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Trial Outcomes & Findings for Effect of L-Arginine and Pycnogenol on Light to Moderate Hypertension and Endothelial Function (NCT NCT02392767)

NCT ID: NCT02392767

Last Updated: 2016-05-02

Results Overview

Endothelial function was determined with the EndoPAT™ method (non-invasive Peripheral Aterial Tonometry) using a reactive hyperemia procedure. The outcome measure is the change in endothelial function between the visit at start of the supplementation phase and the visit on the final day of the 4 week supplementation phase. The endothelial function is determined as the natural log of the Reactive Hyperemia Index ("lnRHI") which is the post-to-pre occlusion peripheral arterial tonometry signal ratio in the occluded side, relative to the same ratio in the control side, corrected for baseline vascular tone of the occluded side. Normal lnRHI \> 0.51, Abnormal lnRHI \< 0.51

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

25 participants

Primary outcome timeframe

Intervention period of 4 weeks

Results posted on

2016-05-02

Participant Flow

Cross-over study

Participant milestones

Participant milestones
Measure
First Verum, Then Placebo
2 times a day 2 verum tablets for 4 weeks. 8 weeks wash out. Then 2 times a day 2 placebo tablets for 4 weeks.
First Placebo, Then Verum
2 times a day 2 placebo tablets for 4 weeks. 8 weeks wash out. Then 2 times a day 2 verum tablets for 4 weeks.
Overall Study
STARTED
12
13
Overall Study
COMPLETED
12
13
Overall Study
NOT COMPLETED
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effect of L-Arginine and Pycnogenol on Light to Moderate Hypertension and Endothelial Function

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
First Verum, Then Placebo
n=12 Participants
2 times a day 2 verum tablets for 4 weeks. 8 weeks wash out. Then 2 times a day 2 placebo tablets for 4 weeks.
First Placebo, Then Verum
n=13 Participants
2 times a day 2 placebo tablets for 4 weeks. 8 weeks wash out. Then 2 times a day 2 verum tablets for 4 weeks.
Total
n=25 Participants
Total of all reporting groups
Age, Categorical
<=18 years
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Age, Categorical
Between 18 and 65 years
12 Participants
n=5 Participants
13 Participants
n=7 Participants
25 Participants
n=5 Participants
Age, Categorical
>=65 years
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Sex: Female, Male
Female
3 Participants
n=5 Participants
4 Participants
n=7 Participants
7 Participants
n=5 Participants
Sex: Female, Male
Male
9 Participants
n=5 Participants
9 Participants
n=7 Participants
18 Participants
n=5 Participants
Region of Enrollment
Germany
12 participants
n=5 Participants
13 participants
n=7 Participants
25 participants
n=5 Participants

PRIMARY outcome

Timeframe: Intervention period of 4 weeks

Endothelial function was determined with the EndoPAT™ method (non-invasive Peripheral Aterial Tonometry) using a reactive hyperemia procedure. The outcome measure is the change in endothelial function between the visit at start of the supplementation phase and the visit on the final day of the 4 week supplementation phase. The endothelial function is determined as the natural log of the Reactive Hyperemia Index ("lnRHI") which is the post-to-pre occlusion peripheral arterial tonometry signal ratio in the occluded side, relative to the same ratio in the control side, corrected for baseline vascular tone of the occluded side. Normal lnRHI \> 0.51, Abnormal lnRHI \< 0.51

Outcome measures

Outcome measures
Measure
Verum
n=25 Participants
2 times 2 tablets a day for 4 weeks. Verum: 2400 mg L-arginine, 80 mg Pycnogenol, 45µg vitamine K2, 10 mg R (+) alpha lipoic acid, 8 mg vitamine B6, 500 µg vitamine B12, and 600 mg folic acid.
Placebo
n=25 Participants
2 times 2 tablets a day for 4 weeks. Placebo: corn starch
Change in Endothelial Function Between the Visit at Start of Supplementation Phase and the Visit on the Final Day of the 4 Week Supplementation Phase (Delta "lnRHI")
0.070 Delta lnRHI [Index]
Interval -0.065 to 0.205
-0.052 Delta lnRHI [Index]
Interval -0.163 to 0.06

SECONDARY outcome

Timeframe: Intervention period of 4 weeks

The mean of daily systolic and diastolic blood pressure measured daily at the last 7 days of the 4 week intervention period. Measurements were performed by subjects at home and were taken on the left arm, after at least 10 minutes of rest, in a sitting position.

Outcome measures

Outcome measures
Measure
Verum
n=25 Participants
2 times 2 tablets a day for 4 weeks. Verum: 2400 mg L-arginine, 80 mg Pycnogenol, 45µg vitamine K2, 10 mg R (+) alpha lipoic acid, 8 mg vitamine B6, 500 µg vitamine B12, and 600 mg folic acid.
Placebo
n=25 Participants
2 times 2 tablets a day for 4 weeks. Placebo: corn starch
Mean of Blood Pressure Measured Daily at the Last 7 Days of the 4 Week Intervention Period.
systolic reading
132.8 mmHg
Interval 129.1 to 136.6
133.2 mmHg
Interval 130.4 to 136.1
Mean of Blood Pressure Measured Daily at the Last 7 Days of the 4 Week Intervention Period.
diastolic reading
82.2 mmHg
Interval 79.8 to 84.6
83.5 mmHg
Interval 81.7 to 85.3

SECONDARY outcome

Timeframe: After intervention period of 4 weeks

Homocystein level in µmol/l was determined on the final day of the 4 week intervention period. The first supplementation period started at visit one and lasted for 4 weeks. It was followed by a wash out phase of 8 weeks and subsequently by a second supplementation phase of 4 weeks (cross-over design)

Outcome measures

Outcome measures
Measure
Verum
n=25 Participants
2 times 2 tablets a day for 4 weeks. Verum: 2400 mg L-arginine, 80 mg Pycnogenol, 45µg vitamine K2, 10 mg R (+) alpha lipoic acid, 8 mg vitamine B6, 500 µg vitamine B12, and 600 mg folic acid.
Placebo
n=25 Participants
2 times 2 tablets a day for 4 weeks. Placebo: corn starch
Homocystein Level Determined on the Final Day of the 4 Week Intervention Period.
9.10 μmol/l
Interval 8.3 to 9.9
11.95 μmol/l
Interval 11.19 to 12.72

SECONDARY outcome

Timeframe: After intervention period of 4 weeks

ADMA (asymmetric dimethyl arginine) was determined on the final day of the 4 week intervention period. Samples were analyzed batch wise using an enzymatic test

Outcome measures

Outcome measures
Measure
Verum
n=25 Participants
2 times 2 tablets a day for 4 weeks. Verum: 2400 mg L-arginine, 80 mg Pycnogenol, 45µg vitamine K2, 10 mg R (+) alpha lipoic acid, 8 mg vitamine B6, 500 µg vitamine B12, and 600 mg folic acid.
Placebo
n=25 Participants
2 times 2 tablets a day for 4 weeks. Placebo: corn starch
Asymmetric Dimethyl Arginine (ADMA) Level Determined on the Final Day of the 4 Week Intervention Period.
0.638 µmol/l
Interval 0.594 to 0.682
0.632 µmol/l
Interval 0.596 to 0.668

SECONDARY outcome

Timeframe: After intervention period of 4 weeks

Glycated hemoglobin (HbA1c) as percentage of total hemoglobin was determined on the final day of the 4 week intervention period.

Outcome measures

Outcome measures
Measure
Verum
n=25 Participants
2 times 2 tablets a day for 4 weeks. Verum: 2400 mg L-arginine, 80 mg Pycnogenol, 45µg vitamine K2, 10 mg R (+) alpha lipoic acid, 8 mg vitamine B6, 500 µg vitamine B12, and 600 mg folic acid.
Placebo
n=25 Participants
2 times 2 tablets a day for 4 weeks. Placebo: corn starch
Glycated Hemoglobin (HbA1c) Determined on the Final Day of the 4 Week Intervention Period.
5.37 percentage of total hemoglobin
Interval 5.2 to 5.54
5.34 percentage of total hemoglobin
Interval 5.19 to 5.5

OTHER_PRE_SPECIFIED outcome

Timeframe: Intervention period of 4 weeks

Prothrombin Time was assessed at the visit at start of the supplementation phase and the visit at the end of the 4 week supplementation phase. Blood coagulability is expressed in units of Quick value. In this case, the measured prothrombin time is expressed in relation to the coagulation time of a healthy person. The value obtained is the "percentage of the standard Quick value". In a person not receiving oral anticoagulation the "normal" Quick value is between 70 and 100%. The longer the patient's coagulation time, the lower the Quick value

Outcome measures

Outcome measures
Measure
Verum
n=25 Participants
2 times 2 tablets a day for 4 weeks. Verum: 2400 mg L-arginine, 80 mg Pycnogenol, 45µg vitamine K2, 10 mg R (+) alpha lipoic acid, 8 mg vitamine B6, 500 µg vitamine B12, and 600 mg folic acid.
Placebo
n=25 Participants
2 times 2 tablets a day for 4 weeks. Placebo: corn starch
Change in Prothrombin Time Between the Visit at Start of Supplementation Phase and the Visit on the Final Day of the 4 Week Supplementation Phase
2.00 Percentage of the standard Quick value
Interval -0.54 to 4.54
1.50 Percentage of the standard Quick value
Interval -1.31 to 4.31

Adverse Events

Verum

Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths

Placebo

Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure
Verum
n=25 participants at risk
2 times 2 tablets a day for 4 weeks. Verum: 2400 mg L-arginine, 80 mg Pycnogenol, 45µg vitamine K2, 10 mg R (+) alpha lipoic acid, 8 mg vitamine B6, 500 µg vitamine B12, and 600 mg folic acid.
Placebo
n=25 participants at risk
2 times 2 tablets a day for 4 weeks. Placebo: corn starch
Gastrointestinal disorders
diarrhoea
0.00%
0/25 • 4 weeks
4.0%
1/25 • Number of events 1 • 4 weeks
Infections and infestations
cold
8.0%
2/25 • Number of events 2 • 4 weeks
4.0%
1/25 • Number of events 1 • 4 weeks
Nervous system disorders
headache
8.0%
2/25 • Number of events 2 • 4 weeks
8.0%
2/25 • Number of events 3 • 4 weeks
Gastrointestinal disorders
malaise
0.00%
0/25 • 4 weeks
4.0%
1/25 • Number of events 1 • 4 weeks
Surgical and medical procedures
nasal mucosa disorder
0.00%
0/25 • 4 weeks
4.0%
1/25 • Number of events 1 • 4 weeks
Gastrointestinal disorders
loose stools
0.00%
0/25 • 4 weeks
4.0%
1/25 • Number of events 1 • 4 weeks
Infections and infestations
herpes NOS
0.00%
0/25 • 4 weeks
4.0%
1/25 • Number of events 1 • 4 weeks
Infections and infestations
febrile infection
0.00%
0/25 • 4 weeks
12.0%
3/25 • Number of events 3 • 4 weeks
Gastrointestinal disorders
gastrointestinal infection
0.00%
0/25 • 4 weeks
4.0%
1/25 • Number of events 1 • 4 weeks
Musculoskeletal and connective tissue disorders
lumbago
4.0%
1/25 • Number of events 1 • 4 weeks
0.00%
0/25 • 4 weeks
Musculoskeletal and connective tissue disorders
generalized aching
4.0%
1/25 • Number of events 1 • 4 weeks
0.00%
0/25 • 4 weeks
Skin and subcutaneous tissue disorders
skin rash
4.0%
1/25 • Number of events 1 • 4 weeks
0.00%
0/25 • 4 weeks
Renal and urinary disorders
bladder infection
4.0%
1/25 • Number of events 1 • 4 weeks
0.00%
0/25 • 4 weeks
Injury, poisoning and procedural complications
cycling accident
4.0%
1/25 • Number of events 1 • 4 weeks
0.00%
0/25 • 4 weeks

Additional Information

Dr. Birgit Goyvaerts

Dr. Loges + Co. GmbH

Phone: 0049-4171-707182

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place