Trial Outcomes & Findings for Obesity and Asthma: Nutrigenetic Response to Omega-3 Fatty Acids (NCT NCT01027143)
NCT ID: NCT01027143
Last Updated: 2023-09-08
Results Overview
The ACQ ranges from 0 to 6 (higher values indicate worse asthma control). A score greater than 1.25 in children is considered poor asthma control, and a change of 0.4 or greater is considered clinical meaningful.
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
143 participants
Primary outcome timeframe
baseline, 3 months, 6 months
Results posted on
2023-09-08
Participant Flow
30 were excluded due to medical history and 15 was lost to follow-up during run-in.
Participant milestones
| Measure |
Omega-3 Fatty Acids
3 softgels (EPA, DHA) twice daily
omega-3 polyunsaturated fatty acids: ProEPA Xtra 1000mg softgels: 3 softgels twice daily
|
Control
Soybean oil: 3 matched softgel caps twice daily
Omega-3 Fatty Acid: Soybean oil: 3(age 12-25) matched softgel caps twice daily
|
|---|---|---|
|
Overall Study
STARTED
|
77
|
21
|
|
Overall Study
COMPLETED
|
68
|
17
|
|
Overall Study
NOT COMPLETED
|
9
|
4
|
Reasons for withdrawal
| Measure |
Omega-3 Fatty Acids
3 softgels (EPA, DHA) twice daily
omega-3 polyunsaturated fatty acids: ProEPA Xtra 1000mg softgels: 3 softgels twice daily
|
Control
Soybean oil: 3 matched softgel caps twice daily
Omega-3 Fatty Acid: Soybean oil: 3(age 12-25) matched softgel caps twice daily
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
9
|
4
|
Baseline Characteristics
Obesity and Asthma: Nutrigenetic Response to Omega-3 Fatty Acids
Baseline characteristics by cohort
| Measure |
Omega-3 Fatty Acids
n=77 Participants
3 softgels (EPA, DHA) twice daily
omega-3 polyunsaturated fatty acids: ProEPA Xtra 1000mg softgels: 3 softgels twice daily
|
Control
n=21 Participants
Soybean oil: 3 matched softgel caps twice daily
Omega-3 Fatty Acid: Soybean oil: 3(age 12-25) matched softgel caps twice daily
|
Total
n=98 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
14.6 years
STANDARD_DEVIATION 2.2 • n=5 Participants
|
14.6 years
STANDARD_DEVIATION 2.2 • n=7 Participants
|
14.6 years
STANDARD_DEVIATION 2.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
40 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
37 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
20 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
57 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
71 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 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
|
40 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
30 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
39 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
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
77 participants
n=5 Participants
|
21 participants
n=7 Participants
|
98 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: baseline, 3 months, 6 monthsThe ACQ ranges from 0 to 6 (higher values indicate worse asthma control). A score greater than 1.25 in children is considered poor asthma control, and a change of 0.4 or greater is considered clinical meaningful.
Outcome measures
| Measure |
Omega-3 Fatty Acids
n=77 Participants
3 softgels (EPA, DHA) twice daily
omega-3 polyunsaturated fatty acids: ProEPA Xtra 1000mg softgels: 3 softgels twice daily
|
Control
n=21 Participants
Soybean oil: 3 matched softgel caps twice daily
Omega-3 Fatty Acid: Soybean oil: 3(age 12-25) matched softgel caps twice daily
|
|---|---|---|
|
Asthma Control Questionnaire (Juniper)
Baseline
|
1.13 score on a scale
Interval 0.95 to 1.31
|
1.08 score on a scale
Interval 0.78 to 1.39
|
|
Asthma Control Questionnaire (Juniper)
Change at 3 months
|
-0.08 score on a scale
Interval -0.25 to 0.08
|
-0.09 score on a scale
Interval -0.52 to 0.33
|
|
Asthma Control Questionnaire (Juniper)
Change at 6 months
|
-0.09 score on a scale
Interval -0.29 to 0.1
|
-0.18 score on a scale
Interval -0.42 to 0.07
|
SECONDARY outcome
Timeframe: Baseline, 3 and 6 monthsPopulation: Blood was not successfully drawn in all children
Ratio of total omega-3 to total omega-6 polyunsaturated fatty acids from granulocytes in peripheral blood
Outcome measures
| Measure |
Omega-3 Fatty Acids
n=77 Participants
3 softgels (EPA, DHA) twice daily
omega-3 polyunsaturated fatty acids: ProEPA Xtra 1000mg softgels: 3 softgels twice daily
|
Control
n=21 Participants
Soybean oil: 3 matched softgel caps twice daily
Omega-3 Fatty Acid: Soybean oil: 3(age 12-25) matched softgel caps twice daily
|
|---|---|---|
|
N3-to-n6 PUFA Ratio (Granulocytes)
Baseline
|
0.06 no units (ratio)
Interval 0.03 to 0.08
|
0.10 no units (ratio)
Interval 0.05 to 0.14
|
|
N3-to-n6 PUFA Ratio (Granulocytes)
3 months
|
0.19 no units (ratio)
Interval 0.09 to 0.28
|
0.08 no units (ratio)
Interval 0.03 to 0.14
|
|
N3-to-n6 PUFA Ratio (Granulocytes)
6 months
|
0.17 no units (ratio)
Interval 0.1 to 0.24
|
0.08 no units (ratio)
Interval 0.02 to 0.14
|
SECONDARY outcome
Timeframe: Baseline, 3 months, 6 monthsPopulation: blood was not successfully drawn in all children
Ratio of total omega-3 to total omega-6 polyunsaturated fatty acids from monocytes in peripheral blood
Outcome measures
| Measure |
Omega-3 Fatty Acids
n=77 Participants
3 softgels (EPA, DHA) twice daily
omega-3 polyunsaturated fatty acids: ProEPA Xtra 1000mg softgels: 3 softgels twice daily
|
Control
n=21 Participants
Soybean oil: 3 matched softgel caps twice daily
Omega-3 Fatty Acid: Soybean oil: 3(age 12-25) matched softgel caps twice daily
|
|---|---|---|
|
N3-to-n6 PUFA Ratio (Monocytes)
Baseline
|
0.04 no units (ratio)
Interval 0.03 to 0.05
|
0.08 no units (ratio)
Interval 0.03 to 0.14
|
|
N3-to-n6 PUFA Ratio (Monocytes)
3 months
|
0.11 no units (ratio)
Interval 0.07 to 0.15
|
0.05 no units (ratio)
Interval 0.02 to 0.08
|
|
N3-to-n6 PUFA Ratio (Monocytes)
6 months
|
0.12 no units (ratio)
Interval 0.07 to 0.18
|
0.07 no units (ratio)
Interval 0.03 to 0.11
|
SECONDARY outcome
Timeframe: Baseline, 3 months, 6 monthsPopulation: missing data due to drop outs or staff error
The asthma control test assesses patient reported symptoms from the prior month and has a range from 5 to 25 with a higher score suggesting better asthma control.
Outcome measures
| Measure |
Omega-3 Fatty Acids
n=77 Participants
3 softgels (EPA, DHA) twice daily
omega-3 polyunsaturated fatty acids: ProEPA Xtra 1000mg softgels: 3 softgels twice daily
|
Control
n=21 Participants
Soybean oil: 3 matched softgel caps twice daily
Omega-3 Fatty Acid: Soybean oil: 3(age 12-25) matched softgel caps twice daily
|
|---|---|---|
|
Asthma Control Test
Baseline
|
19.4 units on a scale
Interval 18.5 to 20.2
|
19.9 units on a scale
Interval 18.2 to 21.6
|
|
Asthma Control Test
3 months
|
19.5 units on a scale
Interval 18.6 to 20.3
|
20.3 units on a scale
Interval 17.8 to 22.8
|
|
Asthma Control Test
6 months
|
20.2 units on a scale
Interval 19.3 to 21.1
|
20.4 units on a scale
Interval 18.0 to 22.7
|
SECONDARY outcome
Timeframe: Baseline, 3 months, 6 monthsPopulation: missing data resulted from participants lost to follow up or not providing urine samples
Leukotriene E4 obtained from urine was measured using liquid chromatography tandem mass spectrometry.
Outcome measures
| Measure |
Omega-3 Fatty Acids
n=77 Participants
3 softgels (EPA, DHA) twice daily
omega-3 polyunsaturated fatty acids: ProEPA Xtra 1000mg softgels: 3 softgels twice daily
|
Control
n=21 Participants
Soybean oil: 3 matched softgel caps twice daily
Omega-3 Fatty Acid: Soybean oil: 3(age 12-25) matched softgel caps twice daily
|
|---|---|---|
|
Urinary Leukotriene-E4
Baseline
|
70.1 pg/mg creatinine
Interval 59.7 to 80.5
|
84.0 pg/mg creatinine
Interval 60.1 to 107.9
|
|
Urinary Leukotriene-E4
3 months
|
78.5 pg/mg creatinine
Interval 64.6 to 92.3
|
61.3 pg/mg creatinine
Interval 41.4 to 81.1
|
|
Urinary Leukotriene-E4
6 months
|
80.6 pg/mg creatinine
Interval 67.9 to 93.3
|
66.5 pg/mg creatinine
Interval 43.0 to 90.0
|
SECONDARY outcome
Timeframe: Baseline, 3 months, 6 monthsPopulation: missing data due to participants lost to follow-up or not being able to provide valid spirometry
Forced expiratory volume in 1 second is a validated spirometry measure.
Outcome measures
| Measure |
Omega-3 Fatty Acids
n=77 Participants
3 softgels (EPA, DHA) twice daily
omega-3 polyunsaturated fatty acids: ProEPA Xtra 1000mg softgels: 3 softgels twice daily
|
Control
n=21 Participants
Soybean oil: 3 matched softgel caps twice daily
Omega-3 Fatty Acid: Soybean oil: 3(age 12-25) matched softgel caps twice daily
|
|---|---|---|
|
FEV1
Baseline
|
90.2 percent of predicted
Interval 86.7 to 93.8
|
90.3 percent of predicted
Interval 84.4 to 96.2
|
|
FEV1
3 months
|
91.6 percent of predicted
Interval 88.7 to 94.6
|
90.2 percent of predicted
Interval 84.1 to 96.3
|
|
FEV1
6 months
|
91.6 percent of predicted
Interval 87.4 to 95.8
|
91.7 percent of predicted
Interval 85.2 to 98.2
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: all randomized participants
Exacerbations of asthma were defined by the need for urgent medical care (emergency room or urgent care clinic) or systemic corticosteroids to avoid severe worsening of asthma determined by study physician or local provider
Outcome measures
| Measure |
Omega-3 Fatty Acids
n=77 Participants
3 softgels (EPA, DHA) twice daily
omega-3 polyunsaturated fatty acids: ProEPA Xtra 1000mg softgels: 3 softgels twice daily
|
Control
n=21 Participants
Soybean oil: 3 matched softgel caps twice daily
Omega-3 Fatty Acid: Soybean oil: 3(age 12-25) matched softgel caps twice daily
|
|---|---|---|
|
Exacerbations
|
17 exacerbations
|
5 exacerbations
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: all randomized participants
Phone contact was defined as an urgent or unscheduled phone contact to a medical provider for asthma
Outcome measures
| Measure |
Omega-3 Fatty Acids
n=77 Participants
3 softgels (EPA, DHA) twice daily
omega-3 polyunsaturated fatty acids: ProEPA Xtra 1000mg softgels: 3 softgels twice daily
|
Control
n=21 Participants
Soybean oil: 3 matched softgel caps twice daily
Omega-3 Fatty Acid: Soybean oil: 3(age 12-25) matched softgel caps twice daily
|
|---|---|---|
|
Phone Contacts
|
10 events
|
6 events
|
Adverse Events
Omega-3 Fatty Acids
Serious events: 3 serious events
Other events: 58 other events
Deaths: 0 deaths
Control
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Omega-3 Fatty Acids
n=77 participants at risk
3 softgels (EPA, DHA) twice daily
omega-3 polyunsaturated fatty acids: ProEPA Xtra 1000mg softgels: 3 softgels twice daily
|
Control
n=21 participants at risk
Soybean oil: 3 matched softgel caps twice daily
Omega-3 Fatty Acid: Soybean oil: 3(age 12-25) matched softgel caps twice daily
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
asthma exacerbation
|
2.6%
2/77 • Number of events 2 • Over the course of the study post randomization (24 weeks)
Our adverse event and serious adverse event did not differ from the definitions outlined in clinicaltrials.gov.
|
0.00%
0/21 • Over the course of the study post randomization (24 weeks)
Our adverse event and serious adverse event did not differ from the definitions outlined in clinicaltrials.gov.
|
|
Gastrointestinal disorders
vomiting
|
1.3%
1/77 • Number of events 1 • Over the course of the study post randomization (24 weeks)
Our adverse event and serious adverse event did not differ from the definitions outlined in clinicaltrials.gov.
|
0.00%
0/21 • Over the course of the study post randomization (24 weeks)
Our adverse event and serious adverse event did not differ from the definitions outlined in clinicaltrials.gov.
|
Other adverse events
| Measure |
Omega-3 Fatty Acids
n=77 participants at risk
3 softgels (EPA, DHA) twice daily
omega-3 polyunsaturated fatty acids: ProEPA Xtra 1000mg softgels: 3 softgels twice daily
|
Control
n=21 participants at risk
Soybean oil: 3 matched softgel caps twice daily
Omega-3 Fatty Acid: Soybean oil: 3(age 12-25) matched softgel caps twice daily
|
|---|---|---|
|
Nervous system disorders
Headaches
|
50.6%
39/77 • Over the course of the study post randomization (24 weeks)
Our adverse event and serious adverse event did not differ from the definitions outlined in clinicaltrials.gov.
|
38.1%
8/21 • Over the course of the study post randomization (24 weeks)
Our adverse event and serious adverse event did not differ from the definitions outlined in clinicaltrials.gov.
|
|
Immune system disorders
Dry Mouth
|
18.2%
14/77 • Over the course of the study post randomization (24 weeks)
Our adverse event and serious adverse event did not differ from the definitions outlined in clinicaltrials.gov.
|
23.8%
5/21 • Over the course of the study post randomization (24 weeks)
Our adverse event and serious adverse event did not differ from the definitions outlined in clinicaltrials.gov.
|
|
Gastrointestinal disorders
Nausea
|
27.3%
21/77 • Over the course of the study post randomization (24 weeks)
Our adverse event and serious adverse event did not differ from the definitions outlined in clinicaltrials.gov.
|
19.0%
4/21 • Over the course of the study post randomization (24 weeks)
Our adverse event and serious adverse event did not differ from the definitions outlined in clinicaltrials.gov.
|
|
Gastrointestinal disorders
Bloating
|
14.3%
11/77 • Over the course of the study post randomization (24 weeks)
Our adverse event and serious adverse event did not differ from the definitions outlined in clinicaltrials.gov.
|
9.5%
2/21 • Over the course of the study post randomization (24 weeks)
Our adverse event and serious adverse event did not differ from the definitions outlined in clinicaltrials.gov.
|
|
Gastrointestinal disorders
Diarrhea
|
14.3%
11/77 • Over the course of the study post randomization (24 weeks)
Our adverse event and serious adverse event did not differ from the definitions outlined in clinicaltrials.gov.
|
23.8%
5/21 • Over the course of the study post randomization (24 weeks)
Our adverse event and serious adverse event did not differ from the definitions outlined in clinicaltrials.gov.
|
|
Gastrointestinal disorders
Constipation
|
10.4%
8/77 • Over the course of the study post randomization (24 weeks)
Our adverse event and serious adverse event did not differ from the definitions outlined in clinicaltrials.gov.
|
9.5%
2/21 • Over the course of the study post randomization (24 weeks)
Our adverse event and serious adverse event did not differ from the definitions outlined in clinicaltrials.gov.
|
|
Gastrointestinal disorders
Flatulence
|
18.2%
14/77 • Over the course of the study post randomization (24 weeks)
Our adverse event and serious adverse event did not differ from the definitions outlined in clinicaltrials.gov.
|
23.8%
5/21 • Over the course of the study post randomization (24 weeks)
Our adverse event and serious adverse event did not differ from the definitions outlined in clinicaltrials.gov.
|
|
Skin and subcutaneous tissue disorders
Rash
|
19.5%
15/77 • Over the course of the study post randomization (24 weeks)
Our adverse event and serious adverse event did not differ from the definitions outlined in clinicaltrials.gov.
|
9.5%
2/21 • Over the course of the study post randomization (24 weeks)
Our adverse event and serious adverse event did not differ from the definitions outlined in clinicaltrials.gov.
|
|
Respiratory, thoracic and mediastinal disorders
URI
|
40.3%
31/77 • Over the course of the study post randomization (24 weeks)
Our adverse event and serious adverse event did not differ from the definitions outlined in clinicaltrials.gov.
|
38.1%
8/21 • Over the course of the study post randomization (24 weeks)
Our adverse event and serious adverse event did not differ from the definitions outlined in clinicaltrials.gov.
|
|
Respiratory, thoracic and mediastinal disorders
Sore Throat
|
26.0%
20/77 • Over the course of the study post randomization (24 weeks)
Our adverse event and serious adverse event did not differ from the definitions outlined in clinicaltrials.gov.
|
38.1%
8/21 • Over the course of the study post randomization (24 weeks)
Our adverse event and serious adverse event did not differ from the definitions outlined in clinicaltrials.gov.
|
|
Respiratory, thoracic and mediastinal disorders
Sinusitis
|
11.7%
9/77 • Over the course of the study post randomization (24 weeks)
Our adverse event and serious adverse event did not differ from the definitions outlined in clinicaltrials.gov.
|
4.8%
1/21 • Over the course of the study post randomization (24 weeks)
Our adverse event and serious adverse event did not differ from the definitions outlined in clinicaltrials.gov.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place