Financiado en parte por Novo Nordisk, Novo Nordisk Fonden, Novo Nordisk Foundation
Effects of 3 months of 10-h per-day time-restricted eating and 3 months of follow-up on bodyweight and cardiometabolic health in Danish individuals at high risk of type 2 diabetes: the RESET single-centre, parallel, superiority, open-label, randomised controlled trial
Quist JS, Pedersen HE, Jensen MM, Clemmensen KKB, Bjerre N, Ekblond TS, Uldal S, Størling J, Wewer Albrechtsen NJ, Holst JJ, Torekov SS, Nyeland ME, Vistisen D, Jørgensen ME, Panda S, Brock C, Finlayson G, Blond MB, Færch K
The lancet. Healthy longevity · 39 citas
Etiquetas de revisión
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Cómo se estudió
- Diseño
- Ensayo controlado aleatorizado (indexado por PubMed)
- Estudiado en
- Personas
- Resultado principal
- Marcadores de salud y funcionamiento
Quién lo pagó
- Financiación
- Financiado por la industria
- Gobierno
- Innovationsfonden
- Universidad u hospital
- Steno Diabetes Center Copenhagen
- Universidad u hospital
- Aalborg Universitet
- Empresa
- Novo Nordisk
- Organización sin fines de lucro
- Helsefonden
- Empresa
- Novo Nordisk Fonden
- Empresa
- Novo Nordisk Foundation
- Sin clasificar
- Innovation Fund
- Universidad u hospital
- Steno Diabetes Center Copenhagen (SDCC)
- Universidad u hospital
- Aalborg University
- Subvenciones
- Steno Diabetes Center Copenhagen (SDCC 3.F CMP); Novo Nordisk Fonden (NNF23OC0084970); Novo Nordisk Fonden (NNF21SA0072746); Novo Nordisk Fonden (NNF17OC0027822); Novo Nordisk Fonden (NNF20SA0064190)
Según 10 financiadores declarados.
Publicación
- Publicado
- 2024-04-05 · Lancet Healthy Longev · vol. 5 · número 5 · págs. e314–e325
- Editorial
- Elsevier BV
- Citado
- 47 citas · más que el 99% de estudios similares · 11.1× el promedio de su campo
- Impacto
- Entre el 10 % más citado de su campo
- Referencias
- 30 trabajos
- Acceso
- Acceso abierto (revista) · CC-BY-NC-ND
- Áreas de investigación
- Dietary Effects on Health · Diet and metabolism studies · Nutritional Studies and Diet
- Palabras clave
- time-restricted eating, eating window, type 2 diabetes prevention, prediabetes, body weight, cardiometabolic risk factors, insulin sensitivity, insulin resistance, blood pressure, fasting blood glucose, HOMA-IR, cardiometabolic health, obesity, overweight, dietary intervention
- MeSH
- humans, diabetes mellitus, type 2, obesity, body weight, follow-up studies, adult, aged, middle aged, denmark, female, male, overweight
19 autores
- Jonas Salling Quist🇩🇰🇬🇧 · autor de correspondenciaUniversity of Copenhagen; University of Leeds; Copenhagen University Hospital; Steno Diabetes Center Copenhagen
- Hanne Pedersen🇩🇰University of Southern Denmark; Novo Nordisk (Denmark); Copenhagen University Hospital; Steno Diabetes Center Copenhagen
- Marie Møller Jensen🇩🇰Copenhagen University Hospital; Steno Diabetes Center Copenhagen; Aalborg University
- Kim Katrine Bjerring Clemmensen🇩🇰Novo Nordisk (Denmark); Copenhagen University Hospital; Steno Diabetes Center Copenhagen
- Natasja Bjerre🇩🇰University of Copenhagen; Copenhagen University Hospital; Steno Diabetes Center Copenhagen
- Trine Spragge Ekblond🇩🇰Copenhagen University Hospital; Steno Diabetes Center Copenhagen
- Sarah Uldal🇩🇰Copenhagen University Hospital; Steno Diabetes Center Copenhagen
- Joachim Størling🇩🇰University of Copenhagen; Copenhagen University Hospital; Steno Diabetes Center Copenhagen
- Nicolai J. Wewer Albrechtsen🇩🇰University of Copenhagen; Bispebjerg Hospital
- Jens Juul Holst🇩🇰University of Copenhagen; Novo Nordisk Foundation Center for Basic Metabolic Research
- Signe S. Torekov🇩🇰University of Copenhagen
- Martin Erik Nyeland🇩🇰Copenhagen University Hospital; Steno Diabetes Center Copenhagen
- Dorte Vistisen🇩🇰University of Copenhagen; Copenhagen University Hospital; Steno Diabetes Center Copenhagen
- Marit E. Jørgensen🇩🇰University of Southern Denmark; Copenhagen University Hospital; Steno Diabetes Center Copenhagen
- Satchidananda Panda🇺🇸Salk Institute for Biological Studies
- Christina Brock🇩🇰Aalborg University Hospital; Mech-Sense; Steno Diabetes Center North Jutland; Aalborg University
- Graham Finlayson🇬🇧🇩🇰University of Leeds; Copenhagen University Hospital; Steno Diabetes Center Copenhagen
- Martin Bæk Blond🇩🇰Copenhagen University Hospital; Steno Diabetes Center Copenhagen
- Kristine Færch🇩🇰University of Copenhagen; Novo Nordisk (Denmark); Copenhagen University Hospital; Steno Diabetes Center Copenhagen
Resumen
El texto original del estudio, en el idioma en que se publicó.
Background
Time-restricted eating (TRE) has been suggested to be a simple, feasible, and effective dietary strategy for individuals with overweight or obesity. We aimed to investigate the effects of 3 months of 10-h per-day TRE and 3 months of follow-up on bodyweight and cardiometabolic risk factors in individuals at high risk of type 2 diabetes.
Methods
This was a single-centre, parallel, superiority, open-label randomised controlled clinical trial conducted at Steno Diabetes Center Copenhagen (Denmark). The inclusion criteria were age 30-70 years with either overweight (ie, BMI ≥25 kg/m2) and concomitant prediabetes (ie, glycated haemoglobin [HbA1c] 39-47 mmol/mol) or obesity (ie, BMI ≥30 kg/m2) with or without prediabetes and a habitual self-reported eating window (eating and drinking [except for water]) of 12 h per day or more every day and of 14 h per day or more at least 1 day per week. Individuals were randomly assigned 1:1 to 3 months of habitual living (hereafter referred to as the control group) or TRE, which was a self-selected 10-h per-day eating window placed between 0600 h and 2000 h. Randomisation was done in blocks varying in size and was open for participants and research staff, but outcome assessors were masked during statistical analyses. The randomisation list was generated by an external statistician. The primary outcome was change in bodyweight, assessed after 3 months (12 weeks) of the intervention and after 3 months (13 weeks) of follow-up. Adverse events were reported and registered at study visits or if participants contacted study staff to report events between visits. This trial is registered on ClinicalTrials.gov (NCT03854656).
Findings
Between March 12, 2019, and March 2, 2022, 100 participants (66 [66%] were female and 34 [34%] were male; median age 59 years [IQR 52-65]) were enrolled and randomly assigned (50 to each group). Of those 100, 46 (92%) in the TRE group and 46 (92%) in the control group completed the intervention period. After 3 months of the intervention, there was no difference in bodyweight between the TRE group and the control group (-0·8 kg, 95% CI -1·7 to 0·2; p=0·099). Being in the TRE group was not associated with a lower bodyweight compared with the control group after subsequent 3-month follow-up (-0·2 kg, -1·6 to 1·2). In the per-protocol analysis, participants who completed the intervention in the TRE group lost 1·0 kg (-1·9 to -0·0; p=0·040) bodyweight compared with the control group after 3 months of intervention, which was not maintained after the 3-month follow-up period (-0·4 kg, -1·8 to 1·0). During the trial and follow-up period, one participant in the TRE group reported a severe adverse event: development of a subcutaneous nodule and pain when the arm was in use. This side-effect was evaluated to be related to the trial procedures.
Interpretation
3 months of 10-h per-day TRE did not lead to clinically relevant effects on bodyweight in middle-aged to older individuals at high risk of type 2 diabetes.
Funding
Novo Nordisk Foundation, Aalborg University, Helsefonden, and Innovation Fund Denmark.
Resumen vía Europe PMC. Los derechos de autor siguen siendo de los autores o la editorial (CC BY-NC-ND).
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