ObesityNCT05107583
Effects of Pre-exercise Carbohydrate Restriction Relative to Fasting on Metabolism, Appetite, and Energy Intake in Healthy Males.
A study testing Low-Carbohydrate Pre-Exercise Meal, High-Carbohydrate Pre-Exercise Meal and Fasted Exercise in people with Obesity and Metabolic Syndrome, run by Nottingham Trent University at 2 sites in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity, Metabolic Syndrome
- What is being tested?
- Low-Carbohydrate Pre-Exercise Meal, High-Carbohydrate Pre-Exercise Meal and Fasted Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 1 Sep 2021to 30 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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).
Who cannot join
- 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).
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Loughborough University
Loughborough, Leicestershire, LE11 3TU
Nottingham Trent University
Nottingham, Nottinghamshire, NG11 8NS
About this study
Official title: Comparing the Effects of a High- and Low-carbohydrate Pre-exercise Meal Relative to Fasting on Exercise Metabolism, Subsequent Appetite, and Energy Intake in Healthy Males.
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).
Read the detailed description
Regular exercise is known to be a successful strategy for improving several facets of health and maintaining body weight. However, many people are not engaging in enough exercise, and some may not be achieving maximum benefits from the exercise that they already do. Performing exercise in the overnight fasted state has been shown to reduce energy intake over the course of a single day, without any compensatory reductions in free-living energy expenditure. Despite these promising findings, it is likely that not every member of the population is logistically able to perform exercise in the morning due to various work, family and social commitments, and exercise in the evening may be a logical alternative for these individuals.
Studies have found that exercise performed after an overnight fast may incur superior improvements in insulin sensitivity in lean individuals (Van Proeyen et al., 2010), and individuals with overweight or obesity (Edinburgh et al., 2020), compared to exercising after breakfast. These superior improvements may be mediated, in part, by an increased mobilisation and oxidation of endogenous lipid stores. Additionally, overnight fasted exercise may result in a more negative energy balance than exercising after breakfast (Bachman et al., 2016; Edinburgh et al., 2019). We recently examined whether exercise performed in the evening following an extended period of fasting (7 h) would induce similar responses to overnight fasted exercise regarding substrate oxidation patterns and subsequent energy intake (manuscript in preparation - NCT04742530). This research question was important, as we speculate that a large proportion of the population are likely unable to perform exercise in the morning after an overnight fast due to various logistical barriers. Therefore fasting prior to evening exercise could act as an alternative for these individuals.
We found that compared to consuming a carbohydrate-containing meal 2 h prior, fasting before evening exercise resulted in elevated fat oxidation rates during exercise, but was accompanied by compensatory eating at dinner. Additionally, participants reported that fasting throughout the afternoon was difficult. The long-term efficacy of fasted evening exercise may, therefore, be limited by increased hunger and compensatory energy intake.
Consuming a meal lower in carbohydrate and higher in protein and/or fat can increase rates of fat oxidation during exercise (Rowlands \& Hopkins, 2002; Oliviera et al., 2021). Protein is also the most satiating macronutrient, and high-protein diets are associated with reductions in energy intake. Consuming a high-protein pre-exercise meal compared to a typical high-carbohydrate meal also led to greater exercise-induced elevations in hormones typically associated with increased satiety and reduced hunger: peptide tyrosine-tyrosine (PYY) and glucagon-like peptide-1 (GLP-1) (Oliviera et al., 2021). Therefore, consuming a meal with a low carbohydrate content and higher protein content before exercise, rather than completely fasting, could be utilised to enhance the metabolic responses to exercise, whilst simultaneously managing appetite and subsequent energy intake. Further research is needed to fully understand the metabolic and appetite-related effects of a low-carbohydrate, higher-protein meal prior to exercise in the evening, compared to a typically consumed higher-carbohydrate meal and complete fasting.
- Conditions
- Obesity, Metabolic Syndrome
- Being tested
- Low-Carbohydrate Pre-Exercise Meal, High-Carbohydrate Pre-Exercise Meal, Fasted Exercise
- Keywords
- Fasted exercise, Low-carbohydrate, High-protein, Appetite, Energy Intake, Metabolism
- Medical subject headings
- Obesity, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-Carbohydrate Pre-Exercise MealBehavioural
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.
High-Carbohydrate Pre-Exercise MealBehavioural
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.
Fasted ExerciseBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Behavioral: Fasted Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Throughout the 60-minute steady-state bout of cycling
Secondary outcomes (17)
Voluntary energy intake (Kilocalories) at a laboratory-based test meal.
A laboratory-based dinner 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'.
Measured: 60 minutes following the end of the exercise session.
Visual Analogue Scale for Subjective Ratings of Appetite.
Time-course of subjective ratings of hunger between breakfast provision and one hour after consuming lunch, measured using an appetite visual analogue scale. The scale is divided into subscales of different appetite perceptions including: hunger, fullness, desire to eat and prospective food consumption. Each subscale is rated on a 100mm scale (i.e. from 0 - 100), with a rating of 100 fully supporting the perception and a rating of 0 fully opposing the perception.
Measured: Baseline, 1 hour, 1.75 hours, 2.75 hours, 3 hours, 3.5 hours (mid-exercise), 4 hours, 5 hours.
Acylated ghrelin
Time-course of acylated ghrelin plasma concentrations across experimental trials.
Measured: Baseline, 1 hour, 1.75 hours, 2.75 hours, 3 hours, 3.5 hours (mid-exercise), 4 hours, 5 hours.
Peptide tyrosine-tyrosine (PYY)
Time-course of PYY plasma concentrations across experimental trials.
Measured: 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)
Time-course of GLP-1 plasma concentrations across experimental trials.
Measured: Baseline, 1 hour, 1.75 hours, 2.75 hours, 3 hours, 3.5 hours (mid-exercise), 4 hours, 5 hours.
Glucose
Time-course of glucose plasma concentrations across experimental trials.
Measured: Baseline, 1 hour, 1.75 hours, 2.75 hours, 3 hours, 3.5 hours (mid-exercise), 4 hours, 5 hours.
Insulin
Time-course of insulin plasma concentrations across experimental trials.
Measured: Baseline, 1 hour, 1.75 hours, 2.75 hours, 3 hours, 3.5 hours (mid-exercise), 4 hours, 5 hours.
Non-esterified fatty-acids (NEFA)
Time-course of NEFA plasma concentrations across experimental trials.
Measured: Baseline, 1 hour, 1.75 hours, 2.75 hours, 3 hours, 3.5 hours (mid-exercise), 4 hours, 5 hours.
Glycerol
Time-course of glycerol plasma concentrations across experimental trials.
Measured: Baseline, 1 hour, 1.75 hours, 2.75 hours, 3 hours, 3.5 hours (mid-exercise), 4 hours, 5 hours.
Rating of Perceived Exertion (RPE).
RPE will be measured at 10-minute intervals throughout the 60-minute exercise period on a 6-20 RPE scale. The participant will point to the value that corresponds to their current perceived exertion (6 being no exertion at all; 20 being maximal exertion).
Measured: Throughout the 60-minute steady-state bout of cycling.
Pre-exercise Subjective Feelings.
A single questionnaire to assess pre-exercise subjective feelings will be measured using a visual analogue scale. The scale is divided into subscales of different feelings including: motivation, readiness, tiredness, nausea, and energetic. Each subscale is rated on a 100mm scale (i.e. from 0 - 100), with a rating of 100 fully supporting the perception and a rating of 0 fully opposing the perception.
Measured: Immediately before the exercise session.
Enjoyment of the Exercise Bout.
A shortened version of The Physical Activity Enjoyment Scale (PACES) will be completed to gauge enjoyment of the exercise sessions. A scale from 1-7 will be used for eight feelings. The participant will circle the value that corresponds to which (6 being no exertion at all; 20 being maximal exertion).
The scale is divided into bipolar subscales of different feelings including: enjoyment, liking, pleasure, fun, pleasantness, interest, engagement and task absorption . Each subscale is rated on a 1-7 bipolar scale (i.e. from 1 - 7), with a rating of 1 fully supporting the feeling on the left-hand side of the subscale, and a rating of 7 fully supporting the feeling on the right-hand side of the subscale. For three subscales, a positive feeling is placed at 7, and for four subscales, a negative feeling is placed at 7 (reverse scored).
Measured: Immediately following the end of the exercise session.
Carbohydrate Oxidation Rate During Steady-State Exercise
Measurements of VO2 and VCO2 during a 60 minute steady state bout of cycling to determine rates of carbohydrate oxidation
Measured: Throughout the 60-minute steady-state bout of cycling
Rate of Energy Expenditure During Steady-State Exercise
Measurements of VO2 and VCO2 during a 60 minute steady state bout of cycling to determine rates energy expenditure.
Measured: Throughout the 60-minute steady-state bout of cycling
Carbohydrate Oxidation Rate At Rest
Measurements of VO2 and VCO2 during at rest during experimental trials to determine rates of carbohydrate oxidation.
Measured: Baseline, 1 hour, 1.75 hours, 2.75 hours, 5 hours
Fat Oxidation Rate At Rest
Measurements of VO2 and VCO2 during at rest during experimental trials to determine rates of fat oxidation.
Measured: Baseline, 1 hour, 1.75 hours, 2.75 hours, 5 hours
Rate of Energy Expenditure At Rest
Measurements of VO2 and VCO2 during at rest during experimental trials to determine rates of energy expenditure.
Measured: Baseline, 1 hour, 1.75 hours, 2.75 hours, 5 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2021
- Study start1 Sep 2021
- Primary completion30 Jun 2022
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nottingham Trent University
- Sponsor type
- University, hospital or other
- Collaborators
- Loughborough University
- Responsible party
- Principal investigator, Tommy Slater, Nottingham Trent University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05107583
- Sponsor's protocol ID
- TS_PreExCHO_2021
- Status last verified
- Sep 2022
- First submitted
- 12 Aug 2021
- Last updated
- 14 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 31628477Van 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.
PubMed 20837645Edinburgh 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.
PubMed 31321428Bachman 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.
PubMed 27738523Rowlands 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.
PubMed 12037719Oliveira 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.
PubMed 33466462Kendzierski, 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.
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.
PubMed 33919779
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing the Effects of a High- and Low-carbohydrate Pre-exercise Meal Relative to Fasting on Exercise Metabolism, Subsequent Appetite, and Energy Intake in Healthy Males.
- ClinicalTrials.gov ID
- NCT05107583
- Acronym / sponsor ID
- TS_PreExCHO_2021
- Conditions
- Obesity, Metabolic Syndrome
- Keywords
- Fasted exercise, Low-carbohydrate, High-protein, Appetite, Energy Intake, Metabolism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Nottingham Trent UniversityUniversity, hospital or other
- Collaborators
- Loughborough University
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 4 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
Regular exercise is known to be a successful strategy for improving several facets of health and maintaining body weight. However, many people are not engaging in enough exercise, and some may not be achieving maximum benefits from the exercise that they already do. Performing exercise in the overnight fasted state has been shown to reduce energy intake over the course of a single day, without any compensatory reductions in free-living energy expenditure. Despite these promising findings, it is likely that not every member of the population is logistically able to perform exercise in the morning due to various work, family and social commitments, and exercise in the evening may be a logical alternative for these individuals.
Studies have found that exercise performed after an overnight fast may incur superior improvements in insulin sensitivity in lean individuals (Van Proeyen et al., 2010), and individuals with overweight or obesity (Edinburgh et al., 2020), compared to exercising after breakfast. These superior improvements may be mediated, in part, by an increased mobilisation and oxidation of endogenous lipid stores. Additionally, overnight fasted exercise may result in a more negative energy balance than exercising after breakfast (Bachman et al., 2016; Edinburgh et al., 2019). We recently examined whether exercise performed in the evening following an extended period of fasting (7 h) would induce similar responses to overnight fasted exercise regarding substrate oxidation patterns and subsequent energy intake (manuscript in preparation - NCT04742530). This research question was important, as we speculate that a large proportion of the population are likely unable to perform exercise in the morning after an overnight fast due to various logistical barriers. Therefore fasting prior to evening exercise could act as an alternative for these individuals.
We found that compared to consuming a carbohydrate-containing meal 2 h prior, fasting before evening exercise resulted in elevated fat oxidation rates during exercise, but was accompanied by compensatory eating at dinner. Additionally, participants reported that fasting throughout the afternoon was difficult. The long-term efficacy of fasted evening exercise may, therefore, be limited by increased hunger and compensatory energy intake.
Consuming a meal lower in carbohydrate and higher in protein and/or fat can increase rates of fat oxidation during exercise (Rowlands \& Hopkins, 2002; Oliviera et al., 2021). Protein is also the most satiating macronutrient, and high-protein diets are associated with reductions in energy intake. Consuming a high-protein pre-exercise meal compared to a typical high-carbohydrate meal also led to greater exercise-induced elevations in hormones typically associated with increased satiety and reduced hunger: peptide tyrosine-tyrosine (PYY) and glucagon-like peptide-1 (GLP-1) (Oliviera et al., 2021). Therefore, consuming a meal with a low carbohydrate content and higher protein content before exercise, rather than completely fasting, could be utilised to enhance the metabolic responses to exercise, whilst simultaneously managing appetite and subsequent energy intake. Further research is needed to fully understand the metabolic and appetite-related effects of a low-carbohydrate, higher-protein meal prior to exercise in the evening, compared to a typically consumed higher-carbohydrate meal and complete fasting.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Low-Carbohydrate Pre-Exercise Meal | Experimental | Behavioral: Low-Carbohydrate Pre-Exercise MealParticipants will consume a low-carbohydrate (<10% carbohydrate) lunch meal at 13:30 - 2.5 hours prior to commencing exercise at 16:00. |
| High-Carbohydrate Pre-Exercise Meal | Experimental | Behavioral: High-Carbohydrate Pre-Exercise MealParticipants 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. |
| Fasted Exercise | Experimental | Behavioral: Fasted ExerciseParticipants 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. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (6 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low-Carbohydrate Pre-Exercise MealSixty 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. | Behavioural | Low-Carbohydrate Pre-Exercise Meal |
| High-Carbohydrate Pre-Exercise MealSixty 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. | Behavioural | High-Carbohydrate Pre-Exercise Meal |
| Fasted ExerciseSixty 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. | Behavioural | Fasted Exercise |
Primary outcome
Fat Oxidation Rate During Steady-State Exercise.
Time frame: Throughout the 60-minute steady-state bout of cycling
Measurements of VO2 and VCO2 during a 60 minute steady state bout of cycling to determine rates of fat oxidation.
17 secondary outcomes
Voluntary energy intake (Kilocalories) at a laboratory-based test meal.
Time frame: 60 minutes following the end of the exercise session.
Visual Analogue Scale for Subjective Ratings of Appetite.
Time frame: Baseline, 1 hour, 1.75 hours, 2.75 hours, 3 hours, 3.5 hours (mid-exercise), 4 hours, 5 hours.
Acylated ghrelin
Time frame: Baseline, 1 hour, 1.75 hours, 2.75 hours, 3 hours, 3.5 hours (mid-exercise), 4 hours, 5 hours.
Peptide tyrosine-tyrosine (PYY)
Time frame: 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)
Time frame: Baseline, 1 hour, 1.75 hours, 2.75 hours, 3 hours, 3.5 hours (mid-exercise), 4 hours, 5 hours.
Glucose
Time frame: Baseline, 1 hour, 1.75 hours, 2.75 hours, 3 hours, 3.5 hours (mid-exercise), 4 hours, 5 hours.
Insulin
Time frame: Baseline, 1 hour, 1.75 hours, 2.75 hours, 3 hours, 3.5 hours (mid-exercise), 4 hours, 5 hours.
Non-esterified fatty-acids (NEFA)
Time frame: Baseline, 1 hour, 1.75 hours, 2.75 hours, 3 hours, 3.5 hours (mid-exercise), 4 hours, 5 hours.
Glycerol
Time frame: Baseline, 1 hour, 1.75 hours, 2.75 hours, 3 hours, 3.5 hours (mid-exercise), 4 hours, 5 hours.
Rating of Perceived Exertion (RPE).
Time frame: Throughout the 60-minute steady-state bout of cycling.
Pre-exercise Subjective Feelings.
Time frame: Immediately before the exercise session.
Enjoyment of the Exercise Bout.
Time frame: Immediately following the end of the exercise session.
Carbohydrate Oxidation Rate During Steady-State Exercise
Time frame: Throughout the 60-minute steady-state bout of cycling
Rate of Energy Expenditure During Steady-State Exercise
Time frame: Throughout the 60-minute steady-state bout of cycling
Carbohydrate Oxidation Rate At Rest
Time frame: Baseline, 1 hour, 1.75 hours, 2.75 hours, 5 hours
Fat Oxidation Rate At Rest
Time frame: Baseline, 1 hour, 1.75 hours, 2.75 hours, 5 hours
Rate of Energy Expenditure At Rest
Time frame: Baseline, 1 hour, 1.75 hours, 2.75 hours, 5 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2022.
- Background: PubMed 31628477Edinburgh 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.
- Background: PubMed 20837645Van 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.
- Background: PubMed 31321428Edinburgh 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.
- Background: PubMed 27738523Bachman 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.
- Background: PubMed 12037719Rowlands 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.
- Background: PubMed 33466462Oliveira 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.
- BackgroundKendzierski, 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: PubMed 33919779Rothschild 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low-Carbohydrate Pre-Exercise Meal, High-Carbohydrate Pre-Exercise Meal and Fasted Exercise in people with Obesity and Metabolic Syndrome, run by Nottingham Trent University at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fat Oxidation Rate During Steady-State Exercise. (time frame: Throughout the 60-minute steady-state bout of cycling). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05107583, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2022.