Trial Outcomes & Findings for Beet the Cold: The Effect of Inorganic Nitrate Supplementation in Individuals With Raynaud's Phenomenon (NCT NCT03129178)
NCT ID: NCT03129178
Last Updated: 2020-02-10
Results Overview
Peripheral blood flow (CVC = skin flux/MAP; flux.mmHg-1).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
27 participants
Primary outcome timeframe
Baseline (day 1), Acute (2 or 23), Chronic (day 16 or 36).
Results posted on
2020-02-10
Participant Flow
96 people were assessed for eligibility from clinic letters, word of mouth, local groups and via the clinical trials website. Recruitment occurred from 06-07-2017 - 29-05-2018.
27 participants were consented.
Participant milestones
| Measure |
Beetroot Juice, Then Nitrate Depleted Beetroot Juice
Participants consumed 140ml of beetroot juice prior to their first experimental visit. Participants will then be asked to consume 70ml a day for 2 weeks and final visit the investigators once more following another 140ml drink.
Following a 7 day washout, then swapped into the nitrate depleted beetroot juice arm.
|
Nitrate Depleted Beetroot Juice, Then Beetroot Juice
Participants consumed 140ml of nitrate depleted beetroot juice prior to their first experimental visit. Participants will then be asked to consume 70ml a day for 2 weeks and final visit the investigators once more following another 140ml drink.
Following a 7 day washout, then swapped into the beetroot juice arm.
|
|---|---|---|
|
Overall Study
STARTED
|
13
|
13
|
|
Overall Study
COMPLETED
|
12
|
11
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Beet the Cold: The Effect of Inorganic Nitrate Supplementation in Individuals With Raynaud's Phenomenon
Baseline characteristics by cohort
| Measure |
Beetroot Juice, Then, Nitrate Depleted Beetroot Juice
n=11 Participants
Participants consumed 140ml of beetroot juice prior to their first experimental visit. Participants will then be asked to consume 70ml a day for 2 weeks and final visit the investigators once more following another 140ml drink.
Following a 7 day washout, then swapped into the nitrate depleted beetroot juice arm.
|
Nitrate Depleted Beetroot Juice, Then, Beetroot Juice
n=12 Participants
Participants consumed 140ml of nitrate depleted beetroot juice prior to their first experimental visit. Participants will then be asked to consume 70ml a day for 2 weeks and final visit the investigators once more following another 140ml drink.
Following a 7 day washout, then swapped into the beetroot juice arm.
|
Total
n=23 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
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
7 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Age, Continuous
|
65.7 years
STANDARD_DEVIATION 16.0 • n=5 Participants
|
63.0 years
STANDARD_DEVIATION 15.2 • n=7 Participants
|
64.3 years
STANDARD_DEVIATION 15.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
11 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline (day 1), Acute (2 or 23), Chronic (day 16 or 36).Population: 20 individuals with raynauds phenomenon. Result reported is Blood flow (CVC), 10 minutes after rewarming for the chronic exposures (Baseline (day 1), visit 2 (day 2), 3 (day 16), 4 (day 23) and 5 (day 36) respectfully).
Peripheral blood flow (CVC = skin flux/MAP; flux.mmHg-1).
Outcome measures
| Measure |
Concentrated Beetroot Juice
n=20 Participants
Participants will be asked to consume 140ml of beetroot juice prior to their first experimental visit. Participants will then be asked to consume 70ml a day for 2 weeks and final visit the investigators once more following another 140ml drink.
Concentrated beetroot juice: Acute and chronic supplementation of beetroot juice.
|
Nitrate Depleted Beetroot Juice
n=20 Participants
Participants will be asked to consume 140ml of placebo prior to their first experimental visit. Participants will then be asked to consume 70ml a day for 2 weeks and final visit the investigators once more following another 140ml drink.
Concentrated beetroot juice: Acute and chronic supplementation of beetroot juice.
|
|---|---|---|
|
Peripheral Blood Flow
Baseline (day 1)
|
3.7 flux.mmHg-1
Standard Deviation 0.4
|
3.7 flux.mmHg-1
Standard Deviation 0.4
|
|
Peripheral Blood Flow
Acute (2 or 23)
|
4.1 flux.mmHg-1
Standard Deviation 0.3
|
3.7 flux.mmHg-1
Standard Deviation 0.3
|
|
Peripheral Blood Flow
Chronic (day 16 or 36)
|
4.7 flux.mmHg-1
Standard Deviation 0.4
|
5.2 flux.mmHg-1
Standard Deviation 0.4
|
PRIMARY outcome
Timeframe: Baseline (day 1), Acute (2 or 23), Chronic (day 16 or 36).Skin temperature (via thermal imaging).
Outcome measures
| Measure |
Concentrated Beetroot Juice
n=23 Participants
Participants will be asked to consume 140ml of beetroot juice prior to their first experimental visit. Participants will then be asked to consume 70ml a day for 2 weeks and final visit the investigators once more following another 140ml drink.
Concentrated beetroot juice: Acute and chronic supplementation of beetroot juice.
|
Nitrate Depleted Beetroot Juice
n=23 Participants
Participants will be asked to consume 140ml of placebo prior to their first experimental visit. Participants will then be asked to consume 70ml a day for 2 weeks and final visit the investigators once more following another 140ml drink.
Concentrated beetroot juice: Acute and chronic supplementation of beetroot juice.
|
|---|---|---|
|
Skin Temperature.
Baseline (day 1)
|
32.4 Degree Celsius
Standard Deviation 3.0
|
32.4 Degree Celsius
Standard Deviation 3.0
|
|
Skin Temperature.
Acute (day 2 or 23)
|
32.1 Degree Celsius
Standard Deviation 2.9
|
32.0 Degree Celsius
Standard Deviation 3.0
|
|
Skin Temperature.
Chronic (day 16 or 36)
|
32.2 Degree Celsius
Standard Deviation 3.4
|
32.4 Degree Celsius
Standard Deviation 2.9
|
SECONDARY outcome
Timeframe: Baseline (day 1), Acute (2 or 23), Chronic (day 16 or 36).Perceived discomfort. Thermal discomfort were measured using a 20 cm scale (0 = very cold/uncomfortable; 10 = neutral; 20 = very hot/comfortable; modified from Zhang et al. (2004)) and recorded prior to immersion, during immersion and every 2 minutes of the rewarming period.
Outcome measures
| Measure |
Concentrated Beetroot Juice
n=23 Participants
Participants will be asked to consume 140ml of beetroot juice prior to their first experimental visit. Participants will then be asked to consume 70ml a day for 2 weeks and final visit the investigators once more following another 140ml drink.
Concentrated beetroot juice: Acute and chronic supplementation of beetroot juice.
|
Nitrate Depleted Beetroot Juice
n=23 Participants
Participants will be asked to consume 140ml of placebo prior to their first experimental visit. Participants will then be asked to consume 70ml a day for 2 weeks and final visit the investigators once more following another 140ml drink.
Concentrated beetroot juice: Acute and chronic supplementation of beetroot juice.
|
|---|---|---|
|
Perceived Discomfort
Baseline (day 1)
|
13.4 score on a scale
Standard Deviation 3.8
|
13.4 score on a scale
Standard Deviation 3.8
|
|
Perceived Discomfort
Acute (day 2 or 23)
|
13.1 score on a scale
Standard Deviation 3.2
|
12.6 score on a scale
Standard Deviation 3.7
|
|
Perceived Discomfort
Chronic (day 16 or 36)
|
13.5 score on a scale
Standard Deviation 3.5
|
12.9 score on a scale
Standard Deviation 3.0
|
SECONDARY outcome
Timeframe: During qualitative interviews after the intervention has ended (post day 36).Interview. Specifically, semi-structured interviews explored participants' experiences of the study procedures and consumption of beetroot juice. Interviews were conducted by a researcher with experience in qualitative research methods. Interviews were recorded, transcribed verbatim, and analysed through thematic analysis as outlined by Braun and Clarke (2006). Participants were asked about the testing procedures and their thoughts on the juice.
Outcome measures
| Measure |
Concentrated Beetroot Juice
n=10 Participants
Participants will be asked to consume 140ml of beetroot juice prior to their first experimental visit. Participants will then be asked to consume 70ml a day for 2 weeks and final visit the investigators once more following another 140ml drink.
Concentrated beetroot juice: Acute and chronic supplementation of beetroot juice.
|
Nitrate Depleted Beetroot Juice
n=10 Participants
Participants will be asked to consume 140ml of placebo prior to their first experimental visit. Participants will then be asked to consume 70ml a day for 2 weeks and final visit the investigators once more following another 140ml drink.
Concentrated beetroot juice: Acute and chronic supplementation of beetroot juice.
|
|---|---|---|
|
Acceptability to Participants
|
10 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: From start of study recruitment until the last participant is randomised. Estimated assesment period 6 - 52 weeksNumber of participants who remained in the study
Outcome measures
| Measure |
Concentrated Beetroot Juice
n=27 Participants
Participants will be asked to consume 140ml of beetroot juice prior to their first experimental visit. Participants will then be asked to consume 70ml a day for 2 weeks and final visit the investigators once more following another 140ml drink.
Concentrated beetroot juice: Acute and chronic supplementation of beetroot juice.
|
Nitrate Depleted Beetroot Juice
Participants will be asked to consume 140ml of placebo prior to their first experimental visit. Participants will then be asked to consume 70ml a day for 2 weeks and final visit the investigators once more following another 140ml drink.
Concentrated beetroot juice: Acute and chronic supplementation of beetroot juice.
|
|---|---|---|
|
Overall Number of Participants Recruited
|
23 Participants
|
—
|
SECONDARY outcome
Timeframe: Baseline (day 1), Acute (2 or 23), Chronic (day 16 or 36).Perceived pain. Pain sensation was assessed using a numerical rating scale for pain (0 no pain, 10 unimaginable, unspeakable pain; (Ferreira-Valente et al., 2011)) at the same time points.
Outcome measures
| Measure |
Concentrated Beetroot Juice
n=23 Participants
Participants will be asked to consume 140ml of beetroot juice prior to their first experimental visit. Participants will then be asked to consume 70ml a day for 2 weeks and final visit the investigators once more following another 140ml drink.
Concentrated beetroot juice: Acute and chronic supplementation of beetroot juice.
|
Nitrate Depleted Beetroot Juice
n=23 Participants
Participants will be asked to consume 140ml of placebo prior to their first experimental visit. Participants will then be asked to consume 70ml a day for 2 weeks and final visit the investigators once more following another 140ml drink.
Concentrated beetroot juice: Acute and chronic supplementation of beetroot juice.
|
|---|---|---|
|
Perceived Pain
Baseline (day 1)
|
0.2 score on a scale
Standard Deviation 0.6
|
0.2 score on a scale
Standard Deviation 0.6
|
|
Perceived Pain
Acute (day 2 or 23)
|
0.3 score on a scale
Standard Deviation 0.8
|
0.2 score on a scale
Standard Deviation 0.6
|
|
Perceived Pain
Chronic (day 16 or 36)
|
0.2 score on a scale
Standard Deviation 0.6
|
0.9 score on a scale
Standard Deviation 2.7
|
SECONDARY outcome
Timeframe: During qualitative interviews after the intervention has ended (post day 36).Population: Qualitative outcome.
Feasible to participants via interview. Specifically, semi-structured interviews explored participants' experiences of the study procedures and consumption of beetroot juice. Interviews were conducted by a researcher with experience in qualitative research methods. Interviews were recorded, transcribed verbatim, and analysed through thematic analysis as outlined by Braun and Clarke (2006).
Outcome measures
| Measure |
Concentrated Beetroot Juice
n=10 Participants
Participants will be asked to consume 140ml of beetroot juice prior to their first experimental visit. Participants will then be asked to consume 70ml a day for 2 weeks and final visit the investigators once more following another 140ml drink.
Concentrated beetroot juice: Acute and chronic supplementation of beetroot juice.
|
Nitrate Depleted Beetroot Juice
n=10 Participants
Participants will be asked to consume 140ml of placebo prior to their first experimental visit. Participants will then be asked to consume 70ml a day for 2 weeks and final visit the investigators once more following another 140ml drink.
Concentrated beetroot juice: Acute and chronic supplementation of beetroot juice.
|
|---|---|---|
|
Feasible to Participants
|
10 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: From date of randomization until the end of the last study visit. Estimated assesment period 6 - 52 weeksEstablish retention rates (Descriptive statistics)
Outcome measures
| Measure |
Concentrated Beetroot Juice
n=27 Participants
Participants will be asked to consume 140ml of beetroot juice prior to their first experimental visit. Participants will then be asked to consume 70ml a day for 2 weeks and final visit the investigators once more following another 140ml drink.
Concentrated beetroot juice: Acute and chronic supplementation of beetroot juice.
|
Nitrate Depleted Beetroot Juice
Participants will be asked to consume 140ml of placebo prior to their first experimental visit. Participants will then be asked to consume 70ml a day for 2 weeks and final visit the investigators once more following another 140ml drink.
Concentrated beetroot juice: Acute and chronic supplementation of beetroot juice.
|
|---|---|---|
|
Establish Retention Rates
|
23 Participants
|
—
|
Adverse Events
Concentrated Beetroot Juice
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Nitrate Depleted Beetroot Juice
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Concentrated Beetroot Juice
n=26 participants at risk
Participants will be asked to consume 140ml of beetroot juice prior to their first experimental visit. Participants will then be asked to consume 70ml a day for 2 weeks and final visit the investigators once more following another 140ml drink.
Concentrated beetroot juice: Acute and chronic supplementation of beetroot juice.
Total time on this arm is 14 days.
|
Nitrate Depleted Beetroot Juice
n=26 participants at risk
Participants will be asked to consume 140ml of placebo prior to their first experimental visit. Participants will then be asked to consume 70ml a day for 2 weeks and final visit the investigators once more following another 140ml drink.
Concentrated beetroot juice: Acute and chronic supplementation of beetroot juice.
Total time on this arm is 14 days.
|
|---|---|---|
|
Gastrointestinal disorders
GI distress
|
3.8%
1/26 • Number of events 1 • Two weeks for each intervention.
|
3.8%
1/26 • Number of events 1 • Two weeks for each intervention.
|
|
General disorders
Nausea / sickness
|
3.8%
1/26 • Number of events 1 • Two weeks for each intervention.
|
3.8%
1/26 • Number of events 1 • Two weeks for each intervention.
|
|
Blood and lymphatic system disorders
Hot flush
|
3.8%
1/26 • Number of events 1 • Two weeks for each intervention.
|
0.00%
0/26 • Two weeks for each intervention.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place