NCT04106752

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
8

participants targeted

Target at below P25 for not_applicable healthy

Timeline
Completed

Started Mar 2018

Typical duration for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 5, 2018

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2019

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 29, 2019

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 12, 2019

Completed
15 days until next milestone

First Posted

Study publicly available on registry

September 27, 2019

Completed
Last Updated

September 27, 2019

Status Verified

January 1, 2019

Enrollment Period

1.3 years

First QC Date

September 12, 2019

Last Update Submit

September 26, 2019

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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

    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

    24 months

Study Arms (5)

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.

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.

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

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.

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.

Dietary Supplement: Caffeine

Interventions

CaffeineDIETARY_SUPPLEMENT

Provide caffeine supplements with or without meal before exercise

Caffeine followed by mealMeal onlycaffeine onlymeal followed by caffeinemeal plus caffeine

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy male or female individual between 18 and 30 years old,
  • normal weight or overweight

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

American University of Beirut

Beirut, 1107 2020, Lebanon

Location

MeSH Terms

Interventions

Caffeine

Intervention Hierarchy (Ancestors)

XanthinesAlkaloidsHeterocyclic CompoundsPurinonesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Elie-Jacques Fares, PhD

    American University of Beirut Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 12, 2019

First Posted

September 27, 2019

Study Start

March 5, 2018

Primary Completion

June 30, 2019

Study Completion

July 29, 2019

Last Updated

September 27, 2019

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will not share

Locations