Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Effect of Oral Caffeine and L-Citrulline Supplementation on Arterial Function in Healthy Males

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02214290
Recruitment Status : Completed
First Posted : August 12, 2014
Results First Posted : December 29, 2020
Last Update Posted : December 29, 2020
Sponsor:
Information provided by (Responsible Party):
Arturo Figueroa, Florida State University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Double (Participant, Outcomes Assessor);   Primary Purpose: Other
Conditions Hypertension
Healthy
Interventions Drug: Caffeine
Drug: Placebo
Dietary Supplement: L-citrulline
Enrollment 16
Recruitment Details Sixteen young healthy men participated in this study. All subjects were non-smokers, recreationally active, and free of apparent cardiovascular-metabolic diseases based on medical history.
Pre-assignment Details Of the 42 individuals screened, 16 individuals completed the intervention in its entirety.
Arm/Group Title Citrulline First, Then Placebo Placebo First, Then L-Citrulline
Hide Arm/Group Description Each participant received L-Citrulline (6g/day) for a 7 day period. This was followed by a 14 day washout period. Finally, the same participants then received a Placebo (6g/day maltodextrin) for a 7 day period. Each participant received a Placebo (6g/day maltodextrin) for a 7 day period. This was followed by a 14 day washout period. Finally, the same participants then received a L-Citrulline (6g/day) for a 7 day period.
Period Title: First Intervention (7 Days)
Started 8 8
Completed 8 8
Not Completed 0 0
Period Title: Washout (14 Days)
Started 8 8
Completed 8 8
Not Completed 0 0
Period Title: Second Intervention (7 Days)
Started 8 8
Completed 8 8
Not Completed 0 0
Arm/Group Title L-Citrulline or Placebo
Hide Arm/Group Description

Placebo and L-Citrulline pills produced by NOW FOODS, USA

Citrulline or Placebo (both 6g/day) were given for a 7 day supplementation period. This was followed by a 14 day washout period and crossover to the other supplement (L-Citrulline or Placebo) for 7 days. Measurements of arterial function were performed to determine if the supplements had any significant effect on blood pressure control/pressure wave reflection at rest and immediately after ingestion of 200 milligrams of caffeine.
Overall Number of Baseline Participants 16
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants
<=18 years
0
   0.0%
Between 18 and 65 years
16
 100.0%
>=65 years
0
   0.0%
Age, Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 16 participants
23  (3)
[1]
Measure Description: ages of 18 to 40 years
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants
Female
0
   0.0%
Male
16
 100.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants
Female
0
   0.0%
Male
16
 100.0%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
1.Primary Outcome
Title Aortic Blood Pressure
Hide Description Aortic blood pressure at rest and 30 minutes after acute ingestion of 200 mg of caffeine before and after 7 days of either 6g/day of Citrulline or 6 g/day of Placebo.
Time Frame Baseline and Day 7 (Calculated change between rest and 30 minutes post-caffeine ingestion at these time points)
Hide Outcome Measure Data
Hide Analysis Population Description
Young, apparently healthy individuals, aged 18-40 years old.
Arm/Group Title Citrulline Placebo
Hide Arm/Group Description:
Participants received 6g/day of Citrulline for 7 days
Participants received 6 g/day of Maltodextrin for 7 days.
Overall Number of Participants Analyzed 16 16
Mean (Standard Deviation)
Unit of Measure: mmHg
Baseline 5  (1) 6  (1)
7 Days 4  (1) 4  (1)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Citrulline, Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANOVA
Comments post-hoc comparisons were used to determine within-group and between-group differences.
2.Secondary Outcome
Title Changes in Reflected Wave Pressure (P2)
Hide Description Reflected wave pressure at rest and 30 minutes after ingestion of 200mg of caffeine after 7 days supplementation of 6g/day of either L-Citrulline or Placebo.
Time Frame Baseline and Day 7 (Calculated change between rest and 30 minutes post-caffeine ingestion at these time points)
Hide Outcome Measure Data
Hide Analysis Population Description
Young, apparently healthy adults, aged 18-40 years.
Arm/Group Title Citrulline Placebo
Hide Arm/Group Description:
Participants received 6g/day of Citrulline for 7 days
Participants received 6 g/day of Placebo
Overall Number of Participants Analyzed 16 16
Mean (Standard Deviation)
Unit of Measure: mmHg
Baseline 5  (1) 5  (1)
7 Days 4  (1) 5  (1)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Citrulline, Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANOVA
Comments post-hoc comparisons were used to determine within-group and between-group differences.
3.Secondary Outcome
Title Changes in Femoral-ankle Pulse Wave Velocity After 7 Days of Either L-Citrulline or Placebo (6g/Day)
Hide Description Femoral-ankle pulse wave velocity at rest and 30 minutes after ingestion of 200mg of caffeine after 7 days supplementation of 6g/day of either L-Citrulline or Placebo.
Time Frame Baseline and Day 7 (Calculated change between rest and 30 minutes post-caffeine ingestion at these time points)
Hide Outcome Measure Data
Hide Analysis Population Description
young, apparently healthy adults, aged 18-40 years
Arm/Group Title Citrulline Placebo
Hide Arm/Group Description:
Participants received a 6 g/day of Citrulline for 7 days
Participants received a 200 mg maltodextrin tablet, and femoral-ankle pulse wave velocity was taken at 60 minutes post-ingestion.
Overall Number of Participants Analyzed 16 16
Mean (Standard Deviation)
Unit of Measure: m/s
Baseline 0.6  (0.4) 0.7  (0.5)
7 Days 0.4  (0.4) 0.6  (0.4)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Citrulline, Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANOVA
Comments post-hoc comparisons were used to determine within-group and between-group differences.
Time Frame [Not Specified]
Adverse Event Reporting Description Adverse events were not monitored/assessed because the participants were young and healthy.
 
Arm/Group Title Citrulline Placebo
Hide Arm/Group Description Participants received 6g/day of Citrulline for 7 days Participants received 6g/day of Placebo (Maltodextrin) for 7 days
All-Cause Mortality
Citrulline Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
Hide Serious Adverse Events
Citrulline Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Citrulline Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
[Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Arturo Figueroa
Organization: Texas Tech University
Phone: 8068345587
EMail: arturo.figueroa@ttu.edu
Layout table for additonal information
Responsible Party: Arturo Figueroa, Florida State University
ClinicalTrials.gov Identifier: NCT02214290    
Other Study ID Numbers: HSC2013.10514
First Submitted: August 4, 2014
First Posted: August 12, 2014
Results First Submitted: November 30, 2018
Results First Posted: December 29, 2020
Last Update Posted: December 29, 2020