Trial Outcomes & Findings for The Chronic Effects of Beetroot Juice in Hypertensive Subjects (NCT NCT01405898)

NCT ID: NCT01405898

Last Updated: 2016-01-08

Results Overview

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 68 participants
• Primary outcome timeframe: 4 weeks
• Results posted on: 2016-01-08

Participant Flow

Participant milestones

Measure	Beetroot Juice Beetroot juice, 4 weeks 250ml daily	Nitrate-free Beetroot Juice Nitrate-free beetroot juice, 4 weeks 250ml daily
Overall Study STARTED	34	34
Overall Study COMPLETED	32	32
Overall Study NOT COMPLETED	2	2

Reasons for withdrawal

Measure	Beetroot Juice Beetroot juice, 4 weeks 250ml daily	Nitrate-free Beetroot Juice Nitrate-free beetroot juice, 4 weeks 250ml daily
Overall Study Withdrawal by Subject	2	2

Baseline Characteristics

The Chronic Effects of Beetroot Juice in Hypertensive Subjects

Baseline characteristics by cohort

Measure	Beetroot Juice n=32 Participants Beetroot juice 4 weeks 250ml daily	Nitrate-free Beetroot Juice n=32 Participants Nitrate-free beetroot juice, 4 weeks 250ml daily	Total n=64 Participants Total of all reporting groups
Age, Continuous	57.6 years STANDARD_DEVIATION 13.9 • n=5 Participants	56.3 years STANDARD_DEVIATION 16.4 • n=7 Participants	56.9 years STANDARD_DEVIATION 15.1 • n=5 Participants
Sex: Female, Male Female	16 Participants n=5 Participants	22 Participants n=7 Participants	38 Participants n=5 Participants
Sex: Female, Male Male	16 Participants n=5 Participants	10 Participants n=7 Participants	26 Participants n=5 Participants

PRIMARY outcome

Timeframe: 4 weeks

Outcome measures

Measure	Beetroot Juice n=32 Participants Beetroot juice, 4 weeks 250ml daily	Nitrate-free Beetroot Juice n=32 Participants Nitrate-free beetroot juice, 4 weeks 250ml daily
Difference in Change in Clinic Systolic Blood Pressure From Baseline	-8.7 mmHg Standard Deviation 8.2	-1.0 mmHg Standard Deviation 8.4

PRIMARY outcome

Timeframe: 4 weeks

Outcome measures

Measure	Beetroot Juice n=32 Participants Beetroot juice, 4 weeks 250ml daily	Nitrate-free Beetroot Juice n=32 Participants Nitrate-free beetroot juice, 4 weeks 250ml daily
Difference in Change in Clinic Diastolic Blood Pressure From Baseline	-3.2 mmHg Standard Deviation 5.4	-0.7 mmHg Standard Deviation 4.2

PRIMARY outcome

Timeframe: 4 weeks

Outcome measures

Measure	Beetroot Juice n=32 Participants Beetroot juice, 4 weeks 250ml daily	Nitrate-free Beetroot Juice n=32 Participants Nitrate-free beetroot juice, 4 weeks 250ml daily
Difference in Change in Ambulatory Systolic Blood Pressure From Baseline	-6.6 mmHg Standard Deviation 6.5	0.8 mmHg Standard Deviation 4.9

PRIMARY outcome

Timeframe: 4 weeks

Outcome measures

Measure	Beetroot Juice n=32 Participants Beetroot juice, 4 weeks 250ml daily	Nitrate-free Beetroot Juice n=32 Participants Nitrate-free beetroot juice, 4 weeks 250ml daily
Difference in Change in Ambulatory Diastolic Blood Pressure From Baseline	-4.3 mmHg Standard Deviation 6.0	0.9 mmHg Standard Deviation 3.8

SECONDARY outcome

Timeframe: 4 weeks

Outcome measures

Measure	Beetroot Juice n=32 Participants Beetroot juice, 4 weeks 250ml daily	Nitrate-free Beetroot Juice n=32 Participants Nitrate-free beetroot juice, 4 weeks 250ml daily
Difference in Change in Plasma Nitrite Concentration From Baseline	0.53 umol/L Standard Deviation 0.37	0.01 umol/L Standard Deviation 0.16

SECONDARY outcome

Timeframe: 4 weeks

as measured by flow-mediated dilatation [%change in diameter of vessel] - an increase in diameter demonstrates an improvement in endothelial function

Outcome measures

Measure	Beetroot Juice n=32 Participants Beetroot juice, 4 weeks 250ml daily	Nitrate-free Beetroot Juice n=32 Participants Nitrate-free beetroot juice, 4 weeks 250ml daily
Difference in Change in Endothelial Function From Baseline	0.9 % dilatation Standard Deviation 1.3	0.1 % dilatation Standard Deviation 0.6

SECONDARY outcome

Timeframe: 4 weeks

carotid-femoral pulse wave velocity [m/s] measured by Vicorder

Outcome measures

Measure	Beetroot Juice n=32 Participants Beetroot juice, 4 weeks 250ml daily	Nitrate-free Beetroot Juice n=32 Participants Nitrate-free beetroot juice, 4 weeks 250ml daily
Difference in Change in Arterial Stiffness From Baseline	-0.59 m/s Standard Deviation 0.93	0.01 m/s Standard Deviation 1.11

Adverse Events

Beetroot Juice

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Nitrate-free Beetroot Juice

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Professor Amrita Ahluwalia

Queen Mary University London

Phone: 02078825720

Email: a.ahluwalia@qmul.ac.uk

Results disclosure agreements

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