Extended Evening Fasting: Metabolic Health and Energy Balance

NCT ID: NCT04924517

Last Updated: 2022-03-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-14

Study Completion Date

2022-06-14

Brief Summary

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This study will compare metabolic and feeding behaviour responses to 4 days of extended evening fasting vs. a control trial

Detailed Description

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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

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Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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.
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Extended Evening Fasting

Participants will eat between 8am-4pm

Group Type EXPERIMENTAL

Extended Evening Fasting

Intervention Type BEHAVIORAL

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.

Control

Participants will eat between 8am-8pm

Group Type ACTIVE_COMPARATOR

Control

Intervention Type BEHAVIORAL

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.

Interventions

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Extended Evening Fasting

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.

Intervention Type BEHAVIORAL

Control

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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).

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Nottingham Trent University

OTHER

Sponsor Role lead

Responsible Party

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William Mode

Principle Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Nottingham Trent University

Nottingham, Greater London, United Kingdom

Site Status RECRUITING

Countries

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United Kingdom

Central Contacts

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William Mode, MRes

Role: CONTACT

+447484751219

David Clayton, PhD

Role: CONTACT

(+44) 115 848 5514

Facility Contacts

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David Clayton, PhD

Role: primary

(+44) 115 848 5514

References

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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.

Reference Type BACKGROUND
PMID: 29754952 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31151228 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31339000 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31002478 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31023390 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11238777 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29486170 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28137935 (View on PubMed)

Other Identifiers

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WM_EEF_2021

Identifier Type: -

Identifier Source: org_study_id

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