- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04106752
Timing of Meal and Caffeine Intake on Substrate Use and Exercise Efficiency
Timing of Meal and Caffeine Intake on Substrate Use and Exercise Efficiency in Healthy Individuals
Study Overview
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Beirut, Lebanon, 1107 2020
- American University of Beirut
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Healthy male or female individual between 18 and 30 years old,
- normal weight or overweight
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: meal followed by caffeine
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.
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Provide caffeine supplements with or without meal before exercise
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Active Comparator: Caffeine followed by meal
Caffeine was given to the participant.
After 1.5 hours the standardized meal was given followed by the same protocol mentioned above.
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Provide caffeine supplements with or without meal before exercise
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Active Comparator: caffeine only
Caffeine will be given to the participant.
2 hours later the same protocol mentioned above will be applied
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Provide caffeine supplements with or without meal before exercise
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Active Comparator: Meal only
A standardized meal will be given to the participant.
2 hours later the same protocol mentioned above will be applied.
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Provide caffeine supplements with or without meal before exercise
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Active Comparator: meal plus caffeine
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.
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Provide caffeine supplements with or without meal before exercise
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in respiratory quotion
Time Frame: 24 months
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Compare respiratory quotient (RQ) values (indicator of the substrate being used) during low level exercise after caffeine and/or meal intake
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24 months
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Exercise efficiency
Time Frame: 24 months
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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
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24 months
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Collaborators and Investigators
Investigators
- Principal Investigator: Elie-Jacques Fares, PhD, American University of Beirut Medical Center
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NUT.EF.01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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