NCT04742530

Brief Summary

This study will compare the appetite, energy intake, and exercise performance responses to a bout of exercise completed in the evening after an extended period of fasting with a similar bout of exercise completed in the evening and the morning, after consuming a carbohydrate-containing meal.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
16

participants targeted

Target at below P25 for not_applicable obesity

Timeline
Completed

Started Feb 2021

Shorter than P25 for not_applicable obesity

Geographic Reach
1 country

2 active sites

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

First Submitted

Initial submission to the registry

January 27, 2021

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 8, 2021

Completed
Same day until next milestone

Study Start

First participant enrolled

February 8, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 23, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 23, 2021

Completed
Last Updated

August 5, 2021

Status Verified

August 1, 2021

Enrollment Period

5 months

First QC Date

January 27, 2021

Last Update Submit

August 4, 2021

Conditions

Keywords

Fasted exerciseEnergy intakeEnergy balanceAppetiteExercise performance

Outcome Measures

Primary Outcomes (2)

  • Voluntary energy intake (Kilocalories) at a laboratory-based test meal

    A laboratory-based meal consisting of pasta, tomato sauce and olive oil will be provided to participants in excess of expected consumption. Participants will be permitted 20 minutes to eat as much or as little as they desire, until 'comfortably full and satisfied'.

    15 minutes following the end of the exercise session.

  • Exercise Performance (Voluntary Energy Expenditure)

    Maximum energy expenditure (Kilojoules) that can be completed within 15 minutes on a stationary bicycle ergometer. The participant will be able to alter their power output by selecting up or down on the ergometer control unit as they please.

    Within the 15-minute performance test component of the exercise session.

Secondary Outcomes (5)

  • Visual Analogue Scale for Subjective Ratings of Appetite

    Baseline, 2 hours, 3 hours, 3.5 hours, 5 hours, 7 hours, 8 hours, 10 hours, 11 hours, 12 hours, 14 hours, and 24 hours.

  • Substrate Utilisation During Steady State Exercise.

    Within the 30-minute steady-state component of the exercise session.

  • Rating of Perceived Exertion (RPE).

    Within the 45-minute exercise session.

  • Enjoyment of the Exercise Bout

    Immediately following the end of the exercise session.

  • Pre-exercise Subjective Feelings

    Immediately before the exercise session.

Study Arms (3)

Fasted Evening Exercise

EXPERIMENTAL

Exercise will take place in the evening, following a 7 hour period of fasting.

Behavioral: Fasted Evening Exercise

Fed Evening Exercise

ACTIVE COMPARATOR

Exercise will take place in the evening, after having consumed a carbohydrate-containing meal 2 hours prior.

Behavioral: Fed Evening Exercise

Fed Morning Exercise

ACTIVE COMPARATOR

Exercise will take place in the morning, after having consumed a carbohydrate-containing meal 2 hours prior.

Behavioral: Fed Morning Exercise

Interventions

A 45 minute exercise session will take place on a stationary cycle ergometer at 18:30, after a 7-hour period of fasting. This will consist of 30 minutes of steady state cycling at 60% of VO2max, followed by an exercise test during which participants will complete as much work as they can within 15 minutes.

Fasted Evening Exercise

A 45 minute exercise session will take place on a stationary cycle ergometer at 18:30, after having consumed a carbohydrate-containing meal (20% estimated energy requirements) 2 hours prior. This will consist of 30 minutes of steady state cycling at 60% of VO2max, followed by an exercise test during which participants will complete as much work as they can within 15 minutes.

Fed Evening Exercise

A 45 minute exercise session will take place on a stationary cycle ergometer at 10:30, after having consumed a carbohydrate-containing meal (20% estimated energy requirements) 2 hours prior. This will consist of 30 minutes of steady state cycling at 60% of VO2max, followed by an exercise test during which participants will complete as much work as they can within 15 minutes.

Fed Morning Exercise

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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).

You may not qualify if:

  • Have an unusual eating pattern (i.e., extended fasting periods \>8h other than overnight - self-reported).
  • 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).
  • Having received a positive COVID-19 test in the 6-month period prior to participation.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Loughborough University

Loughborough, LE11 3TU, United Kingdom

Location

Nottingham Trent University

Nottingham, NG11 8NS, United Kingdom

Location

Related Publications (11)

  • Edinburgh RM, Hengist A, Smith HA, Travers RL, Betts JA, Thompson D, Walhin JP, Wallis GA, Hamilton DL, Stevenson EJ, Tipton KD, Gonzalez JT. Skipping Breakfast Before Exercise Creates a More Negative 24-hour Energy Balance: A Randomized Controlled Trial in Healthy Physically Active Young Men. J Nutr. 2019 Aug 1;149(8):1326-1334. doi: 10.1093/jn/nxz018.

    PMID: 31321428BACKGROUND
  • Bachman JL, Deitrick RW, Hillman AR. Exercising in the Fasted State Reduced 24-Hour Energy Intake in Active Male Adults. J Nutr Metab. 2016;2016:1984198. doi: 10.1155/2016/1984198. Epub 2016 Sep 21.

    PMID: 27738523BACKGROUND
  • Clayton DJ, Barutcu A, Machin C, Stensel DJ, James LJ. Effect of Breakfast Omission on Energy Intake and Evening Exercise Performance. Med Sci Sports Exerc. 2015 Dec;47(12):2645-52. doi: 10.1249/MSS.0000000000000702.

    PMID: 25970668BACKGROUND
  • McIver VJ, Mattin LR, Evans GH, Yau AMW. Diurnal influences of fasted and non-fasted brisk walking on gastric emptying rate, metabolic responses, and appetite in healthy males. Appetite. 2019 Dec 1;143:104411. doi: 10.1016/j.appet.2019.104411. Epub 2019 Aug 21.

    PMID: 31445052BACKGROUND
  • James LJ, Moss J, Henry J, Papadopoulou C, Mears SA. Hypohydration impairs endurance performance: a blinded study. Physiol Rep. 2017 Jun;5(12):e13315. doi: 10.14814/phy2.13315.

    PMID: 28637708BACKGROUND
  • Metcalfe RS, Thomas M, Lamb C, Chowdhury EA. Omission of a carbohydrate-rich breakfast impairs evening endurance exercise performance despite complete dietary compensation at lunch. Eur J Sport Sci. 2021 Jul;21(7):1013-1021. doi: 10.1080/17461391.2020.1797890. Epub 2020 Aug 27.

    PMID: 32674691BACKGROUND
  • Maffucci DM, McMurray RG. Towards optimizing the timing of the pre-exercise meal. Int J Sport Nutr Exerc Metab. 2000 Jun;10(2):103-13. doi: 10.1123/ijsnem.10.2.103.

    PMID: 10861332BACKGROUND
  • Wallis GA, Gonzalez JT. Is exercise best served on an empty stomach? Proc Nutr Soc. 2019 Feb;78(1):110-117. doi: 10.1017/S0029665118002574. Epub 2018 Oct 18.

    PMID: 30334499BACKGROUND
  • Kendzierski, D., & DeCarlo, K. J. (1991). Physical Activity Enjoyment Scale: Two Validation Studies. Journal of Sport and Exercise Psychology, 13(1), 50-64. doi:10.1123/jsep.13.1.50.

    BACKGROUND
  • Raedeke, T. D. (2007). The Relationship Between Enjoyment and Affective Responses to Exercise. Journal of Applied Sport Psychology, 19(1), 105-115. doi:10.1080/10413200601113638

    BACKGROUND
  • Mode WJA, Slater T, Pinkney MG, Hough J, James RM, Varley I, James LJ, Clayton DJ. Effects of Morning Vs. Evening exercise on appetite, energy intake, performance and metabolism, in lean males and females. Appetite. 2023 Mar 1;182:106422. doi: 10.1016/j.appet.2022.106422. Epub 2022 Dec 17.

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

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

Study Record Dates

First Submitted

January 27, 2021

First Posted

February 8, 2021

Study Start

February 8, 2021

Primary Completion

June 23, 2021

Study Completion

June 23, 2021

Last Updated

August 5, 2021

Record last verified: 2021-08

Locations