NCT05309798

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 14, 2019

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 13, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 13, 2019

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

March 16, 2022

Completed
19 days until next milestone

First Posted

Study publicly available on registry

April 4, 2022

Completed
Last Updated

April 4, 2022

Status Verified

March 1, 2022

Enrollment Period

11 months

First QC Date

March 16, 2022

Last Update Submit

March 24, 2022

Conditions

Keywords

ChrononutritionTime-Restricted EatingEnergy BalanceGlycaemic Control

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (7)

  • Energy Intake

    3.5 hour following breakfast

  • Energy expenditure

    Activity recorded across day 1 standardisation and day 2 (lab visit and post lab visit)

  • Visual analogue scale for subjective ratings of appetite

    0 hour (pre-breakfast), 1 hour, 2 hour, 3 hour, 4 hour (post breakfast during lab visit)

  • Acylated Ghrelin (Appetite hormone)

    0 hour (pre breakfast), 1 hour, 2 hour, and 3 hour post breakfast

  • PYY (Appetite hormone)

    0 hour (pre-breakfast), 1 hour, 2 hour, and 3 hour post breakfast

  • +2 more secondary outcomes

Study Arms (3)

Evening Fasting

EXPERIMENTAL

Participants will undertake acute evening fasting (feeding between 8am-4pm)

Behavioral: Evening Fasting

Control

EXPERIMENTAL

Participants will undertake an acute standard western feeding pattern (feeding between 8am-8pm).

Behavioral: Control

Morning Fasting

EXPERIMENTAL

Participants will undertake an acute morning fasting trial (feeding between 12pm-8pm).

Behavioral: Morning Fasting

Interventions

Evening FastingBEHAVIORAL

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.

Evening Fasting
Morning FastingBEHAVIORAL

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.

Morning Fasting
ControlBEHAVIORAL

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.

Control

Eligibility Criteria

Age18 Years - 30 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nottingham Trent University

Nottingham, Nottinghamshire, NG2 5BL, United Kingdom

Location

Related Publications (8)

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

MeSH Terms

Conditions

Intermittent Fasting

Condition Hierarchy (Ancestors)

FastingFeeding BehaviorBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Model Details: The study design is a randomised, controlled, crossover design in which participants undertake three conditions in a randomised order with at least one week in between trials.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

March 16, 2022

First Posted

April 4, 2022

Study Start

January 14, 2019

Primary Completion

December 13, 2019

Study Completion

December 13, 2019

Last Updated

April 4, 2022

Record last verified: 2022-03

Locations