An interventional study of Extended Evening Fasting and Control in Obesity, sponsored by Nottingham Trent University. Status unknown at 1 site in United Kingdom. Open to participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-03-31.
Sponsored by Nottingham Trent University · Not applicable, Interventional, and Prevention
This study will compare metabolic and feeding behaviour responses to 4 days of extended evening fasting vs. a control trial
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.
Nottingham Trent University is the lead sponsor of 28 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Non-smokers.
Exclusion Criteria:
Severe food allergies, dislike or intolerance of study foods or drinks.
Participants will eat between 8am-4pm
Behavioral: Extended Evening Fasting
Participants will eat between 8am-8pm
Behavioral: Control
Participants will undertake 4 days of extended evening fasting (feeding between 8am-4pm). The participants will visit the laboratory on day 1, 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. The participant will continue to adhere to the feeding window on day 2 and day 3, although this will be in free-living conditions. On day 4, the participant will arrive back to the lab for post-intervention assessment, identical in format to day 1 with a metabolic assessment and energy intake assessment via a ad-libitum meal.
Participants will undertake 4 days of a standard western feeding pattern (feeding between 8am-8pm). The participants will visit the laboratory on day 1, following 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. The participant will continue to adhere to the feeding window on day 2 and day 3, although this will be in free-living conditions. On day 4, the participant will arrive back to the lab for post-intervention assessment, identical in format to day 1 with a metabolic assessment and energy intake assessment via a ad-libitum meal.
Glycaemic control (Baseline)
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'.
Time frame: 3.5 hours following the standardised breakfast meal on day 1.
Glycaemic control (Post intervention)
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'.
Time frame: 3.5 hours following the standardised breakfast meal on day 4.
Energy Intake (Kilocalories)
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. Outside of laboratory feeding will also be monitored through food diary's and weighing any investigator issued meals.
Time frame: Day 1 to day 4.
Energy expenditure
Energy expenditure will be measured via a chest-worn device (Actiheart) which combines heart rate and accelerometry to gauge calories expended.
Time frame: Day 1 to day 4.
Cortisol awakening response
The cortisol awakening response will be measured on the final morning of each trial.
Time frame: Five samples will be collected by the participant within the first hour of waking on day 5.
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. (i.e. from 0 - 100), with a rating of 100 fully supporting the perception and a rating of 0 fully opposing the perception.
Time frame: Every 2 hours between 8am-10pm from day 1 to day 4.
Acylated Ghrelin (appetite hormone)
Acylated Ghrelin will be measured from the venous samples taken during the post-prandial period following the standardised meal.
Time frame: 3.5 hours following the standardised breakfast meal on day 1 and day 4.
PYY (appetite hormone)
PYY will be measured from the venous samples taken during the post-prandial period following the standardised meal.
Time frame: 3.5 hours following the standardised breakfast meal on day 1 and day 4.
Carbohydrate oxidation
Investigators will be collecting expired air into Douglas bags, and measuring the VO2 and VCO2 concentration to calculate carbohydrate oxidation.
Time frame: During laboratory visits on day 1 and day 4 [baseline, 60min, 120min, 180min]
Fat oxidation
Investigators will be collecting expired air into Douglas bags, and measuring the VO2 and VCO2 concentration to calculate fat oxidation.
Time frame: During laboratory visits on day 1 and day 4 [baseline, 60min, 120min, 180min]
Plan to share: Undecided
This study is status unknown, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Nottingham Trent University