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Trial Outcomes & Findings for Dietary Nitrate Supplementation and Thermoregulation (NCT NCT03506646)

NCT ID: NCT03506646

Last Updated: 2024-11-22

Results Overview

Endothelial function will be assessed using flow mediated dilation to measure vasodilation in the brachial artery (baFMD).

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

11 participants

Primary outcome timeframe

Pre and post treatment

Results posted on

2024-11-22

Participant Flow

Participant milestones

Participant milestones
Measure
Beetroot Juice First, Then Placebo
Subjects will be tested on two different days. The first day will be beetroot juice and the second day will be a placebo. Testing will take place approximately one hour after intake. There will be a 14 day washout period between testing days. Beetroot juice: Beetroot juice serves as a mode of dietary nitrate supplementation. This will be a double-blinded, randomized, cross-over design to examine the effects of beetroot juice on endothelial function, leg function, and thermoregulation.
Placebo First, Then Beetroot Juice
Subjects will be tested on two different days. The first day will be a placebo and the second day will be beetroot juice. Testing will take place approximately one hour after intake. There will be a 14 day washout period between testing days. Beetroot juice: Beetroot juice serves as a mode of dietary nitrate supplementation. This will be a double-blinded, randomized, cross-over design to examine the effects of beetroot juice on endothelial function, leg function, and thermoregulation.
First Intervention (Day 1)
STARTED
6
5
First Intervention (Day 1)
COMPLETED
6
5
First Intervention (Day 1)
NOT COMPLETED
0
0
Washout (14 Days)
STARTED
6
5
Washout (14 Days)
COMPLETED
6
5
Washout (14 Days)
NOT COMPLETED
0
0
Second Intervention (1 Day)
STARTED
6
5
Second Intervention (1 Day)
COMPLETED
6
5
Second Intervention (1 Day)
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

Baseline characteristics by cohort
Measure
Beetroot Juice First, Then Placebo
n=6 Participants
Subjects will be tested on two different days. The first day will be beetroot juice and the second day will be a placebo. Testing will take place approximately one hour after intake. There will be a 14 day washout period between testing days. Beetroot juice: Beetroot juice serves as a mode of dietary nitrate supplementation. This will be a double-blinded, randomized, cross-over design to examine the effects of beetroot juice on endothelial function, leg function, and thermoregulation.
Placebo First, Then Beetroot Juice
n=5 Participants
Subjects will be tested on two different days. The first day will be a placebo and the second day will be beetroot juice. Testing will take place approximately one hour after intake. There will be a 14 day washout period between testing days. Beetroot juice: Beetroot juice serves as a mode of dietary nitrate supplementation. This will be a double-blinded, randomized, cross-over design to examine the effects of beetroot juice on endothelial function, leg function, and thermoregulation.
Total
n=11 Participants
Total of all reporting groups
Age, Categorical
<=18 years
0 Participants
n=6 Participants
0 Participants
n=5 Participants
0 Participants
n=11 Participants
Age, Categorical
Between 18 and 65 years
2 Participants
n=6 Participants
1 Participants
n=5 Participants
3 Participants
n=11 Participants
Age, Categorical
>=65 years
4 Participants
n=6 Participants
4 Participants
n=5 Participants
8 Participants
n=11 Participants
Age, Continuous
69.5 years
STANDARD_DEVIATION 7.26 • n=6 Participants
70.80 years
STANDARD_DEVIATION 10.28 • n=5 Participants
70.1 years
STANDARD_DEVIATION 8.3 • n=11 Participants
Sex: Female, Male
Female
3 Participants
n=6 Participants
3 Participants
n=5 Participants
6 Participants
n=11 Participants
Sex: Female, Male
Male
3 Participants
n=6 Participants
2 Participants
n=5 Participants
5 Participants
n=11 Participants
Race and Ethnicity Not Collected
—
—
0 Participants
Race and Ethnicity were not collected from any participant.
Region of Enrollment
United States
6 participants
n=6 Participants
5 participants
n=5 Participants
11 participants
n=11 Participants
Height
165.92 cm
STANDARD_DEVIATION 16.10 • n=6 Participants
160 cm
STANDARD_DEVIATION 11.77 • n=5 Participants
162.96 cm
STANDARD_DEVIATION 13.94 • n=11 Participants
Weight
84.17 kg
STANDARD_DEVIATION 17.34 • n=6 Participants
68.54 kg
STANDARD_DEVIATION 12.57 • n=5 Participants
76.35 kg
STANDARD_DEVIATION 14.95 • n=11 Participants
Hand grip strength
29.33 kg
STANDARD_DEVIATION 14.75 • n=6 Participants
29.60 kg
STANDARD_DEVIATION 8.65 • n=5 Participants
29.47 kg
STANDARD_DEVIATION 11.70 • n=11 Participants
Body fat percentage
39 % body fat
STANDARD_DEVIATION 10.22 • n=6 Participants
35.7 % body fat
STANDARD_DEVIATION 8.08 • n=5 Participants
37.35 % body fat
STANDARD_DEVIATION 9.15 • n=11 Participants
Resting Heart Rate
71.2 beats per min
STANDARD_DEVIATION 8.9 • n=6 Participants
68.2 beats per min
STANDARD_DEVIATION 14.5 • n=5 Participants
69.8 beats per min
STANDARD_DEVIATION 11.2 • n=11 Participants
Resting Blood Pressure
Systolic blood pressure
134 mm/Hg
STANDARD_DEVIATION 11 • n=6 Participants
127 mm/Hg
STANDARD_DEVIATION 22 • n=5 Participants
131 mm/Hg
STANDARD_DEVIATION 16 • n=11 Participants
Resting Blood Pressure
Diastolic blood pressure
82 mm/Hg
STANDARD_DEVIATION 7 • n=6 Participants
79 mm/Hg
STANDARD_DEVIATION 5 • n=5 Participants
80 mm/Hg
STANDARD_DEVIATION 6 • n=11 Participants

PRIMARY outcome

Timeframe: Pre and post treatment

Population: 11 patients with peripheral artery disease were recruited and assigned to the beetroot juice and placebo groups in a randomized crossover study design.

Endothelial function will be assessed using flow mediated dilation to measure vasodilation in the brachial artery (baFMD).

Outcome measures

Outcome measures
Measure
Beetroot Juice
n=11 Participants
Participants will receive Beetroot juice supplementation.
Placebo
n=11 Participants
Participants will receive the Placebo
Brachial Artery Endothelial Function
Baseline
4.34 % dilation
Standard Deviation 1.39
4.31 % dilation
Standard Deviation 1.26
Brachial Artery Endothelial Function
Post Treatment
5.6 % dilation
Standard Deviation 1.65
4.35 % dilation
Standard Deviation 1.24

SECONDARY outcome

Timeframe: Pre and Post treatment

Population: 11 patients with peripheral artery disease were recruited and assigned to the beetroot juice and placebo groups in a randomized crossover study design.

Popliteal artery endothelial function will be measured using the flow mediated dilation (paFMD) technique to measure vasodilation with an ultrasound imaging system.

Outcome measures

Outcome measures
Measure
Beetroot Juice
n=11 Participants
Participants will receive Beetroot juice supplementation.
Placebo
n=11 Participants
Participants will receive the Placebo
Leg Endothelial Function
Baseline
2.45 % dilation
Standard Deviation 1.30
2.73 % dilation
Standard Deviation 1.46
Leg Endothelial Function
Post Treatment
4.11 % dilation
Standard Deviation 2.12
2.73 % dilation
Standard Deviation 1.46

SECONDARY outcome

Timeframe: 2 days

Muscle tissue oxygenation will be assessed by using near-infrared spectroscopy (NIRS) during a maximal walking protocol. Assessment is measured in arbitrary units as mean changes in deoxygenated hemoglobin (HHb)

Outcome measures

Outcome measures
Measure
Beetroot Juice
n=11 Participants
Participants will receive Beetroot juice supplementation.
Placebo
n=11 Participants
Participants will receive the Placebo
Muscle Tissue Oxygenation
Post Treatment
-9.48 arbitrary units
Standard Deviation 23.2
3.86 arbitrary units
Standard Deviation 26.7
Muscle Tissue Oxygenation
Baseline
7.19 arbitrary units
Standard Deviation 49.5
1.12 arbitrary units
Standard Deviation 30.1

SECONDARY outcome

Timeframe: maximum of 14 minutes each day for 2 days

Physical walking capacity will be measured during the Gardner treadmill protocol. Participants will walk on a treadmill at 2.0 mph. Grade will began at zero and will be increased by two percent every two minutes. Participants unable to walk at least 2.0 miles per hour (MPH) begin walking at 0.5 MPH and their speed is increased by 0.50 MPH every two minutes until the participant reaches 2.0 MPH. After reaching 2.0 MPH, treadmill grade is increased by two percent every two minutes. Participants are asked to continue walking without stopping until they cannot continue because of leg symptoms, exhaustion, or other symptoms.

Outcome measures

Outcome measures
Measure
Beetroot Juice
n=11 Participants
Participants will receive Beetroot juice supplementation.
Placebo
n=11 Participants
Participants will receive the Placebo
Physical Walking Capacity
Baseline
368.3 meters
Standard Deviation 243.3
366.1 meters
Standard Deviation 245.6
Physical Walking Capacity
Post treatment
460.5 meters
Standard Deviation 279.3
361.8 meters
Standard Deviation 262.9

SECONDARY outcome

Timeframe: maximum of 60 minutes each day for 2 days

Autonomic nervous system activity will be assessed using heart rate variability. Data represented as ratio between low frequency (LF) and high frequency (HF).

Outcome measures

Outcome measures
Measure
Beetroot Juice
n=11 Participants
Participants will receive Beetroot juice supplementation.
Placebo
n=11 Participants
Participants will receive the Placebo
Autonomic Nervous System Activity
Baseline
2.6 Ratio
Standard Deviation 0.8
2.4 Ratio
Standard Deviation 0.5
Autonomic Nervous System Activity
Post treatment
2.1 Ratio
Standard Deviation 0.7
2.8 Ratio
Standard Deviation 0.6

SECONDARY outcome

Timeframe: maximum of 30 minutes each day for 2 days

Microvascular function will be assessed using near-infrared spectroscopy. Changes in tissue oxygenation rate following reactive hyperemia will be denoted as % recovery rate used to interpret mitochondrial function.

Outcome measures

Outcome measures
Measure
Beetroot Juice
n=11 Participants
Participants will receive Beetroot juice supplementation.
Placebo
n=11 Participants
Participants will receive the Placebo
Microvascular Function
Baseline
24.74 % recovery rate
Standard Deviation 15.02
28.05 % recovery rate
Standard Deviation 17.95
Microvascular Function
Post treatment
46.87 % recovery rate
Standard Deviation 18.18
30.13 % recovery rate
Standard Deviation 17.57

SECONDARY outcome

Timeframe: 2 days

Participants will have blood drawn from an antecubital vein using a vacutainer and needle (25 gauge) prior to baseline testing and experimental trial testing. This will be done to measure nitrate/nitrite levels at baseline, post beetroot juice (BRJ) intake, and post placebo intake.

Outcome measures

Outcome measures
Measure
Beetroot Juice
n=11 Participants
Participants will receive Beetroot juice supplementation.
Placebo
n=11 Participants
Participants will receive the Placebo
Blood Nitrate/Nitrite Levels
Pre treatment
.22 micromolar concentration
Standard Deviation .09
.27 micromolar concentration
Standard Deviation .16
Blood Nitrate/Nitrite Levels
Post Treatment
1.54 micromolar concentration
Standard Deviation .44
.25 micromolar concentration
Standard Deviation .17

Adverse Events

Beetroot Juice

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

Placebo

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

Song-Young Park

University of Nebraska at Omaha

Phone: 402-554-3374

Results disclosure agreements

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