HealthyNCT04106752
Timing of Meal and Caffeine Intake on Substrate Use and Exercise Efficiency
A study testing Caffeine in people with Healthy, run by American University of Beirut Medical Center at 1 site in Lebanon.
Trial summary
During the past decades, considerable emphasis has been directed to analyzing the potential role of caffeine on substrate use and exercise performance. Research shows that caffeine ingestion prior to exercise has beneficial effects on submaximal exercise capacity and time trial protocols. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Caffeine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteLebanon
- Study dates
- 5 Mar 2018to 29 Jul 2019
- 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 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male or female individual between 18 and 30 years old,
- normal weight or overweight
Who cannot join
- Subjects will be excluded if they are not covered by (University health insurance) HIP,
- subjects with the previous history of any limitation on physical ability,
- Subjects with cardiovascular disease,
- Subjects taking supplements or medicine that might affect their metabolic rate,
- claustrophobic,
- Subjects with unstable body weight during the past 6 months.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Timing of Meal and Caffeine Intake on Substrate Use and Exercise Efficiency in Healthy Individuals
During the past decades, considerable emphasis has been directed to analyzing the potential role of caffeine on substrate use and exercise performance. Research shows that caffeine ingestion prior to exercise has beneficial effects on submaximal exercise capacity and time trial protocols. This effect is mediated by an increase in plasma free fatty acids and intramuscular triglyceride utilization, preserving muscle and liver glycogen. Generally, a dose between 4 - 9 mg/kg body mass is administered to athletes in order to observe a positive or ergogenic effect. Caffeine ingestion (6 mg/kg) improved exercise performance in a long duration protocol (2 hours + ~ 30 min time trial) regardless of the administration time (1 hour before or during exercise). Lower doses of caffeine (~ 1.5 mg/kg), when added to a carbohydrate solution increased exercise performance in a similar fashion. In rats, caffeine has been shown to have a biphasic action on postprandial glucose metabolism. When ingested before a meal, hepatic glycogenesis is blunted. Its ingestion during and after a meal allows glycogenesis to occur. Manipulating meal and caffeine timing before low intensity exercise, comparable to every-day life activities, is of great interest in assessing substrate use and muscular efficiency. it would be also interesting to see how this meal or caffeine timing manipulation influence the energetics of different phenotypes.
Read the detailed description
Research shows that caffeine ingestion prior to exercise has beneficial effects on moderate to high exercise performance. Generally, a dose between 4 - 9 mg/kg body mass is administered to athletes in order to observe a positive effect.
The aims of the study are the following: first, to investigate the effect of caffeine and/or meal on energy supply (% from fat and carbohydrate) during low intensity exercise. Second, to investigate the effect of timing and order of the above on energy supply before, during, and after exercise. Lastly, to assess exercise efficiency following the above protocols (work accomplished relative to the calories spent to accomplish the work).
Healthy, untrained male and female subjects will be recruited for this study. Subjects will be excluded if they had a previous history of any limitation on physical ability, cardiovascular disease, taking supplements or medicine that might affect their metabolic rate, claustrophobic, or unstable bodyweight during the past 6 months. Subjects will be defined as sedentary, with a maximum of 30 minutes of moderate physical activity per day (assessed by questionnaire) excluding daily activities.
During the first visit, participants will be informed about the experiment protocol, if agreed, they should give a written consent, answer a questionnaire (lifestyle), and get anthropometric and body composition measurements.
On the day of testing, subjects will come to the laboratory at 08:00 fasted. All participants will be requested to avoid physical activity, caffeine, and dietary supplements in the 24h prior to testing.
Energy expenditure is measured by indirect calorimetry. Briefly, participants will sit in a comfortable seat, using a ventilated hood with baseline energy expenditure. During this period, the participant is instructed to relax and avoid movements. Heart rate monitoring is included using a heart rate belt. Participants then complete the following protocols on five separate days (separated by at least 48 hours) in a randomized order:
Protocol 1:
A standardized meal (2 slices of toast bread + butter + Jam ~ 500 kcal) + caffeine (~200 mg) will be given to the participant. 2 hours later resting energy expenditure is measured using a facemask for 10 min while seated on a cycle ergometer. The participant will be asked to pedal at 60 revolutions per minute for 5 min per load at 20 watts (W), 35W, 50W, 65W, 80 W respectively.
Protocol 2:
A standardized meal will be given to the participant. 2 hours later caffeine will be given followed by the same protocol mentioned above.
Protocol 3:
Caffeine will be given to the participant. 2 hours later a standardized meal will be given followed by the same protocol mentioned above.
Protocol 4:
Caffeine will be given to the participant. 2 hours later the same protocol mentioned above will be applied.
Protocol 5:
A standardized meal will be given to the participant. 2 hours later the same protocol mentioned above will be applied.
Manipulating meal and caffeine timing before low intensity exercise, comparable to every-day life activities, is of great interest in assessing energy supply and muscular efficiency in humans.
There is no risks related to the study. Exercise is maintained at a low-to-moderate level comparable to everyday life. All data related to the subjects will be coded (# and initials, i.e. A001_ELIFAR) and kept confidential.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CaffeineDietary supplement
Provide caffeine supplements with or without meal before exercise
| Study group | Role | What they receive |
|---|---|---|
| meal followed by caffeine | Active comparator | A standardized meal consisting of 2 slices of toast bread, organic peanut butter and jam was given to the participant. One and a half hours later, the participant ingested a caffeinated drink (3 mg per kg body weight of caffeine powder dissolved in water). After 30 mins, resting EE was measured using FM for 15 min while seated on the comfortable seat, and then for 5 min while seated on a cycle ergometer. Participants were then asked to pedal at 60 revolutions per minute (rpm) for 5 min per load at 20 watts (W), 35W, 50W, 65W, 80 W respectively. During cycling, EE was being measured using the FM, HR was monitored and rating of perceived exertion (RPE) was recorded in the last minute of every load cycle. Receives: Dietary Supplement: Caffeine |
| Caffeine followed by meal | Active comparator | Caffeine was given to the participant. After 1.5 hours the standardized meal was given followed by the same protocol mentioned above. Receives: Dietary Supplement: Caffeine |
| caffeine only | Active comparator | Caffeine will be given to the participant. 2 hours later the same protocol mentioned above will be applied Receives: Dietary Supplement: Caffeine |
| Meal only | Active comparator | A standardized meal will be given to the participant. 2 hours later the same protocol mentioned above will be applied. Receives: Dietary Supplement: Caffeine |
| meal plus caffeine | Active comparator | A standardized meal + a caffeinated drink (3 mg/kg of body weight of caffeine powder dissolved in water) will be given to the participant. 2 hours later resting EE is measured using a facemask (FM) for 10 min while seated on a cycle ergometer . The participant will be asked to pedal at 60 revolutions per minute (rpm) for 5 min per load at 20 watts (W), 35W, 50W, 65W, 80 W respectively. Receives: Dietary Supplement: Caffeine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in respiratory quotion
Compare respiratory quotient (RQ) values (indicator of the substrate being used) during low level exercise after caffeine and/or meal intake
Measured: 24 months
Exercise efficiency
Calculate exercise efficiency (delta work/ delta energy) during different protocols. The more efficient the participant is the more work he or she can do with the same amount of energy
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2019
- Study start5 Mar 2018
- Primary completion30 Jun 2019
- Study completion29 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- American University of Beirut Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elie-Jacques Fares, PhD, Principal investigator, American University of Beirut Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04106752
- Sponsor's protocol ID
- NUT.EF.01
- Status last verified
- Jan 2019
- First submitted
- 12 Sep 2019
- Last updated
- 27 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Timing of Meal and Caffeine Intake on Substrate Use and Exercise Efficiency in Healthy Individuals
- ClinicalTrials.gov ID
- NCT04106752
- Acronym / sponsor ID
- NUT.EF.01
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- American University of Beirut Medical CenterUniversity, hospital or other
- Study start
- 5 Mar 2018 (actual)
- Primary completion
- 30 Jun 2019 (actual)
- Study completion
- 29 Jul 2019 (actual)
- First posted
- 27 Sep 2019 (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.
During the past decades, considerable emphasis has been directed to analyzing the potential role of caffeine on substrate use and exercise performance. Research shows that caffeine ingestion prior to exercise has beneficial effects on submaximal exercise capacity and time trial protocols. This effect is mediated by an increase in plasma free fatty acids and intramuscular triglyceride utilization, preserving muscle and liver glycogen. Generally, a dose between 4 - 9 mg/kg body mass is administered to athletes in order to observe a positive or ergogenic effect. Caffeine ingestion (6 mg/kg) improved exercise performance in a long duration protocol (2 hours + ~ 30 min time trial) regardless of the administration time (1 hour before or during exercise). Lower doses of caffeine (~ 1.5 mg/kg), when added to a carbohydrate solution increased exercise performance in a similar fashion. In rats, caffeine has been shown to have a biphasic action on postprandial glucose metabolism. When ingested before a meal, hepatic glycogenesis is blunted. Its ingestion during and after a meal allows glycogenesis to occur. Manipulating meal and caffeine timing before low intensity exercise, comparable to every-day life activities, is of great interest in assessing substrate use and muscular efficiency. it would be also interesting to see how this meal or caffeine timing manipulation influence the energetics of different phenotypes.
Detailed description
Research shows that caffeine ingestion prior to exercise has beneficial effects on moderate to high exercise performance. Generally, a dose between 4 - 9 mg/kg body mass is administered to athletes in order to observe a positive effect.
The aims of the study are the following: first, to investigate the effect of caffeine and/or meal on energy supply (% from fat and carbohydrate) during low intensity exercise. Second, to investigate the effect of timing and order of the above on energy supply before, during, and after exercise. Lastly, to assess exercise efficiency following the above protocols (work accomplished relative to the calories spent to accomplish the work).
Healthy, untrained male and female subjects will be recruited for this study. Subjects will be excluded if they had a previous history of any limitation on physical ability, cardiovascular disease, taking supplements or medicine that might affect their metabolic rate, claustrophobic, or unstable bodyweight during the past 6 months. Subjects will be defined as sedentary, with a maximum of 30 minutes of moderate physical activity per day (assessed by questionnaire) excluding daily activities.
During the first visit, participants will be informed about the experiment protocol, if agreed, they should give a written consent, answer a questionnaire (lifestyle), and get anthropometric and body composition measurements.
On the day of testing, subjects will come to the laboratory at 08:00 fasted. All participants will be requested to avoid physical activity, caffeine, and dietary supplements in the 24h prior to testing.
Energy expenditure is measured by indirect calorimetry. Briefly, participants will sit in a comfortable seat, using a ventilated hood with baseline energy expenditure. During this period, the participant is instructed to relax and avoid movements. Heart rate monitoring is included using a heart rate belt. Participants then complete the following protocols on five separate days (separated by at least 48 hours) in a randomized order:
Protocol 1:
A standardized meal (2 slices of toast bread + butter + Jam ~ 500 kcal) + caffeine (~200 mg) will be given to the participant. 2 hours later resting energy expenditure is measured using a facemask for 10 min while seated on a cycle ergometer. The participant will be asked to pedal at 60 revolutions per minute for 5 min per load at 20 watts (W), 35W, 50W, 65W, 80 W respectively.
Protocol 2:
A standardized meal will be given to the participant. 2 hours later caffeine will be given followed by the same protocol mentioned above.
Protocol 3:
Caffeine will be given to the participant. 2 hours later a standardized meal will be given followed by the same protocol mentioned above.
Protocol 4:
Caffeine will be given to the participant. 2 hours later the same protocol mentioned above will be applied.
Protocol 5:
A standardized meal will be given to the participant. 2 hours later the same protocol mentioned above will be applied.
Manipulating meal and caffeine timing before low intensity exercise, comparable to every-day life activities, is of great interest in assessing energy supply and muscular efficiency in humans.
There is no risks related to the study. Exercise is maintained at a low-to-moderate level comparable to everyday life. All data related to the subjects will be coded (# and initials, i.e. A001_ELIFAR) and kept confidential.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| meal followed by caffeine | Active comparator | Dietary Supplement: CaffeineA standardized meal consisting of 2 slices of toast bread, organic peanut butter and jam was given to the participant. One and a half hours later, the participant ingested a caffeinated drink (3 mg per kg body weight of caffeine powder dissolved in water). After 30 mins, resting EE was measured using FM for 15 min while seated on the comfortable seat, and then for 5 min while seated on a cycle ergometer. Participants were then asked to pedal at 60 revolutions per minute (rpm) for 5 min per load at 20 watts (W), 35W, 50W, 65W, 80 W respectively. During cycling, EE was being measured using the FM, HR was monitored and rating of perceived exertion (RPE) was recorded in the last minute of every load cycle. |
| Caffeine followed by meal | Active comparator | Dietary Supplement: CaffeineCaffeine was given to the participant. After 1.5 hours the standardized meal was given followed by the same protocol mentioned above. |
| caffeine only | Active comparator | Dietary Supplement: CaffeineCaffeine will be given to the participant. 2 hours later the same protocol mentioned above will be applied |
| Meal only | Active comparator | Dietary Supplement: CaffeineA standardized meal will be given to the participant. 2 hours later the same protocol mentioned above will be applied. |
| meal plus caffeine | Active comparator | Dietary Supplement: CaffeineA standardized meal + a caffeinated drink (3 mg/kg of body weight of caffeine powder dissolved in water) will be given to the participant. 2 hours later resting EE is measured using a facemask (FM) for 10 min while seated on a cycle ergometer . The participant will be asked to pedal at 60 revolutions per minute (rpm) for 5 min per load at 20 watts (W), 35W, 50W, 65W, 80 W respectively. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy male or female individual between 18 and 30 years old,
- normal weight or overweight
Key exclusion criteria (6 listed)
- Subjects will be excluded if they are not covered by (University health insurance) HIP,
- subjects with the previous history of any limitation on physical ability,
- Subjects with cardiovascular disease,
- Subjects taking supplements or medicine that might affect their metabolic rate,
- claustrophobic,
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 |
|---|---|---|
| CaffeineProvide caffeine supplements with or without meal before exercise | Dietary supplement | Caffeine followed by meal, Meal only, caffeine only, meal followed by caffeine, meal plus caffeine |
Primary outcome
Changes in respiratory quotion
Time frame: 24 months
Compare respiratory quotient (RQ) values (indicator of the substrate being used) during low level exercise after caffeine and/or meal intake
Exercise efficiency
Time frame: 24 months
Calculate exercise efficiency (delta work/ delta energy) during different protocols. The more efficient the participant is the more work he or she can do with the same amount of energy
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 27 Sep 2019.
- Individual participant dataSharing planned: No
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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.
Elie-Jacques Fares, PhD principal investigator
American University of Beirut Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Caffeine in people with Healthy, run by American University of Beirut Medical Center at 1 site in Lebanon.
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 2 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 27 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Lebanon. 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?
Changes in respiratory quotion (time frame: 24 months). 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?
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 27 Sep 2019; AzTrials last refreshed its copy on 7 Nov 2026.