in HbA1c at 4 months assessed via covariate linear regression using multiple imputation with a non-inferiority margin set at 1.1 mmol/mol (0.10%). Secondary outcomes were change in HbA1c at 12 months and changes in fasting glucose, insulin, HOMA-IR and nocturnal glucose AUC. Exploratory outcomes included changes in cardiometabolic outcomes and body mass and composition. Adverse events were tracked for 12 months.
Results
One hundred and twenty four participants were randomised to TRE and 123 to IDG (mean ± SD HbA1c: 40 ± 3 mmol/mol [5.8 ± 0.3%]). At 4 months, TRE was non-inferior but not superior to IDG for HbA1c (mean [95% CI]: -0.22 [-0.72, 0.30] mmol/mol; -0.02 [-0.07, 0.03]%; p=0.40). At 12 months, the upper bound of the difference between groups was larger than the non-inferiority margin (0.10%) meaning that non-inferiority could no longer be concluded (mean [95% CI]: 0.47 [-0.19, 1.23] mmol/mol; 0.05 [-0.02, 0.11]%; p=0.14). However, the absolute changes in HbA1c were small and not clinically meaningful in either group at either time point. Adverse events were minor and not different between interventions.
Conclusions/interpretation
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.
Trial registration
ClinicalTrials.gov; NCT04762251 FUNDING: This research was funded by the Australian Government Medical Research Future Fund (MRFF 1200555).
Resumen vía Europe PMC. Los derechos de autor siguen siendo de los autores o la editorial (CC BY).
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