Acute Time-Restricted Eating in Young Healthy Males

Obesity Prevention Clinical Trial

Official title:

The Effect of Acute Time-Restricted Eating on Energy Intake, Subjective Appetite and Glycaemic Control in Young Healthy Males

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05309798
• Other study ID #: WM_eFAST_2020
• Status: Completed
• Phase: N/A
• Start date: January 14, 2019
• Est. completion date: December 13, 2019

Study information

• Verified date: March 2022
• Source: Nottingham Trent University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: December 13, 2019
• Est. primary completion date: December 13, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 30 Years

Eligibility

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.

Related Conditions & MeSH terms

• Obesity Prevention

Intervention

Behavioral:
• Evening Fasting
Participants will undertake acute evening fasting (feeding between 8am-4pm) for one day. After which they will attend the laboratory, following a 16 h fast, where baseline measures will be taken and the response to a standardised meal will take place. The participant will also have an opportunity to feed ad-libitum before they leave the laboratory.
• Morning Fasting
Participants will undertake an acute morning fasting trial (feeding between 12pm-8pm). After which, participants will visit the laboratory the following day, after a 16 h fast, where baseline measures will be taken and the response to a standardised meal will take place. The participant will also have an opportunity to feed ad-libitum before they leave the laboratory.
• Control
Participants will undertake an acute standard western feeding pattern (feeding between 8am-8pm). After which, participants will visit the laboratory the following day, after a 12 h fast, where baseline measures will be taken and the response to a standardised meal will take place. The participant will also have an opportunity to feed ad-libitum before they leave the laboratory.

Locations

Country	Name	City	State
United Kingdom	Nottingham Trent University	Nottingham	Nottinghamshire

Sponsors (2)

Lead Sponsor	Collaborator
Nottingham Trent University	Loughborough University

Country where clinical trial is conducted

United Kingdom, 

References & Publications (8)

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. Review. — View 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. do — View 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). pii: E1234. doi: — View Citation

Popkin BM. The nutrition transition and obesity in the developing world. J Nutr. 2001 Mar;131(3):871S-873S. Review. — View 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.2251 — View 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 Cardio — View 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. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glycaemic Control	A metabolic assessment lasting 3.5 hours will take place following a standardised, laboratory-based meal. The investigators will be taking periodic capillary and venous blood samples to measure post-prandial glucose and insulin, which together comprise 'glycaemic control'.	0 hour (Pre breakfast), 1 hour, 2 hour, 3.5 hour
Secondary	Energy Intake	Energy intake will be measured both during lab and outside of the laboratory when the participants are free-living. During lab, energy intake will be measured through ad-libitum feeding buffet where 20 minutes will be permitted to eat as much or as little as they desire, until 'comfortably full and satisfied', followed by post-feeding measurement of the remaining food.	3.5 hour following breakfast
Secondary	Energy expenditure	Energy expenditure will be measured via a chest-worn device (Actiheart) which combines heart rate and accelerometry to gauge calories expended.	Activity recorded across day 1 standardisation and day 2 (lab visit and post lab visit)
Secondary	Visual analogue scale for subjective ratings of appetite	Subjective appetite will be measured on mobile devices via a software which replicates a 100mm visual analogue scale. The scale is divided into subscales of different appetite perceptions including: hunger, fullness, desire to eat and prospective food consumption. This will be measured on a scale of 0-100 (0 - none at all) (100 - a lot).	0 hour (pre-breakfast), 1 hour, 2 hour, 3 hour, 4 hour (post breakfast during lab visit)
Secondary	Acylated Ghrelin (Appetite hormone)	Acylated Ghrelin will be measured from the venous samples taken during the post-prandial period following the standardised meal.	0 hour (pre breakfast), 1 hour, 2 hour, and 3 hour post breakfast
Secondary	PYY (Appetite hormone)	Acylated Ghrelin will be measured from the venous samples taken during the post-prandial period following the standardised meal.	0 hour (pre-breakfast), 1 hour, 2 hour, and 3 hour post breakfast
Secondary	Carbohydrate Oxidation	Investigators will be collecting expired air into Douglas bags, and measuring the VO2 and VCO2 concentration to calculate carbohydrate oxidation.	0 hour (pre breakfast), 1 hour, 2 hour, 3 hour post breakfast
Secondary	Fat Oxidation	Investigators will be collecting expired air into Douglas bags, and measuring the VO2 and VCO2 concentration to calculate fat oxidation.	0 hour (pre breakfast), 1 hour, 2 hour, 3 hour