Trial Outcomes & Findings for The Effects of NOx and Conjugated Linoleic Acid on Asthmatics (NCT NCT02433977)

NCT ID: NCT02433977

Last Updated: 2021-04-27

Results Overview

Determine how CLA and NOx affect airway NO bioavailability (exhaled NO)

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

6 participants

Primary outcome timeframe

Before treatment at baseline and after treatment at 8 weeks

Results posted on

2021-04-27

Participant Flow

Participant milestones

Participant milestones
Measure	Conjugated Linolenic Acid + NOx This is a single arm study Conjugated Linolenic Acid (CLA)- daily oral dose 3 g/day Sodium Nitrate- Capsules for daily oral administration at the dose of 1 g (2 x 500 mg) Sodium Nitrite- Capsules for daily oral administration at the dose of 20 mg (2 x 10 mg) Conjugated Linolenic Acid: CLA is a polyunsaturated fatty acid Subjects will receive capsules for daily oral administration at the dose of 3 g/day Sodium Nitrite: Subjects will receive capsules for daily oral administration at the dose of 20 mg (2 x 10 mg) Sodium Nitrate: Subjects will receive capsules for daily oral administration at the dose of 1g (2 x 500 mg)
Overall Study STARTED	6
Overall Study COMPLETED	6
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The Effects of NOx and Conjugated Linoleic Acid on Asthmatics

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Conjugated Linolenic Acid + NOx n=6 Participants This is a single arm study Conjugated Linolenic Acid (CLA)- daily oral dose 3 g/day Sodium Nitrate- Capsules for daily oral administration at the dose of 1 g (2 x 500 mg) Sodium Nitrite- Capsules for daily oral administration at the dose of 20 mg (2 x 10 mg) Conjugated Linolenic Acid: CLA is a polyunsaturated fatty acid Subjects will receive capsules for daily oral administration at the dose of 3 g/day Sodium Nitrite: Subjects will receive capsules for daily oral administration at the dose of 20 mg (2 x 10 mg) Sodium Nitrate: Subjects will receive capsules for daily oral administration at the dose of 1g (2 x 500 mg)
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	6 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	40.5 years STANDARD_DEVIATION 10.3 • n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	6 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	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	2 Participants n=5 Participants
Race (NIH/OMB) White	4 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	6 participants n=5 Participants

PRIMARY outcome

Timeframe: Before treatment at baseline and after treatment at 8 weeks

Determine how CLA and NOx affect airway NO bioavailability (exhaled NO)

Outcome measures

Outcome measures
Measure	Conjugated Linolenic Acid + NOx n=6 Participants This is a single arm study Conjugated Linolenic Acid (CLA)- daily oral dose 3 g/day Sodium Nitrate- Capsules for daily oral administration at the dose of 1 g (2 x 500 mg) Sodium Nitrite- Capsules for daily oral administration at the dose of 20 mg (2 x 10 mg) Conjugated Linolenic Acid: CLA is a polyunsaturated fatty acid Subjects will receive capsules for daily oral administration at the dose of 3 g/day Sodium Nitrite: Subjects will receive capsules for daily oral administration at the dose of 20 mg (2 x 10 mg) Sodium Nitrate: Subjects will receive capsules for daily oral administration at the dose of 1g (2 x 500 mg)
Change in Exhaled NO Before and After Treatment	39.5 parts per billion Standard Deviation 10.4

SECONDARY outcome

Timeframe: Before treatment at baseline and after treatment at 8 weeks

To determine whether, compared to baseline, treatment with NOx + CLA can reduce bronchial hyperresponsiveness. PC20 was measured by methacholine challenge (mg/mL) in three participants pre and post supplementation with Nitrate/Nitrite and cLA

Outcome measures

Outcome measures
Measure	Conjugated Linolenic Acid + NOx n=3 Participants This is a single arm study Conjugated Linolenic Acid (CLA)- daily oral dose 3 g/day Sodium Nitrate- Capsules for daily oral administration at the dose of 1 g (2 x 500 mg) Sodium Nitrite- Capsules for daily oral administration at the dose of 20 mg (2 x 10 mg) Conjugated Linolenic Acid: CLA is a polyunsaturated fatty acid Subjects will receive capsules for daily oral administration at the dose of 3 g/day Sodium Nitrite: Subjects will receive capsules for daily oral administration at the dose of 20 mg (2 x 10 mg) Sodium Nitrate: Subjects will receive capsules for daily oral administration at the dose of 1g (2 x 500 mg)
Biomarkers of Inflammation-bronchial Hyperresponsiveness Using PC20	10.33 mg/mL Standard Deviation 12.74

SECONDARY outcome

Timeframe: Before treatment at baseline and after treatment at 8 weeks

To determine whether, compared to baseline, treatment with NOx + CLA can quantify the concentrations of free CLA in plasma

Outcome measures

Outcome measures
Measure	Conjugated Linolenic Acid + NOx n=6 Participants This is a single arm study Conjugated Linolenic Acid (CLA)- daily oral dose 3 g/day Sodium Nitrate- Capsules for daily oral administration at the dose of 1 g (2 x 500 mg) Sodium Nitrite- Capsules for daily oral administration at the dose of 20 mg (2 x 10 mg) Conjugated Linolenic Acid: CLA is a polyunsaturated fatty acid Subjects will receive capsules for daily oral administration at the dose of 3 g/day Sodium Nitrite: Subjects will receive capsules for daily oral administration at the dose of 20 mg (2 x 10 mg) Sodium Nitrate: Subjects will receive capsules for daily oral administration at the dose of 1g (2 x 500 mg)
Biomarkers of Inflammation- Concentration of Free CLA in Plasma	161.8 Nanomolar Standard Deviation 44.3

SECONDARY outcome

Timeframe: Before treatment at baseline and after treatment at 8 weeks

To determine whether, compared to baseline, treatment with NOx + CLA will increase a participant's IL-6 and IL-1b expression.

Outcome measures

Outcome measures
Measure	Conjugated Linolenic Acid + NOx n=6 Participants This is a single arm study Conjugated Linolenic Acid (CLA)- daily oral dose 3 g/day Sodium Nitrate- Capsules for daily oral administration at the dose of 1 g (2 x 500 mg) Sodium Nitrite- Capsules for daily oral administration at the dose of 20 mg (2 x 10 mg) Conjugated Linolenic Acid: CLA is a polyunsaturated fatty acid Subjects will receive capsules for daily oral administration at the dose of 3 g/day Sodium Nitrite: Subjects will receive capsules for daily oral administration at the dose of 20 mg (2 x 10 mg) Sodium Nitrate: Subjects will receive capsules for daily oral administration at the dose of 1g (2 x 500 mg)
Number of Participants With an Increase in IL-6 and IL-1b Expression	5 Participants

SECONDARY outcome

Timeframe: Before treatment at baseline and after treatment at 8 weeks

Population: Data were not collected for this Outcome Measure. The proposed aims could not be addressed with scientific rigor since the number of subjects who completed the study was very low.

To determine whether, compared to baseline, treatment with NOx + CLA can effect airway XO activity determined in endobronchial biopsies

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Before treatment at baseline and after treatment at 8 weeks

To determine whether, compared to baseline, treatment with NOx + CLA can effect measurement of 15NO2-cLA in urine.

Outcome measures

Outcome measures
Measure	Conjugated Linolenic Acid + NOx n=6 Participants This is a single arm study Conjugated Linolenic Acid (CLA)- daily oral dose 3 g/day Sodium Nitrate- Capsules for daily oral administration at the dose of 1 g (2 x 500 mg) Sodium Nitrite- Capsules for daily oral administration at the dose of 20 mg (2 x 10 mg) Conjugated Linolenic Acid: CLA is a polyunsaturated fatty acid Subjects will receive capsules for daily oral administration at the dose of 3 g/day Sodium Nitrite: Subjects will receive capsules for daily oral administration at the dose of 20 mg (2 x 10 mg) Sodium Nitrate: Subjects will receive capsules for daily oral administration at the dose of 1g (2 x 500 mg)
Biomarkers of Inflammation-15NO2-cLA	9.32 nmoles/mg creatinine Standard Deviation 8.9

SECONDARY outcome

Timeframe: Before treatment at baseline and after treatment at 8 weeks

Population: Data were not collected for this Outcome Measure. The proposed aims could not be addressed with scientific rigor since the number of subjects who completed the study was very low.

To determine whether, compared to baseline, treatment with NOx + CLA can decrease production of anion superoxide in fresh airway epithelial cells

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Before treatment at baseline and after treatment at 8 weeks

To determine whether, compared to baseline, treatment with NOx + CLA can decrease inflammation using mitochondrial ROS production in fresh and cultured airway epithelial cells.

Outcome measures

Outcome measures
Measure	Conjugated Linolenic Acid + NOx n=6 Participants This is a single arm study Conjugated Linolenic Acid (CLA)- daily oral dose 3 g/day Sodium Nitrate- Capsules for daily oral administration at the dose of 1 g (2 x 500 mg) Sodium Nitrite- Capsules for daily oral administration at the dose of 20 mg (2 x 10 mg) Conjugated Linolenic Acid: CLA is a polyunsaturated fatty acid Subjects will receive capsules for daily oral administration at the dose of 3 g/day Sodium Nitrite: Subjects will receive capsules for daily oral administration at the dose of 20 mg (2 x 10 mg) Sodium Nitrate: Subjects will receive capsules for daily oral administration at the dose of 1g (2 x 500 mg)
Number of Participants With a Decrease of Inflammation Using Mitochondrial ROS Production	0 Participants

SECONDARY outcome

Timeframe: Before treatment at baseline and after treatment at 8 weeks

To determine whether, compared to baseline, treatment with NOx + CLA can quantify the concentrations of NO2-cLA in plasma

Outcome measures

Outcome measures
Measure	Conjugated Linolenic Acid + NOx n=6 Participants This is a single arm study Conjugated Linolenic Acid (CLA)- daily oral dose 3 g/day Sodium Nitrate- Capsules for daily oral administration at the dose of 1 g (2 x 500 mg) Sodium Nitrite- Capsules for daily oral administration at the dose of 20 mg (2 x 10 mg) Conjugated Linolenic Acid: CLA is a polyunsaturated fatty acid Subjects will receive capsules for daily oral administration at the dose of 3 g/day Sodium Nitrite: Subjects will receive capsules for daily oral administration at the dose of 20 mg (2 x 10 mg) Sodium Nitrate: Subjects will receive capsules for daily oral administration at the dose of 1g (2 x 500 mg)
Biomarkers of Inflammation- Concentration of NO2-CLA in Plasma	5.65 Nanomolar Standard Deviation 1.48

SECONDARY outcome

Timeframe: Before treatment at baseline and after treatment at 8 weeks

To determine whether, compared to baseline, treatment with NOx + CLA can quantify the concentrations of NO2-cLA in urine

Outcome measures

Outcome measures
Measure	Conjugated Linolenic Acid + NOx n=6 Participants This is a single arm study Conjugated Linolenic Acid (CLA)- daily oral dose 3 g/day Sodium Nitrate- Capsules for daily oral administration at the dose of 1 g (2 x 500 mg) Sodium Nitrite- Capsules for daily oral administration at the dose of 20 mg (2 x 10 mg) Conjugated Linolenic Acid: CLA is a polyunsaturated fatty acid Subjects will receive capsules for daily oral administration at the dose of 3 g/day Sodium Nitrite: Subjects will receive capsules for daily oral administration at the dose of 20 mg (2 x 10 mg) Sodium Nitrate: Subjects will receive capsules for daily oral administration at the dose of 1g (2 x 500 mg)
Biomarkers of Inflammation- Concentration of NO2-CLA in Urine	4.33 nmoles/mg creatinine Standard Deviation 1.8

Adverse Events

Conjugated Linolenic Acid + NOx

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Conjugated Linolenic Acid + NOx n=6 participants at risk This is a single arm study Conjugated Linolenic Acid (CLA)- daily oral dose 3 g/day Sodium Nitrate- Capsules for daily oral administration at the dose of 1 g (2 x 500 mg) Sodium Nitrite- Capsules for daily oral administration at the dose of 20 mg (2 x 10 mg) Conjugated Linolenic Acid: CLA is a polyunsaturated fatty acid Subjects will receive capsules for daily oral administration at the dose of 3 g/day Sodium Nitrite: Subjects will receive capsules for daily oral administration at the dose of 20 mg (2 x 10 mg) Sodium Nitrate: Subjects will receive capsules for daily oral administration at the dose of 1g (2 x 500 mg)
General disorders Headache	100.0% 6/6 • Before treatment at baseline through completion of treatment at 8 weeks The occurrence of adverse events was routinely determined through regular investigator/research coordinator assessment.
Gastrointestinal disorders Nausea	100.0% 6/6 • Before treatment at baseline through completion of treatment at 8 weeks The occurrence of adverse events was routinely determined through regular investigator/research coordinator assessment.

Additional Information

Stacy Gelhaus Wendell

University of Pittsburgh

Phone: 412-648-1351

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place