Clinical trial NCT05309798: Acute Time-Restricted Eating in Young Healthy Males
Official title: The Effect of Acute Time-Restricted Eating on Energy Intake, Subjective Appetite and Glycaemic Control in Young Healthy Males
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity Prevention
Keywords: Chrononutrition
Time-Restricted Eating
Energy Balance
Glycaemic Control
Lead sponsor: Nottingham Trent University
Sponsor class: OTHER
Collaborators: name: Loughborough University
First posted: 2022-04-04
Enrollment: 18
Sex: MALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: The study design is a randomised, controlled, crossover design in which participants undertake three conditions in a randomised order with at least one week in between trials.
Primary purpose: PREVENTION

Brief summary: This study compared the metabolic response to three different eating windows (morning fast,12pm-8pm; evening fast, 8am-4pm; control, 8am-8pm).

Detailed description: Humans have evolved as a diurnal species, internally governed by the circadian system, which dictates our hormone regulation. 'Chrononutrition' is a sub-discipline which combines food timing with circadian physiology. The most popular method of time-restricted feeding in the UK is to skip breakfast. However, data from several meta-analysis have shown that skipping breakfast is associated with weight gain and insulin resistance, likely due to eating later into the evening/night and therefore, out of sync with our circadian rhythm. Recent research has shown that skipping dinner (evening fasting) has improved markers of cardio-metabolic health in clinical populations, although these are typically from longer-term studies. Despite these promising findings, it is not yet known whether these findings are population specific.

Therefore, the investigators are interested in examining the metabolic response pre and post-intervention to see whether these promising findings can translate into a healthy population. Furthermore, the investigators will be monitoring subjective appetite, energy intake, and expenditure to assess whether there is any short-term adaptation to a specific feeding window.

Eligibility criteria: Inclusion Criteria:

* recreationally active
* non-smokers
* non-dieting
* weight stable (self-reported for \>6 months)
* were not consuming any medication known to affect appetite or physical activity

Exclusion Criteria:

* Smokers
* \>10 hours per week physical activity
* Have dieted within the past 6 months
* Excessive alcohol consumption (\>14 units/week)
* Use of medication or supplements that may affect hormone concentrations.

Primary outcomes:
measure: Glycaemic Control
timeFrame: 0 hour (Pre breakfast), 1 hour, 2 hour, 3.5 hour
Secondary outcomes:
measure: Energy Intake
timeFrame: 3.5 hour following breakfast
measure: Energy expenditure
timeFrame: Activity recorded across day 1 standardisation and day 2 (lab visit and post lab visit)
measure: Visual analogue scale for subjective ratings of appetite
timeFrame: 0 hour (pre-breakfast), 1 hour, 2 hour, 3 hour, 4 hour (post breakfast during lab visit)
measure: Acylated Ghrelin (Appetite hormone)
timeFrame: 0 hour (pre breakfast), 1 hour, 2 hour, and 3 hour post breakfast
measure: PYY (Appetite hormone)
timeFrame: 0 hour (pre-breakfast), 1 hour, 2 hour, and 3 hour post breakfast
measure: Carbohydrate Oxidation
timeFrame: 0 hour (pre breakfast), 1 hour, 2 hour, 3 hour post breakfast
measure: Fat Oxidation
timeFrame: 0 hour (pre breakfast), 1 hour, 2 hour, 3 hour
Other outcomes:
Locations:
city: Nottingham
country: United Kingdom
facility: Nottingham Trent University
state: Nottinghamshire
Study officials:
References:
citation: Sutton EF, Beyl R, Early KS, Cefalu WT, Ravussin E, Peterson CM. Early Time-Restricted Feeding Improves Insulin Sensitivity, Blood Pressure, and Oxidative Stress Even without Weight Loss in Men with Prediabetes. Cell Metab. 2018 Jun 5;27(6):1212-1221.e3. doi: 10.1016/j.cmet.2018.04.010. Epub 2018 May 10.
citation: Jamshed H, Beyl RA, Della Manna DL, Yang ES, Ravussin E, Peterson CM. Early Time-Restricted Feeding Improves 24-Hour Glucose Levels and Affects Markers of the Circadian Clock, Aging, and Autophagy in Humans. Nutrients. 2019 May 30;11(6):1234. doi: 10.3390/nu11061234.
citation: Ravussin E, Beyl RA, Poggiogalle E, Hsia DS, Peterson CM. Early Time-Restricted Feeding Reduces Appetite and Increases Fat Oxidation But Does Not Affect Energy Expenditure in Humans. Obesity (Silver Spring). 2019 Aug;27(8):1244-1254. doi: 10.1002/oby.22518.
citation: Hutchison AT, Regmi P, Manoogian ENC, Fleischer JG, Wittert GA, Panda S, Heilbronn LK. Time-Restricted Feeding Improves Glucose Tolerance in Men at Risk for Type 2 Diabetes: A Randomized Crossover Trial. Obesity (Silver Spring). 2019 May;27(5):724-732. doi: 10.1002/oby.22449. Epub 2019 Apr 19.
citation: Templeman I, Gonzalez JT, Thompson D, Betts JA. The role of intermittent fasting and meal timing in weight management and metabolic health. Proc Nutr Soc. 2020 Feb;79(1):76-87. doi: 10.1017/S0029665119000636. Epub 2019 Apr 26.
citation: Popkin BM. The nutrition transition and obesity in the developing world. J Nutr. 2001 Mar;131(3):871S-873S. doi: 10.1093/jn/131.3.871S.
citation: Allison KC, Goel N. Timing of eating in adults across the weight spectrum: Metabolic factors and potential circadian mechanisms. Physiol Behav. 2018 Aug 1;192:158-166. doi: 10.1016/j.physbeh.2018.02.047. Epub 2018 Feb 24.
citation: St-Onge MP, Ard J, Baskin ML, Chiuve SE, Johnson HM, Kris-Etherton P, Varady K; American Heart Association Obesity Committee of the Council on Lifestyle and Cardiometabolic Health; Council on Cardiovascular Disease in the Young; Council on Clinical Cardiology; and Stroke Council. Meal Timing and Frequency: Implications for Cardiovascular Disease Prevention: A Scientific Statement From the American Heart Association. Circulation. 2017 Feb 28;135(9):e96-e121. doi: 10.1161/CIR.0000000000000476. Epub 2017 Jan 30.