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Trial Outcomes & Findings for Acute Effects of Beet Juice Consumption on Exercise Capacity in Heart Failure (NCT NCT01946542)

NCT ID: NCT01946542

Last Updated: 2015-12-14

Results Overview

treadmill time to exhaustion, cardiopulmonary exercise test

Recruitment status

TERMINATED

Study phase

PHASE1/PHASE2

Target enrollment

2 participants

Primary outcome timeframe

Testing Visit 1 (1-2 weeks from baseline) and Testing Visit 2 (2-3 weeks from baseline)

Results posted on

2015-12-14

Participant Flow

6 participants signed consent. 4 participants were screen failures. 2 participants were randomized.

Participant milestones

Participant milestones
Measure
Placebo First Then Beet Juice Concentrate
Testing visit 1: Participants are given a placebo drink, single dose. The placebo drink is taste and color-matched to the experimental drink. Testing visit 2: Participants are given a single dose of beet juice concentrate, roughly 70 mL.
Beet Juice Concentrate First, Then Placebo
Testing visit 1: Participants are given a single dose of beet juice concentrate, roughly 70 mL. Testing Visit 2: Participants are given a placebo drink, single dose. The placebo drink is taste and color-matched to the experimental drink.
Testing Visit 1
STARTED
1
1
Testing Visit 1
COMPLETED
1
1
Testing Visit 1
NOT COMPLETED
0
0
Testing Visit 2
STARTED
1
1
Testing Visit 2
COMPLETED
1
1
Testing Visit 2
NOT COMPLETED
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Acute Effects of Beet Juice Consumption on Exercise Capacity in Heart Failure

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Placebo First Then Beet Juice Concentrate
n=1 Participants
Testing visit 1: Participants are given a placebo drink, single dose. The placebo drink is taste and color-matched to the experimental drink. Testing visit 2: Participants are given a single dose of beet juice concentrate, roughly 70 mL.
Beet Juice Concentrate First, Then Placebo
n=1 Participants
Testing visit 1: Participants are given a single dose of beet juice concentrate, roughly 70 mL. Testing Visit 2: Participants are given a placebo drink, single dose. The placebo drink is taste and color-matched to the experimental drink.
Total
n=2 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
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Age, Categorical
>=65 years
1 Participants
n=5 Participants
1 Participants
n=7 Participants
2 Participants
n=5 Participants
Sex: Female, Male
Female
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Sex: Female, Male
Male
1 Participants
n=5 Participants
1 Participants
n=7 Participants
2 Participants
n=5 Participants
Race/Ethnicity, Customized
White
1 participants
n=5 Participants
0 participants
n=7 Participants
1 participants
n=5 Participants
Race/Ethnicity, Customized
Black
0 participants
n=5 Participants
1 participants
n=7 Participants
1 participants
n=5 Participants

PRIMARY outcome

Timeframe: Testing Visit 1 (1-2 weeks from baseline) and Testing Visit 2 (2-3 weeks from baseline)

Population: Given that only one participant completed each arm of the study, we are unable to report outcomes as group means. To report the individual demographic, clinical, and/or physiological characteristics of these participants would present significant and unnecessary risk of loss of confidentially. Thus, no outcome data is reported.

treadmill time to exhaustion, cardiopulmonary exercise test

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Testing Visit 1 (1-2 weeks from baseline) and Testing Visit 2 (2-3 weeks from baseline)

Population: Given that only one participant completed each arm of the study, we are unable to report outcomes as group means. To report the individual demographic, clinical, and/or physiological characteristics of these participants would present significant and unnecessary risk of loss of confidentially. Thus, no outcome data is reported.

flow-mediated dilation (FMD)

Outcome measures

Outcome data not reported

Adverse Events

Placebo

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

Beet Juice Concentrate

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

William Kraus

Duke University Medical Center

Phone: 919-684-2063

Results disclosure agreements

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