ObesityNCT04924517
Extended Evening Fasting: Metabolic Health and Energy Balance
A study testing Extended Evening Fasting in people with Obesity, run by Nottingham Trent University at 1 site in United Kingdom.
Trial summary
This study will compare metabolic and feeding behaviour responses to 4 days of extended evening fasting vs. a control trial Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Extended Evening Fasting
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 14 Sep 2021to 14 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Non-smokers.
- Have maintained a stable weight for 6 months (self-reported).
- No history of gastric, digestive, cardiovascular or renal disease (self reported).
- Female specific: must be using a monophasic, low dose combined OCP (containing less than 50μg oestradiol and a synthetic progestin) OR females with regular menstrual cycles (self-reported).
Who cannot join
- Severe food allergies, dislike or intolerance of study foods or drinks.
- Currently undergoing a lifestyle intervention (structured diet or exercise)
- Diagnosis of a condition or currently undergoing treatment therapy known to affect glucose or lipid metabolism (e.g., type-2 diabetes, taking statins), or contraindications to exercise.
- Use of medication or supplements that may affect hormone concentrations.
- Excessive alcohol consumption (>14 units/week).
- Intensive training schedule (>10 hours/week).
- Female specific: currently pregnant or breastfeeding, the use of any hormonal contraception, and the self-reporting of short (<24 d), long (>35 d), or irregular menstrual cycles.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Nottingham Trent University
Nottingham, Greater London, NG11 8NS
David Clayton, PhD, (+44) 115 848 5514, david.clayton@ntu.ac.uk
William Mode, MRes
About this study
Official title: The Effect of 4 Days of Extended Evening Fasting on Metabolic Health, Energy Balance and Appetite
This study will compare metabolic and feeding behaviour responses to 4 days of extended evening fasting vs. a control trial
Read the 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.
- Conditions
- Obesity
- Being tested
- Extended Evening Fasting, Control
- Keywords
- Chrononutrition, Energy balance, Intermittent fasting, Appetite hormones
- Medical subject headings
- Obesity, Intermittent Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extended Evening FastingBehavioural
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.
ControlBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Extended Evening Fasting | Experimental | Participants will eat between 8am-4pm Receives: Behavioral: Extended Evening Fasting |
| Control | Active comparator | Participants will eat between 8am-8pm Receives: Behavioral: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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'.
Measured: 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'.
Measured: 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.
Measured: 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.
Measured: Day 1 to day 4.
Secondary outcomes (6)
Cortisol awakening response
The cortisol awakening response will be measured on the final morning of each trial.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: During laboratory visits on day 1 and day 4 [baseline, 60min, 120min, 180min]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2021
- Study start14 Sep 2021
- Primary completion14 Jun 2022 (estimated)
- Study completion14 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- The study design is a randomised, controlled, crossover design in which participants undertake two conditions in a randomised order with at least four weeks in between trials.
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nottingham Trent University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, William Mode, Nottingham Trent University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04924517
- Sponsor's protocol ID
- WM_EEF_2021
- Status last verified
- Mar 2022
- First submitted
- 24 May 2021
- Last updated
- 31 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 29754952Jamshed 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.
PubMed 31151228Ravussin 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.
PubMed 31339000Hutchison 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.
PubMed 31002478Templeman 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.
PubMed 31023390Popkin 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.
PubMed 11238777Allison 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.
PubMed 29486170St-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.
PubMed 28137935
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of 4 Days of Extended Evening Fasting on Metabolic Health, Energy Balance and Appetite
- ClinicalTrials.gov ID
- NCT04924517
- Acronym / sponsor ID
- WM_EEF_2021
- Conditions
- Obesity
- Keywords
- Chrononutrition, Energy balance, Intermittent fasting, Appetite hormones
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Nottingham Trent UniversityUniversity, hospital or other
- Study start
- 14 Sep 2021 (actual)
- Primary completion
- 14 Jun 2022 (estimated)
- Study completion
- 14 Jun 2022 (estimated)
- First posted
- 14 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will compare metabolic and feeding behaviour responses to 4 days of extended evening fasting vs. a control trial
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study design is a randomised, controlled, crossover design in which participants undertake two conditions in a randomised order with at least four weeks in between trials.
| Arm | Type | Receives |
|---|---|---|
| Extended Evening Fasting | Experimental | Behavioral: Extended Evening FastingParticipants will eat between 8am-4pm |
| Control | Active comparator | Behavioral: ControlParticipants will eat between 8am-8pm |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Non-smokers.
Key exclusion criteria (7 listed)
- Severe food allergies, dislike or intolerance of study foods or drinks.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Extended Evening FastingParticipants 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. | Behavioural | Extended Evening Fasting |
| ControlParticipants 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. | Behavioural | Control |
Primary outcome
Glycaemic control (Baseline)
Time frame: 3.5 hours following the standardised breakfast meal on day 1.
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'.
Glycaemic control (Post intervention)
Time frame: 3.5 hours following the standardised breakfast meal on day 4.
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'.
Energy Intake (Kilocalories)
Time frame: Day 1 to day 4.
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.
Energy expenditure
Time frame: Day 1 to day 4.
Energy expenditure will be measured via a chest-worn device (Actiheart) which combines heart rate and accelerometry to gauge calories expended.
6 secondary outcomes
Cortisol awakening response
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
Time frame: Every 2 hours between 8am-10pm from day 1 to day 4.
Acylated Ghrelin (appetite hormone)
Time frame: 3.5 hours following the standardised breakfast meal on day 1 and day 4.
PYY (appetite hormone)
Time frame: 3.5 hours following the standardised breakfast meal on day 1 and day 4.
Carbohydrate oxidation
Time frame: During laboratory visits on day 1 and day 4 [baseline, 60min, 120min, 180min]
Fat oxidation
Time frame: During laboratory visits on day 1 and day 4 [baseline, 60min, 120min, 180min]
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2022.
- Background: PubMed 29754952Sutton 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.
- Background: PubMed 31151228Jamshed 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.
- Background: PubMed 31339000Ravussin 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.
- Background: PubMed 31002478Hutchison 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.
- Background: PubMed 31023390Templeman 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.
- Background: PubMed 11238777Popkin 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.
- Background: PubMed 29486170Allison 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.
- Background: PubMed 28137935St-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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Extended Evening Fasting in people with Obesity, run by Nottingham Trent University at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact William Mode, MRes (+447484751219, william_mode@hotmail.co.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glycaemic control (Baseline) (time frame: 3.5 hours following the standardised breakfast meal on day 1.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04924517, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2022.