Trial Outcomes & Findings for Effect of Beetroot Juice on Blood Pressure Regulation in Post Menopausal Women (NCT NCT03380000)
NCT ID: NCT03380000
Last Updated: 2022-07-12
Results Overview
Aortic Blood pressures were measured in the arm (cuff) and estimated in the aorta (radial artery tonometry).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
16 participants
Primary outcome timeframe
Resting systolic blood pressure at 90 minutes after beetroot juice ingestion
Results posted on
2022-07-12
Participant Flow
20 healthy postmenopausal women were screened for eligibility between October 15, 2013 and January 1, 2020 at State College community in State College, PA.
16 of 20 participants were randomized. Of those not randomized, 3 did not meet inclusion criteria and 1 withdrew after the familiarization visit.
Participant milestones
| Measure |
Nitrate Depleted Beetroot Juice First, Then Nitrate Rich Beetroot Juice
Subjects consumed 140 ml of beetroot juice (Beet-It Organic Shot) approximately 90 min before physiological testing.
Nitrate-depleted Beetroot juice (placebo): This beverage is identical in look and taste to the Beet-It organic shot, but has the nitrate removed. It is also bottled and supplied by James White Drinks (UK).
Nitrate-rich Beetroot juice: This beverage contains 0.3 g of inorganic nitrate per 70 ml container, and is bottled and supplied by James White Drinks (UK).
|
Nitrate Rich Beetroot Juice First, Then Nitrate Depleted Beetroot Juice
Subjects consumed 140 ml of beetroot juice (Beet-It Organic Shot) approximately 90 min before physiological testing.
Nitrate-rich Beetroot juice: This beverage contains 0.3 g of inorganic nitrate per 70 ml container, and is bottled and supplied by James White Drinks (UK).
Nitrate-depleted Beetroot juice (placebo): This beverage is identical in look and taste to the Beet-It organic shot, but has the nitrate removed. It is also bottled and supplied by James White Drinks (UK).
|
|---|---|---|
|
First Intervention (1day)
STARTED
|
8
|
8
|
|
First Intervention (1day)
COMPLETED
|
8
|
8
|
|
First Intervention (1day)
NOT COMPLETED
|
0
|
0
|
|
Washout (>7days)
STARTED
|
8
|
8
|
|
Washout (>7days)
COMPLETED
|
8
|
8
|
|
Washout (>7days)
NOT COMPLETED
|
0
|
0
|
|
Second Intervention (1day)
STARTED
|
8
|
8
|
|
Second Intervention (1day)
COMPLETED
|
8
|
8
|
|
Second Intervention (1day)
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effect of Beetroot Juice on Blood Pressure Regulation in Post Menopausal Women
Baseline characteristics by cohort
| Measure |
Randomized, Nitrate-rich or -Depleted Beetroot Juice on Two Separate Days
n=13 Participants
Subjects consumed 140 ml of beetroot juice (Beet-It Organic Shot) approximately 90 min before physiological testing.
Nitrate-rich Beetroot juice: This beverage contains 0.3 g of inorganic nitrate per 70 ml container, and is bottled and supplied by James White Drinks (UK).
Nitrate-depleted Beetroot juice (placebo): This beverage is identical in look and taste to the Beet-It organic shot, but has the nitrate removed. It is also bottled and supplied by James White Drinks (UK).
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
9 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=5 Participants
|
|
Age, Continuous
|
63 year
STANDARD_DEVIATION 4.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
13 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
13 participants
n=5 Participants
|
|
Mean arterial pressure
|
91 mmHg
n=5 Participants
|
PRIMARY outcome
Timeframe: Resting systolic blood pressure at 90 minutes after beetroot juice ingestionPopulation: This was a crossover study where the same group of subjects was intervened with both nitrate-rich beetroot juice and nitrate depleted beetroot juice
Aortic Blood pressures were measured in the arm (cuff) and estimated in the aorta (radial artery tonometry).
Outcome measures
| Measure |
Randomized, Nitrate Rich Beetroot Juice
n=13 Participants
Subjects consumed 140 ml of beetroot juice (Beet-It Organic Shot) approximately 90 min before physiological testing.
Beetroot juice: This beverage contains 0.3 g of inorganic nitrate per 70 ml container, and is bottled and supplied by James White Drinks (UK).
|
Randomized, Nitrate Depleted Beetroot Juice
n=13 Participants
Subjects consumed 140 ml of beetroot juice (Beet-It Organic Placebo) approximately 90 min before physiological testing.
Beetroot juice placebo: This beverage is identical in look and taste to the Beet-It organic shot, but has the nitrate removed. It is also bottled and supplied by James White Drinks (UK).
|
|---|---|---|
|
Resting Aortic Blood Pressures
|
113.3 mmHg
Standard Error 4.1
|
116.9 mmHg
Standard Error 6.3
|
SECONDARY outcome
Timeframe: Change from baseline measures of plasma nitrate and nitrite at 90 minutes and at approximately 6 hoursPopulation: This study is a crossover study. Same subjects for nitrate-rich beetroot juice were intervened for nitrate-depleted beetroot juice.
Venous blood will be withdrawn (venipuncture) for determination of plasma nitrate and nitrite.
Outcome measures
| Measure |
Randomized, Nitrate Rich Beetroot Juice
n=13 Participants
Subjects consumed 140 ml of beetroot juice (Beet-It Organic Shot) approximately 90 min before physiological testing.
Beetroot juice: This beverage contains 0.3 g of inorganic nitrate per 70 ml container, and is bottled and supplied by James White Drinks (UK).
|
Randomized, Nitrate Depleted Beetroot Juice
n=13 Participants
Subjects consumed 140 ml of beetroot juice (Beet-It Organic Placebo) approximately 90 min before physiological testing.
Beetroot juice placebo: This beverage is identical in look and taste to the Beet-It organic shot, but has the nitrate removed. It is also bottled and supplied by James White Drinks (UK).
|
|---|---|---|
|
Blood Measures of Nitrate Absorption and Conversion
Plasma nitrate concentration
|
643.9 uM
Standard Error 45.7
|
39.2 uM
Standard Error 9.3
|
|
Blood Measures of Nitrate Absorption and Conversion
Plasma Nitrite concentration
|
0.402 uM
Standard Error 0.077
|
0.115 uM
Standard Error 0.027
|
SECONDARY outcome
Timeframe: Change from baseline resting pulse wave velocity at 90 minutes after beet root juice ingestionCarotid to femoral artery pulse wave velocity will be assessed using arterial tonometry.
Outcome measures
| Measure |
Randomized, Nitrate Rich Beetroot Juice
n=13 Participants
Subjects consumed 140 ml of beetroot juice (Beet-It Organic Shot) approximately 90 min before physiological testing.
Beetroot juice: This beverage contains 0.3 g of inorganic nitrate per 70 ml container, and is bottled and supplied by James White Drinks (UK).
|
Randomized, Nitrate Depleted Beetroot Juice
n=13 Participants
Subjects consumed 140 ml of beetroot juice (Beet-It Organic Placebo) approximately 90 min before physiological testing.
Beetroot juice placebo: This beverage is identical in look and taste to the Beet-It organic shot, but has the nitrate removed. It is also bottled and supplied by James White Drinks (UK).
|
|---|---|---|
|
Resting Arterial Stiffness/Wave Properties
|
7.328 m/s
Standard Error 0.407
|
7.572 m/s
Standard Error 0.384
|
SECONDARY outcome
Timeframe: Approximately 180 minutes after ingestion of beetroot juiceBeat-to-beat blood pressure (finger cuff) will be assessed at rest and during handgrip exercise to volitional fatigue.
Outcome measures
| Measure |
Randomized, Nitrate Rich Beetroot Juice
n=8 Participants
Subjects consumed 140 ml of beetroot juice (Beet-It Organic Shot) approximately 90 min before physiological testing.
Beetroot juice: This beverage contains 0.3 g of inorganic nitrate per 70 ml container, and is bottled and supplied by James White Drinks (UK).
|
Randomized, Nitrate Depleted Beetroot Juice
n=8 Participants
Subjects consumed 140 ml of beetroot juice (Beet-It Organic Placebo) approximately 90 min before physiological testing.
Beetroot juice placebo: This beverage is identical in look and taste to the Beet-It organic shot, but has the nitrate removed. It is also bottled and supplied by James White Drinks (UK).
|
|---|---|---|
|
Handgrip Exercise Blood Pressure Responses (Relative Change From Baseline)
|
25 percentage of change from baseline
Standard Error 3
|
30 percentage of change from baseline
Standard Error 5
|
SECONDARY outcome
Timeframe: Approximately 90 minutes after ingestion of beetroot juiceThe Borg Rating of Perceived Exertion Scale (RPE) was used to assess exercise intensity during handgrip exercise. The RPE scale ranges from a minimum of 6 (no exertion at all) to a maximum of 20 (maximal exertion) units on a scale.
Outcome measures
| Measure |
Randomized, Nitrate Rich Beetroot Juice
n=13 Participants
Subjects consumed 140 ml of beetroot juice (Beet-It Organic Shot) approximately 90 min before physiological testing.
Beetroot juice: This beverage contains 0.3 g of inorganic nitrate per 70 ml container, and is bottled and supplied by James White Drinks (UK).
|
Randomized, Nitrate Depleted Beetroot Juice
n=13 Participants
Subjects consumed 140 ml of beetroot juice (Beet-It Organic Placebo) approximately 90 min before physiological testing.
Beetroot juice placebo: This beverage is identical in look and taste to the Beet-It organic shot, but has the nitrate removed. It is also bottled and supplied by James White Drinks (UK).
|
|---|---|---|
|
Peak Rate of Perceived Exertion Scores During Handgrip Exercise
|
17.3 units on a scale
Standard Deviation 2.8
|
17.7 units on a scale
Standard Deviation 1.7
|
SECONDARY outcome
Timeframe: Approximately 90 minutes after ingestion of beetroot juiceTime to fatigue (seconds) was assessed during a progressive blood flow restricted handgrip exercise protocol.
Outcome measures
| Measure |
Randomized, Nitrate Rich Beetroot Juice
n=13 Participants
Subjects consumed 140 ml of beetroot juice (Beet-It Organic Shot) approximately 90 min before physiological testing.
Beetroot juice: This beverage contains 0.3 g of inorganic nitrate per 70 ml container, and is bottled and supplied by James White Drinks (UK).
|
Randomized, Nitrate Depleted Beetroot Juice
n=13 Participants
Subjects consumed 140 ml of beetroot juice (Beet-It Organic Placebo) approximately 90 min before physiological testing.
Beetroot juice placebo: This beverage is identical in look and taste to the Beet-It organic shot, but has the nitrate removed. It is also bottled and supplied by James White Drinks (UK).
|
|---|---|---|
|
Handgrip Exercise Tolerance
|
602.8 seconds
Standard Deviation 48.61
|
541.0 seconds
Standard Deviation 48.66
|
Adverse Events
Randomized, Nitrate Rich Beetroot Juice
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Randomized, Nitrate Depleted 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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place