NCT05107583

Brief Summary

This study will compare the metabolic, appetite, energy intake, and perceptual responses to a bout of exercise completed in the evening after after a low-carbohydrate lunch meal (\<10% carbohydrate content / 0.2 g/kg carbohydrate; LO-CHO), with the responses to exercise performed after a lunch meal containing a high carbohydrate content (\~60% carbohydrate content / 2.2 g/kg carbohydrate; HI-CHO), and after skipping lunch and fasting for 8 hours since breakfast (FAST).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for not_applicable obesity

Timeline
Completed

Started Sep 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

August 12, 2021

Completed
20 days until next milestone

Study Start

First participant enrolled

September 1, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 4, 2021

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2022

Completed
Last Updated

September 14, 2022

Status Verified

September 1, 2022

Enrollment Period

10 months

First QC Date

August 12, 2021

Last Update Submit

September 13, 2022

Conditions

Keywords

Fasted exerciseLow-carbohydrateHigh-proteinAppetiteEnergy IntakeMetabolism

Outcome Measures

Primary Outcomes (1)

  • Fat Oxidation Rate During Steady-State Exercise.

    Measurements of VO2 and VCO2 during a 60 minute steady state bout of cycling to determine rates of fat oxidation.

    Throughout the 60-minute steady-state bout of cycling

Secondary Outcomes (17)

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

    60 minutes following the end of the exercise session.

  • Visual Analogue Scale for Subjective Ratings of Appetite.

    Baseline, 1 hour, 1.75 hours, 2.75 hours, 3 hours, 3.5 hours (mid-exercise), 4 hours, 5 hours.

  • Acylated ghrelin

    Baseline, 1 hour, 1.75 hours, 2.75 hours, 3 hours, 3.5 hours (mid-exercise), 4 hours, 5 hours.

  • Peptide tyrosine-tyrosine (PYY)

    Baseline, 1 hour, 1.75 hours, 2.75 hours, 3 hours, 3.5 hours (mid-exercise), 4 hours, 5 hours.

  • Glucagon-like peptide-1 (GLP-1)

    Baseline, 1 hour, 1.75 hours, 2.75 hours, 3 hours, 3.5 hours (mid-exercise), 4 hours, 5 hours.

  • +12 more secondary outcomes

Study Arms (3)

Low-Carbohydrate Pre-Exercise Meal

EXPERIMENTAL

Participants will consume a low-carbohydrate (\<10% carbohydrate) lunch meal at 13:30 - 2.5 hours prior to commencing exercise at 16:00.

Behavioral: Low-Carbohydrate Pre-Exercise Meal

High-Carbohydrate Pre-Exercise Meal

EXPERIMENTAL

Participants will consume a high-carbohydrate (\~2.2 g/kg carbohydrate) lunch meal at 13:30 - 2.5 hours prior to commencing exercise at 16:00.

Behavioral: High-Carbohydrate Pre-Exercise Meal

Fasted Exercise

EXPERIMENTAL

Participants will skip lunch, and continue fasting since breakfast (08:00) before commencing exercise at 16:00. Therefore, exercise will commence after an 8 hour period of fasting.

Behavioral: Fasted Exercise

Interventions

Sixty minutes of cycling at 60% VO2peak will take place on a stationary bicycle ergometer at 16:00, after having consumed a low-carbohydrate lunch meal (\<10% carbohydrate; 35% estimated energy requirements) 2.5 hours prior.

Low-Carbohydrate Pre-Exercise Meal

Sixty minutes of cycling at 60% VO2peak will take place on a stationary bicycle ergometer at 16:00, after having consumed a high-carbohydrate lunch meal (\~2.2 g/kg carbohydrate; 35% estimated energy requirements) 2.5 hours prior.

High-Carbohydrate Pre-Exercise Meal
Fasted ExerciseBEHAVIORAL

Sixty minutes of cycling at 60% VO2peak will take place on a stationary bicycle ergometer at 16:00, after having skipped lunch, and having consumed nothing other than plain water since breakfast (08:00; 25% estimated energy requirements). Exercise will therefore commence after an 8 hour period of fasting.

Fasted Exercise

Eligibility Criteria

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

You may qualify if:

  • Non-smokers (due to the well-known impact of smoking on appetite.
  • Not currently on a weight management program or have an unusual eating pattern (i.e., extended fasting periods \>8 h other than overnight).
  • Have maintained a stable weight for 6 months (self-reported).
  • No history of gastric, digestive, cardiovascular or renal disease (self-reported).

You may not qualify if:

  • 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 and/or substrate metabolism.
  • Excessive alcohol consumption (\>14 units/week).
  • Intensive training schedule (\>10 hours/week).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Loughborough University

Loughborough, Leicestershire, LE11 3TU, United Kingdom

Location

Nottingham Trent University

Nottingham, Nottinghamshire, NG11 8NS, United Kingdom

Location

Related Publications (8)

  • Edinburgh RM, Bradley HE, Abdullah NF, Robinson SL, Chrzanowski-Smith OJ, Walhin JP, Joanisse S, Manolopoulos KN, Philp A, Hengist A, Chabowski A, Brodsky FM, Koumanov F, Betts JA, Thompson D, Wallis GA, Gonzalez JT. Lipid Metabolism Links Nutrient-Exercise Timing to Insulin Sensitivity in Men Classified as Overweight or Obese. J Clin Endocrinol Metab. 2020 Mar 1;105(3):660-76. doi: 10.1210/clinem/dgz104.

    PMID: 31628477BACKGROUND
  • Van Proeyen K, Szlufcik K, Nielens H, Pelgrim K, Deldicque L, Hesselink M, Van Veldhoven PP, Hespel P. Training in the fasted state improves glucose tolerance during fat-rich diet. J Physiol. 2010 Nov 1;588(Pt 21):4289-302. doi: 10.1113/jphysiol.2010.196493.

    PMID: 20837645BACKGROUND
  • 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
  • Rowlands DS, Hopkins WG. Effects of high-fat and high-carbohydrate diets on metabolism and performance in cycling. Metabolism. 2002 Jun;51(6):678-90. doi: 10.1053/meta.2002.32723.

    PMID: 12037719BACKGROUND
  • Oliveira CLP, Boule NG, Berg A, Sharma AM, Elliott SA, Siervo M, Ghosh S, Prado CM. Consumption of a High-Protein Meal Replacement Leads to Higher Fat Oxidation, Suppression of Hunger, and Improved Metabolic Profile After an Exercise Session. Nutrients. 2021 Jan 5;13(1):155. doi: 10.3390/nu13010155.

    PMID: 33466462BACKGROUND
  • 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
  • Rothschild JA, Kilding AE, Broome SC, Stewart T, Cronin JB, Plews DJ. Pre-Exercise Carbohydrate or Protein Ingestion Influences Substrate Oxidation but Not Performance or Hunger Compared with Cycling in the Fasted State. Nutrients. 2021 Apr 14;13(4):1291. doi: 10.3390/nu13041291.

    PMID: 33919779BACKGROUND

MeSH Terms

Conditions

ObesityMetabolic Syndrome

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsInsulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Due to the obvious differences between fasting and consuming food, participants will be aware of when they have been assigned to the fasted condition. However, the low- and high-carbohydrate content lunch meals will be closely matched for taste, with carbohydrate content being manipulated within a drink. Participants will not be informed that the carbohydrate content of the lunch meals is being manipulated, and will therefore, be blinded to this element of the study.
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

August 12, 2021

First Posted

November 4, 2021

Study Start

September 1, 2021

Primary Completion

June 30, 2022

Study Completion

June 30, 2022

Last Updated

September 14, 2022

Record last verified: 2022-09

Locations