ObesityNCT04742530
Fasted Evening Exercise: Performance and Compensatory Eating
A study testing Fasted Evening Exercise, Fed Evening Exercise and Fed Morning Exercise in people with Obesity, run by Nottingham Trent University at 2 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Fasted Evening Exercise, Fed Evening Exercise and Fed Morning Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 8 Feb 2021to 23 Jun 2021
- 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
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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).
Who cannot join
- 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).
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- 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.
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Loughborough University
Loughborough, LE11 3TU
Nottingham Trent University
Nottingham, NG11 8NS
About this study
Official title: Effects of Extended Fasting Prior to Evening Exercise on Appetite, Energy Intake and Performance.
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.
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. Whether the beneficial effects of overnight fasted exercise can be observed at an alternative time of the day (i.e. the evening) is unknown.
Therefore, the investigators are interested in examining the compensatory appetite and energy intake responses following a bout of evening exercise performed after an extended (7 hour) period of fasting. Exercise performance will also be assessed as a marker of voluntary energy expenditure, which if reduced, has the potential to compensate for the reduced energy balance induced by fasted exercise.
- Conditions
- Obesity
- Being tested
- Fasted Evening Exercise, Fed Evening Exercise, Fed Morning Exercise
- Keywords
- Fasted exercise, Energy intake, Energy balance, Appetite, Exercise performance
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fasted Evening ExerciseBehavioural
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.
Fed Evening ExerciseBehavioural
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 Morning ExerciseBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Fasted Evening Exercise | Experimental | Exercise will take place in the evening, following a 7 hour period of fasting. Receives: 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. Receives: 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. Receives: Behavioral: Fed Morning Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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'.
Measured: 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.
Measured: Within the 15-minute performance test component of the exercise session.
Secondary outcomes (5)
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, 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.
Measurements of VO2 and VCO2 during a 30 minute steady state bout of cycling which precedes the 15-minute performance test.
Measured: Within the 30-minute steady-state component of the exercise session.
Rating of Perceived Exertion (RPE).
RPE will be measured at 5-minute intervals throughout the 45-minute exercise period (30 min steady state; 15 min performance test) 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: Within the 45-minute 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.
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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2021
- Study start8 Feb 2021
- Primary completion23 Jun 2021
- Study completion23 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)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
- None (open label)
- Enrolment
- 16 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
- NCT04742530
- Sponsor's protocol ID
- TS_FastEvEx_2021
- Status last verified
- Aug 2021
- First submitted
- 27 Jan 2021
- Last updated
- 5 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
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 27738523Clayton 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.
PubMed 25970668McIver 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.
PubMed 31445052James 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.
PubMed 28637708Metcalfe 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.
PubMed 32674691Maffucci 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.
PubMed 10861332Wallis 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.
PubMed 30334499Kendzierski, 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.
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
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.
PubMed 36539157
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Extended Fasting Prior to Evening Exercise on Appetite, Energy Intake and Performance.
- ClinicalTrials.gov ID
- NCT04742530
- Acronym / sponsor ID
- TS_FastEvEx_2021
- Conditions
- Obesity
- Keywords
- Fasted exercise, Energy intake, Energy balance, Appetite, Exercise performance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Nottingham Trent UniversityUniversity, hospital or other
- Collaborators
- Loughborough University
- Study start
- 8 Feb 2021 (actual)
- Primary completion
- 23 Jun 2021 (actual)
- Study completion
- 23 Jun 2021 (actual)
- First posted
- 8 Feb 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 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.
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. Whether the beneficial effects of overnight fasted exercise can be observed at an alternative time of the day (i.e. the evening) is unknown.
Therefore, the investigators are interested in examining the compensatory appetite and energy intake responses following a bout of evening exercise performed after an extended (7 hour) period of fasting. Exercise performance will also be assessed as a marker of voluntary energy expenditure, which if reduced, has the potential to compensate for the reduced energy balance induced by fasted exercise.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- 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 |
|---|---|---|
| Fasted Evening Exercise | Experimental | Behavioral: Fasted Evening ExerciseExercise will take place in the evening, following a 7 hour period of fasting. |
| Fed Evening Exercise | Active comparator | Behavioral: Fed Evening ExerciseExercise will take place in the evening, after having consumed a carbohydrate-containing meal 2 hours prior. |
| Fed Morning Exercise | Active comparator | Behavioral: Fed Morning ExerciseExercise will take place in the morning, after having consumed a carbohydrate-containing meal 2 hours prior. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (9 listed)
- 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.
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 |
|---|---|---|
| Fasted Evening ExerciseA 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. | Behavioural | Fasted Evening Exercise |
| Fed Evening ExerciseA 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. | Behavioural | Fed Evening Exercise |
| Fed Morning ExerciseA 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. | Behavioural | Fed Morning Exercise |
Primary outcome
Voluntary energy intake (Kilocalories) at a laboratory-based test meal
Time frame: 15 minutes following the end of the exercise session.
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'.
Exercise Performance (Voluntary Energy Expenditure)
Time frame: Within the 15-minute performance test component of the exercise session.
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.
5 secondary outcomes
Visual Analogue Scale for Subjective Ratings of Appetite
Time frame: 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.
Time frame: Within the 30-minute steady-state component of the exercise session.
Rating of Perceived Exertion (RPE).
Time frame: Within the 45-minute exercise session.
Enjoyment of the Exercise Bout
Time frame: Immediately following the end of the exercise session.
Pre-exercise Subjective Feelings
Time frame: Immediately before the exercise session.
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 5 Aug 2021.
- 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 25970668Clayton 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.
- Background: PubMed 31445052McIver 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.
- Background: PubMed 28637708James 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.
- Background: PubMed 32674691Metcalfe 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.
- Background: PubMed 10861332Maffucci 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.
- Background: PubMed 30334499Wallis 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.
- 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.
- BackgroundRaedeke, 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
- Derived from this study: PubMed 36539157Mode 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.
- 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 Fasted Evening Exercise, Fed Evening Exercise and Fed Morning Exercise in people with Obesity, 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 9 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 5 Aug 2021. 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?
Voluntary energy intake (Kilocalories) at a laboratory-based test meal (time frame: 15 minutes following the end of the exercise session.). The study lists 2 primary outcomes in all. 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 NCT04742530, which also lists 11 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 5 Aug 2021.