Trial Outcomes & Findings for Dietary Nitrate and Physiological Aging (NCT NCT02593305)
NCT ID: NCT02593305
Last Updated: 2019-10-14
Results Overview
Carotid chemosensitivity examined by measuring hypoxia ventilatory responsiveness in older adults before and after 4 weeks of beet root juice supplementation and placebo. Chemoreflex sensitivity was quantified as the change in ventilation in relation to the change in pulse oxygen saturation.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
23 participants
Primary outcome timeframe
Pre and post 4 weeks dietary nitrate supplementation and pre and post 4 weeks of placebo.
Results posted on
2019-10-14
Participant Flow
Participant milestones
| Measure |
Nitrate First Arm
Subjects consumed beet root juice with nitrate for 4 weeks during the first arm of the study. After a 4 week washout period, subjects consumed beetroot juice without nitrate (placebo) for 4 weeks.
|
Placebo First Arm
Subjects consumed beet root juice without nitrate (placebo) for 4 weeks during the first arm of the study. After a 4 week washout period, subjects consumed beetroot juice with nitrate for 4 weeks.
|
Young Comparison Group
Young subjects only completed a single experimental visit and no intervention. Data from young were used for age-related comparisons at baseline.
|
|---|---|---|---|
|
Baseline 1
STARTED
|
7
|
6
|
10
|
|
Baseline 1
COMPLETED
|
7
|
6
|
10
|
|
Baseline 1
NOT COMPLETED
|
0
|
0
|
0
|
|
Post 1
STARTED
|
7
|
6
|
10
|
|
Post 1
COMPLETED
|
7
|
6
|
0
|
|
Post 1
NOT COMPLETED
|
0
|
0
|
10
|
|
Baseline 2
STARTED
|
7
|
6
|
0
|
|
Baseline 2
COMPLETED
|
7
|
6
|
0
|
|
Baseline 2
NOT COMPLETED
|
0
|
0
|
0
|
|
Post 2
STARTED
|
7
|
6
|
0
|
|
Post 2
COMPLETED
|
7
|
6
|
0
|
|
Post 2
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Nitrate First Arm
Subjects consumed beet root juice with nitrate for 4 weeks during the first arm of the study. After a 4 week washout period, subjects consumed beetroot juice without nitrate (placebo) for 4 weeks.
|
Placebo First Arm
Subjects consumed beet root juice without nitrate (placebo) for 4 weeks during the first arm of the study. After a 4 week washout period, subjects consumed beetroot juice with nitrate for 4 weeks.
|
Young Comparison Group
Young subjects only completed a single experimental visit and no intervention. Data from young were used for age-related comparisons at baseline.
|
|---|---|---|---|
|
Post 1
Comparison only group. No intervention.
|
0
|
0
|
10
|
Baseline Characteristics
Row population reflect each distinct age group. Row older adults =13 subjects. Row young adults = 10 subjects. Together the two age groups (rows) total the overall 23 subjects enrolled in the study.
Baseline characteristics by cohort
| Measure |
Nitrate First Arm
n=7 Participants
Subjects consumed beet root juice with nitrate for 4 weeks during the first arm of the study. After a 4 week washout period, subjects consumed beetroot juice without nitrate (placebo) for 4 weeks.
|
Placebo First Arm
n=6 Participants
Subjects consumed beet root juice without nitrate (placebo) for 4 weeks during the first arm of the study. After a 4 week washout period, subjects consumed beetroot juice with nitrate for 4 weeks.
|
Young Comparison Group
n=10 Participants
Young control group, used for age-related comparisons. This group did not go through any intervention.
|
Total
n=23 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=7 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=23 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=7 Participants
|
0 Participants
n=6 Participants
|
10 Participants
n=10 Participants
|
11 Participants
n=23 Participants
|
|
Age, Categorical
>=65 years
|
6 Participants
n=7 Participants
|
6 Participants
n=6 Participants
|
0 Participants
n=10 Participants
|
12 Participants
n=23 Participants
|
|
Age, Continuous
Older Adults
|
68 years
STANDARD_DEVIATION 3 • n=7 Participants • Row population reflect each distinct age group. Row older adults =13 subjects. Row young adults = 10 subjects. Together the two age groups (rows) total the overall 23 subjects enrolled in the study.
|
66 years
STANDARD_DEVIATION 2 • n=6 Participants • Row population reflect each distinct age group. Row older adults =13 subjects. Row young adults = 10 subjects. Together the two age groups (rows) total the overall 23 subjects enrolled in the study.
|
—
|
67 years
STANDARD_DEVIATION 3 • n=13 Participants • Row population reflect each distinct age group. Row older adults =13 subjects. Row young adults = 10 subjects. Together the two age groups (rows) total the overall 23 subjects enrolled in the study.
|
|
Age, Continuous
Young Adults
|
—
|
—
|
25 years
STANDARD_DEVIATION 4 • n=10 Participants • Row population reflect each distinct age group. Row older adults =13 subjects. Row young adults = 10 subjects. Together the two age groups (rows) total the overall 23 subjects enrolled in the study.
|
25 years
STANDARD_DEVIATION 4 • n=10 Participants • Row population reflect each distinct age group. Row older adults =13 subjects. Row young adults = 10 subjects. Together the two age groups (rows) total the overall 23 subjects enrolled in the study.
|
|
Sex: Female, Male
Female
|
2 Participants
n=7 Participants
|
4 Participants
n=6 Participants
|
5 Participants
n=10 Participants
|
11 Participants
n=23 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=7 Participants
|
2 Participants
n=6 Participants
|
5 Participants
n=10 Participants
|
12 Participants
n=23 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=7 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=23 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
7 Participants
n=7 Participants
|
6 Participants
n=6 Participants
|
10 Participants
n=10 Participants
|
23 Participants
n=23 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=7 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=23 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=7 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=23 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=7 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=10 Participants
|
1 Participants
n=23 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=7 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=23 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=7 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=23 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=7 Participants
|
6 Participants
n=6 Participants
|
9 Participants
n=10 Participants
|
22 Participants
n=23 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=7 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=23 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=7 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=23 Participants
|
|
Region of Enrollment
United States
|
7 participants
n=7 Participants
|
6 participants
n=6 Participants
|
10 participants
n=10 Participants
|
23 participants
n=23 Participants
|
|
Body Mass Index
Older Adults
|
26 kg/m^2
STANDARD_DEVIATION 4 • n=7 Participants • Row population reflect each distinct age group. Row older adults =13 subjects. Row young adults = 10 subjects. Together the two age groups (rows) total the overall 23 subjects enrolled in the study.
|
25 kg/m^2
STANDARD_DEVIATION 3 • n=6 Participants • Row population reflect each distinct age group. Row older adults =13 subjects. Row young adults = 10 subjects. Together the two age groups (rows) total the overall 23 subjects enrolled in the study.
|
—
|
26 kg/m^2
STANDARD_DEVIATION 3 • n=13 Participants • Row population reflect each distinct age group. Row older adults =13 subjects. Row young adults = 10 subjects. Together the two age groups (rows) total the overall 23 subjects enrolled in the study.
|
|
Body Mass Index
Young Adults
|
—
|
—
|
24 kg/m^2
STANDARD_DEVIATION 3 • n=10 Participants • Row population reflect each distinct age group. Row older adults =13 subjects. Row young adults = 10 subjects. Together the two age groups (rows) total the overall 23 subjects enrolled in the study.
|
24 kg/m^2
STANDARD_DEVIATION 3 • n=10 Participants • Row population reflect each distinct age group. Row older adults =13 subjects. Row young adults = 10 subjects. Together the two age groups (rows) total the overall 23 subjects enrolled in the study.
|
|
Systolic Blood Pressure
Older Adults
|
126 mmHg
STANDARD_DEVIATION 12 • n=7 Participants • Row population reflect each distinct age group. Row older adults =13 subjects. Row young adults = 10 subjects. Together the two age groups (rows) total the overall 23 subjects enrolled in the study.
|
118 mmHg
STANDARD_DEVIATION 5 • n=6 Participants • Row population reflect each distinct age group. Row older adults =13 subjects. Row young adults = 10 subjects. Together the two age groups (rows) total the overall 23 subjects enrolled in the study.
|
—
|
122 mmHg
STANDARD_DEVIATION 10 • n=13 Participants • Row population reflect each distinct age group. Row older adults =13 subjects. Row young adults = 10 subjects. Together the two age groups (rows) total the overall 23 subjects enrolled in the study.
|
|
Systolic Blood Pressure
Young Adults
|
—
|
—
|
119 mmHg
STANDARD_DEVIATION 8 • n=10 Participants • Row population reflect each distinct age group. Row older adults =13 subjects. Row young adults = 10 subjects. Together the two age groups (rows) total the overall 23 subjects enrolled in the study.
|
119 mmHg
STANDARD_DEVIATION 8 • n=10 Participants • Row population reflect each distinct age group. Row older adults =13 subjects. Row young adults = 10 subjects. Together the two age groups (rows) total the overall 23 subjects enrolled in the study.
|
|
Diastolic Blood Pressure
Older Adults
|
76 mmHg
STANDARD_DEVIATION 5 • n=7 Participants • Row population reflect each distinct age group. Row older adults =13 subjects. Row young adults = 10 subjects. Together the two age groups (rows) total the overall 23 subjects enrolled in the study.
|
75 mmHg
STANDARD_DEVIATION 6 • n=6 Participants • Row population reflect each distinct age group. Row older adults =13 subjects. Row young adults = 10 subjects. Together the two age groups (rows) total the overall 23 subjects enrolled in the study.
|
—
|
76 mmHg
STANDARD_DEVIATION 5 • n=13 Participants • Row population reflect each distinct age group. Row older adults =13 subjects. Row young adults = 10 subjects. Together the two age groups (rows) total the overall 23 subjects enrolled in the study.
|
|
Diastolic Blood Pressure
Young Adults
|
—
|
—
|
72 mmHg
STANDARD_DEVIATION 5 • n=10 Participants • Row population reflect each distinct age group. Row older adults =13 subjects. Row young adults = 10 subjects. Together the two age groups (rows) total the overall 23 subjects enrolled in the study.
|
72 mmHg
STANDARD_DEVIATION 5 • n=10 Participants • Row population reflect each distinct age group. Row older adults =13 subjects. Row young adults = 10 subjects. Together the two age groups (rows) total the overall 23 subjects enrolled in the study.
|
|
Glucose
Older Adults
|
97 mg/dl
STANDARD_DEVIATION 7 • n=7 Participants • Row population reflect each distinct age group. Row older adults =13 subjects. Row young adults = 10 subjects. Together the two age groups (rows) total the overall 23 subjects enrolled in the study.
|
96 mg/dl
STANDARD_DEVIATION 4 • n=6 Participants • Row population reflect each distinct age group. Row older adults =13 subjects. Row young adults = 10 subjects. Together the two age groups (rows) total the overall 23 subjects enrolled in the study.
|
—
|
96 mg/dl
STANDARD_DEVIATION 5 • n=13 Participants • Row population reflect each distinct age group. Row older adults =13 subjects. Row young adults = 10 subjects. Together the two age groups (rows) total the overall 23 subjects enrolled in the study.
|
|
Glucose
Young Adults
|
—
|
—
|
89 mg/dl
STANDARD_DEVIATION 5 • n=10 Participants • Row population reflect each distinct age group. Row older adults =13 subjects. Row young adults = 10 subjects. Together the two age groups (rows) total the overall 23 subjects enrolled in the study.
|
89 mg/dl
STANDARD_DEVIATION 5 • n=10 Participants • Row population reflect each distinct age group. Row older adults =13 subjects. Row young adults = 10 subjects. Together the two age groups (rows) total the overall 23 subjects enrolled in the study.
|
|
Total Cholesterol
Older Adults
|
171 mg/dl
STANDARD_DEVIATION 40 • n=7 Participants • Row population reflect each distinct age group. Row older adults =13 subjects. Row young adults = 10 subjects. Together the two age groups (rows) total the overall 23 subjects enrolled in the study.
|
184 mg/dl
STANDARD_DEVIATION 31 • n=6 Participants • Row population reflect each distinct age group. Row older adults =13 subjects. Row young adults = 10 subjects. Together the two age groups (rows) total the overall 23 subjects enrolled in the study.
|
—
|
177 mg/dl
STANDARD_DEVIATION 35 • n=13 Participants • Row population reflect each distinct age group. Row older adults =13 subjects. Row young adults = 10 subjects. Together the two age groups (rows) total the overall 23 subjects enrolled in the study.
|
|
Total Cholesterol
Young Adults
|
—
|
—
|
153 mg/dl
STANDARD_DEVIATION 22 • n=10 Participants • Row population reflect each distinct age group. Row older adults =13 subjects. Row young adults = 10 subjects. Together the two age groups (rows) total the overall 23 subjects enrolled in the study.
|
153 mg/dl
STANDARD_DEVIATION 22 • n=10 Participants • Row population reflect each distinct age group. Row older adults =13 subjects. Row young adults = 10 subjects. Together the two age groups (rows) total the overall 23 subjects enrolled in the study.
|
|
HDL
Older Adults
|
57 mg/dl
STANDARD_DEVIATION 19 • n=7 Participants • Row population reflect each distinct age group. Row older adults =13 subjects. Row young adults = 10 subjects. Together the two age groups (rows) total the overall 23 subjects enrolled in the study.
|
49 mg/dl
STANDARD_DEVIATION 21 • n=6 Participants • Row population reflect each distinct age group. Row older adults =13 subjects. Row young adults = 10 subjects. Together the two age groups (rows) total the overall 23 subjects enrolled in the study.
|
—
|
53 mg/dl
STANDARD_DEVIATION 19 • n=13 Participants • Row population reflect each distinct age group. Row older adults =13 subjects. Row young adults = 10 subjects. Together the two age groups (rows) total the overall 23 subjects enrolled in the study.
|
|
HDL
Young Adults
|
—
|
—
|
60 mg/dl
STANDARD_DEVIATION 15 • n=10 Participants • Row population reflect each distinct age group. Row older adults =13 subjects. Row young adults = 10 subjects. Together the two age groups (rows) total the overall 23 subjects enrolled in the study.
|
60 mg/dl
STANDARD_DEVIATION 15 • n=10 Participants • Row population reflect each distinct age group. Row older adults =13 subjects. Row young adults = 10 subjects. Together the two age groups (rows) total the overall 23 subjects enrolled in the study.
|
|
LDL
Older Adults
|
98 mg/dl
STANDARD_DEVIATION 33 • n=7 Participants • Row population reflect each distinct age group. Row older adults =13 subjects. Row young adults = 10 subjects. Together the two age groups (rows) total the overall 23 subjects enrolled in the study.
|
107 mg/dl
STANDARD_DEVIATION 33 • n=6 Participants • Row population reflect each distinct age group. Row older adults =13 subjects. Row young adults = 10 subjects. Together the two age groups (rows) total the overall 23 subjects enrolled in the study.
|
—
|
102 mg/dl
STANDARD_DEVIATION 32 • n=13 Participants • Row population reflect each distinct age group. Row older adults =13 subjects. Row young adults = 10 subjects. Together the two age groups (rows) total the overall 23 subjects enrolled in the study.
|
|
LDL
Young Adults
|
—
|
—
|
82 mg/dl
STANDARD_DEVIATION 23 • n=10 Participants • Row population reflect each distinct age group. Row older adults =13 subjects. Row young adults = 10 subjects. Together the two age groups (rows) total the overall 23 subjects enrolled in the study.
|
82 mg/dl
STANDARD_DEVIATION 23 • n=10 Participants • Row population reflect each distinct age group. Row older adults =13 subjects. Row young adults = 10 subjects. Together the two age groups (rows) total the overall 23 subjects enrolled in the study.
|
|
Triglycerides
Older Adults
|
84 mg/dl
STANDARD_DEVIATION 39 • n=7 Participants • Row population reflect each distinct age group. Row older adults =13 subjects. Row young adults = 10 subjects. Together the two age groups (rows) total the overall 23 subjects enrolled in the study.
|
144 mg/dl
STANDARD_DEVIATION 84 • n=6 Participants • Row population reflect each distinct age group. Row older adults =13 subjects. Row young adults = 10 subjects. Together the two age groups (rows) total the overall 23 subjects enrolled in the study.
|
—
|
111 mg/dl
STANDARD_DEVIATION 69 • n=13 Participants • Row population reflect each distinct age group. Row older adults =13 subjects. Row young adults = 10 subjects. Together the two age groups (rows) total the overall 23 subjects enrolled in the study.
|
|
Triglycerides
Young Adults
|
—
|
—
|
53 mg/dl
STANDARD_DEVIATION 12 • n=10 Participants • Row population reflect each distinct age group. Row older adults =13 subjects. Row young adults = 10 subjects. Together the two age groups (rows) total the overall 23 subjects enrolled in the study.
|
53 mg/dl
STANDARD_DEVIATION 12 • n=10 Participants • Row population reflect each distinct age group. Row older adults =13 subjects. Row young adults = 10 subjects. Together the two age groups (rows) total the overall 23 subjects enrolled in the study.
|
PRIMARY outcome
Timeframe: Pre and post 4 weeks dietary nitrate supplementation and pre and post 4 weeks of placebo.Carotid chemosensitivity examined by measuring hypoxia ventilatory responsiveness in older adults before and after 4 weeks of beet root juice supplementation and placebo. Chemoreflex sensitivity was quantified as the change in ventilation in relation to the change in pulse oxygen saturation.
Outcome measures
| Measure |
Nitrate Pre
n=13 Participants
Subjects randomized to the nitrate group for 4 weeks. Values reflect pre intervention measures.
|
Nitrate Post
n=13 Participants
Subjects randomized to the nitrate group for 4 weeks. Values reflect post intervention measures.
|
Placebo Pre
n=13 Participants
Subjects randomized to the placebo group for 4 weeks. Values reflect pre intervention measures.
|
Placebo Post
n=13 Participants
Subjects randomized to the placebo group for 4 weeks. Values reflect post intervention measures.
|
|---|---|---|---|---|
|
Change in Carotid Chemosensitivity Following 4 Weeks of Dietary Nitrate Supplementation and Placebo in Older Adults
|
-0.13 L/min/%SpO2
Standard Error 0.04
|
-0.05 L/min/%SpO2
Standard Error 0.02
|
-0.10 L/min/%SpO2
Standard Error 0.05
|
-0.11 L/min/%SpO2
Standard Error 0.05
|
PRIMARY outcome
Timeframe: Pre and post 4 weeks dietary nitrate supplementation and pre and post 4 weeks of placebo.Muscle metaboreflex examined by measuring systolic blood pressure responses to ischemic isometric muscle contraction in older adults before and after 4 weeks of beet root juice supplementation and placebo.
Outcome measures
| Measure |
Nitrate Pre
n=13 Participants
Subjects randomized to the nitrate group for 4 weeks. Values reflect pre intervention measures.
|
Nitrate Post
n=13 Participants
Subjects randomized to the nitrate group for 4 weeks. Values reflect post intervention measures.
|
Placebo Pre
n=13 Participants
Subjects randomized to the placebo group for 4 weeks. Values reflect pre intervention measures.
|
Placebo Post
n=13 Participants
Subjects randomized to the placebo group for 4 weeks. Values reflect post intervention measures.
|
|---|---|---|---|---|
|
Change in Systolic Blood Pressure During Metaboreflex Testing Following 4 Weeks of Dietary Nitrate Supplementation and Placebo in Older Adults.
|
19.2 mmHg
Standard Error 2.1
|
13 mmHg
Standard Error 2.5
|
16.1 mmHg
Standard Error 1.8
|
17 mmHg
Standard Error 1.9
|
Adverse Events
Nitrate
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
Young Comparison Group
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