Trial Outcomes & Findings for Effect of Oral Caffeine and L-Citrulline Supplementation on Arterial Function in Healthy Males (NCT NCT02214290)
NCT ID: NCT02214290
Last Updated: 2020-12-29
Results Overview
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.
COMPLETED
NA
16 participants
Baseline and Day 7 (Calculated change between rest and 30 minutes post-caffeine ingestion at these time points)
2020-12-29
Participant Flow
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.
Of the 42 individuals screened, 16 individuals completed the intervention in its entirety.
Participant milestones
| Measure |
Citrulline First, Then Placebo
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.
|
Placebo First, Then L-Citrulline
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.
|
|---|---|---|
|
First Intervention (7 Days)
STARTED
|
8
|
8
|
|
First Intervention (7 Days)
COMPLETED
|
8
|
8
|
|
First Intervention (7 Days)
NOT COMPLETED
|
0
|
0
|
|
Washout (14 Days)
STARTED
|
8
|
8
|
|
Washout (14 Days)
COMPLETED
|
8
|
8
|
|
Washout (14 Days)
NOT COMPLETED
|
0
|
0
|
|
Second Intervention (7 Days)
STARTED
|
8
|
8
|
|
Second Intervention (7 Days)
COMPLETED
|
8
|
8
|
|
Second Intervention (7 Days)
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
L-Citrulline or Placebo
n=16 Participants
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.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=16 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
16 Participants
n=16 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=16 Participants
|
|
Age, Continuous
|
23 years
STANDARD_DEVIATION 3 • n=16 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=16 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=16 Participants
|
PRIMARY outcome
Timeframe: Baseline and Day 7 (Calculated change between rest and 30 minutes post-caffeine ingestion at these time points)Population: Young, apparently healthy individuals, aged 18-40 years old.
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.
Outcome measures
| Measure |
Citrulline
n=16 Participants
Participants received 6g/day of Citrulline for 7 days
|
Placebo
n=16 Participants
Participants received 6 g/day of Maltodextrin for 7 days.
|
|---|---|---|
|
Aortic Blood Pressure
Baseline
|
5 mmHg
Standard Deviation 1
|
6 mmHg
Standard Deviation 1
|
|
Aortic Blood Pressure
7 Days
|
4 mmHg
Standard Deviation 1
|
4 mmHg
Standard Deviation 1
|
SECONDARY outcome
Timeframe: Baseline and Day 7 (Calculated change between rest and 30 minutes post-caffeine ingestion at these time points)Population: Young, apparently healthy adults, aged 18-40 years.
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.
Outcome measures
| Measure |
Citrulline
n=16 Participants
Participants received 6g/day of Citrulline for 7 days
|
Placebo
n=16 Participants
Participants received 6 g/day of Maltodextrin for 7 days.
|
|---|---|---|
|
Changes in Reflected Wave Pressure (P2)
Baseline
|
5 mmHg
Standard Deviation 1
|
5 mmHg
Standard Deviation 1
|
|
Changes in Reflected Wave Pressure (P2)
7 Days
|
4 mmHg
Standard Deviation 1
|
5 mmHg
Standard Deviation 1
|
SECONDARY outcome
Timeframe: Baseline and Day 7 (Calculated change between rest and 30 minutes post-caffeine ingestion at these time points)Population: young, apparently healthy adults, aged 18-40 years
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.
Outcome measures
| Measure |
Citrulline
n=16 Participants
Participants received 6g/day of Citrulline for 7 days
|
Placebo
n=16 Participants
Participants received 6 g/day of Maltodextrin for 7 days.
|
|---|---|---|
|
Changes in Femoral-ankle Pulse Wave Velocity After 7 Days of Either L-Citrulline or Placebo (6g/Day)
Baseline
|
0.6 m/s
Standard Deviation 0.4
|
0.7 m/s
Standard Deviation 0.5
|
|
Changes in Femoral-ankle Pulse Wave Velocity After 7 Days of Either L-Citrulline or Placebo (6g/Day)
7 Days
|
0.4 m/s
Standard Deviation 0.4
|
0.6 m/s
Standard Deviation 0.4
|
Adverse Events
Citrulline
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place