Extended Evening Fasting: Metabolic Health and Energy Balance

March 16, 2022 updated by: William Mode, Nottingham Trent University

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United Kingdom
    • Greater London
      • Nottingham, Greater London, United Kingdom, NG11 8NS
        • Recruiting
        • Nottingham Trent University
        • Contact:
        • Principal Investigator:
          • William Mode, MRes
        • Sub-Investigator:
          • David Clayton, PhD
        • Sub-Investigator:
          • John Hough, PhD
        • Sub-Investigator:
          • Ruth James, PhD
        • Sub-Investigator:
          • Ian Varley, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Extended Evening Fasting
Participants will eat between 8am-4pm
Behavioral: 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.
Active Comparator: Control
Participants will eat between 8am-8pm
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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'.
3.5 hours following the standardised breakfast meal on day 1.
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'.
3.5 hours following the standardised breakfast meal on day 4.
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.
Day 1 to day 4.
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.
Day 1 to day 4.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cortisol awakening response
Time Frame: Five samples will be collected by the participant within the first hour of waking on day 5.
The cortisol awakening response will be measured on the final morning of each trial.
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.

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.
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.
Acylated Ghrelin will be measured from the venous samples taken during the post-prandial period following the standardised meal.
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.
PYY will be measured from the venous samples taken during the post-prandial period following the standardised meal.
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]
Investigators will be collecting expired air into Douglas bags, and measuring the VO2 and VCO2 concentration to calculate carbohydrate oxidation.
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]
Investigators will be collecting expired air into Douglas bags, and measuring the VO2 and VCO2 concentration to calculate fat oxidation.
During laboratory visits on day 1 and day 4 [baseline, 60min, 120min, 180min]

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nottingham Trent University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 14, 2021

Primary Completion (Anticipated)

June 14, 2022

Study Completion (Anticipated)

June 14, 2022

Study Registration Dates

First Submitted

May 24, 2021

First Submitted That Met QC Criteria

June 10, 2021

First Posted (Actual)

June 14, 2021

Study Record Updates

Last Update Posted (Actual)

March 31, 2022

Last Update Submitted That Met QC Criteria

March 16, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • WM_EEF_2021

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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