Trial Outcomes & Findings for Effect of Dietary Supplemental Fish Oil in Alleviating Health Hazards Associated With Air Pollution (NCT NCT03255187)
NCT ID: NCT03255187
Last Updated: 2024-04-23
Results Overview
Peripheral blood samples (5 ml) were drawn, separated into serum, and stored at -80 ℃ within 30 minutes. We also measure GSH-Px. The values in the following Outcome Measure Data Table refer to the means of measurements at 4 follow-ups.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
70 participants
Primary outcome timeframe
Blood samples are obtained at the end of each round of 4 follow-ups with an interval of 2 weeks in the last 2 months of intervention.
Results posted on
2024-04-23
Participant Flow
Recruitment was conducted on Agust, 2017 in Fenglin Campus, Fudan University. A total of 93 participants were assessed for eligibility and 70 of them were finally recruited.
Participant milestones
| Measure |
Fish Oil Supplementation
This group receive 2.5 g/day (two 1.25-g capsules daily) of fish oil (marine-derived n-3 PUFA) for 4 consecutive months.
Fish oil supplementation: Participants of this randomized double-blind placebo-controlled trial include 70 healthy Chinese adults. The investigators randomly assign participants to two parallel groups at baseline using a random-number table. Compliance is determined by directly observed supplement intake. Participants in fish oil group are assigned to receive 2.5 g/day in divided doses. Each capsule contains 60% n-3 PUFA \[24% docosahexanoic acid (C22:6 n-3 DHA) and 36% eicosapentaenoic acid (C20:5 n-3 EPA)\].
|
Sunflower Seed Oil Supplementation
This group receive 2.5 g/day (two 1.25-g capsules daily) of placebo (sunflower seed oil) for 4 consecutive months.
Sunflower seed oil supplementation: Participants of this randomized double-blind placebo-controlled trial include 70 healthy Chinese adults. The investigators randomly assign participants to two parallel groups at baseline using a random-number table. Compliance is determined by directly observed supplement intake. Participants in sunflower seed oil group receive 2.5 g/day in divided doses, and the capsules are identical as the fish oil capsules. Each capsule containes 14.4% palmitic acid (C16:0), 16.0% oleic acid (C18:1 n-9), and 57.6% linoleic acid (C18:2 n-6).
|
|---|---|---|
|
Periodfrom Enrollment to First Follow-up
STARTED
|
35
|
35
|
|
Periodfrom Enrollment to First Follow-up
COMPLETED
|
34
|
32
|
|
Periodfrom Enrollment to First Follow-up
NOT COMPLETED
|
1
|
3
|
|
Period From First to Second Follow-up
STARTED
|
34
|
32
|
|
Period From First to Second Follow-up
COMPLETED
|
34
|
31
|
|
Period From First to Second Follow-up
NOT COMPLETED
|
0
|
1
|
|
Period From Second to Third Follow-up
STARTED
|
34
|
31
|
|
Period From Second to Third Follow-up
COMPLETED
|
34
|
31
|
|
Period From Second to Third Follow-up
NOT COMPLETED
|
0
|
0
|
|
Period From Third to Fourth Follow-up
STARTED
|
34
|
31
|
|
Period From Third to Fourth Follow-up
COMPLETED
|
34
|
31
|
|
Period From Third to Fourth Follow-up
NOT COMPLETED
|
0
|
0
|
|
Period at Fourth Follow-up
STARTED
|
34
|
31
|
|
Period at Fourth Follow-up
COMPLETED
|
34
|
31
|
|
Period at Fourth Follow-up
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
Fish Oil Supplementation
This group receive 2.5 g/day (two 1.25-g capsules daily) of fish oil (marine-derived n-3 PUFA) for 4 consecutive months.
Fish oil supplementation: Participants of this randomized double-blind placebo-controlled trial include 70 healthy Chinese adults. The investigators randomly assign participants to two parallel groups at baseline using a random-number table. Compliance is determined by directly observed supplement intake. Participants in fish oil group are assigned to receive 2.5 g/day in divided doses. Each capsule contains 60% n-3 PUFA \[24% docosahexanoic acid (C22:6 n-3 DHA) and 36% eicosapentaenoic acid (C20:5 n-3 EPA)\].
|
Sunflower Seed Oil Supplementation
This group receive 2.5 g/day (two 1.25-g capsules daily) of placebo (sunflower seed oil) for 4 consecutive months.
Sunflower seed oil supplementation: Participants of this randomized double-blind placebo-controlled trial include 70 healthy Chinese adults. The investigators randomly assign participants to two parallel groups at baseline using a random-number table. Compliance is determined by directly observed supplement intake. Participants in sunflower seed oil group receive 2.5 g/day in divided doses, and the capsules are identical as the fish oil capsules. Each capsule containes 14.4% palmitic acid (C16:0), 16.0% oleic acid (C18:1 n-9), and 57.6% linoleic acid (C18:2 n-6).
|
|---|---|---|
|
Periodfrom Enrollment to First Follow-up
Withdrawal by Subject
|
1
|
3
|
|
Period From First to Second Follow-up
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
Effect of Dietary Supplemental Fish Oil in Alleviating Health Hazards Associated With Air Pollution
Baseline characteristics by cohort
| Measure |
Fish Oil Supplementation
n=34 Participants
This group receive 2.5 g/day (two 1.25-g capsules daily) of fish oil (marine-derived n-3 PUFA) for 4 consecutive months.
Fish oil supplementation: Participants of this randomized double-blind placebo-controlled trial include 70 healthy Chinese adults. The investigators randomly assign participants to two parallel groups at baseline using a random-number table. Compliance is determined by directly observed supplement intake. Participants in fish oil group are assigned to receive 2.5 g/day in divided doses. Each capsule contains 60% n-3 PUFA \[24% docosahexanoic acid (C22:6 n-3 DHA) and 36% eicosapentaenoic acid (C20:5 n-3 EPA)\].
|
Sunflower Seed Oil Supplementation
n=31 Participants
This group receive 2.5 g/day (two 1.25-g capsules daily) of placebo (sunflower seed oil) for 4 consecutive months.
Sunflower seed oil supplementation: Participants of this randomized double-blind placebo-controlled trial include 70 healthy Chinese adults. The investigators randomly assign participants to two parallel groups at baseline using a random-number table. Compliance is determined by directly observed supplement intake. Participants in sunflower seed oil group receive 2.5 g/day in divided doses, and the capsules are identical as the fish oil capsules. Each capsule containes 14.4% palmitic acid (C16:0), 16.0% oleic acid (C18:1 n-9), and 57.6% linoleic acid (C18:2 n-6).
|
Total
n=65 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
23.03 years
STANDARD_DEVIATION 2.26 • n=5 Participants
|
22.87 years
STANDARD_DEVIATION 1.28 • n=7 Participants
|
22.95 years
STANDARD_DEVIATION 1.85 • n=5 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
27 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
|
34 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
65 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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
China
|
34 participants
n=5 Participants
|
31 participants
n=7 Participants
|
65 participants
n=5 Participants
|
|
Body mass index
|
21.73 kg/m^2
STANDARD_DEVIATION 3.23 • n=5 Participants
|
21.56 kg/m^2
STANDARD_DEVIATION 3.02 • n=7 Participants
|
21.65 kg/m^2
STANDARD_DEVIATION 3.10 • n=5 Participants
|
|
Physical activity
Never
|
31 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
58 Participants
n=5 Participants
|
|
Physical activity
Mild
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Physical activity
Moderate
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Physical activity
Vigorous
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Blood samples are obtained at the end of each round of 4 follow-ups with an interval of 2 weeks in the last 2 months of intervention.Peripheral blood samples (5 ml) were drawn, separated into serum, and stored at -80 ℃ within 30 minutes. We measure 2 biomarkers of antioxidant activity, including TAC and SOD. The values in the following Outcome Measure Data Table refer to the means of measurements at 4 follow-ups.
Outcome measures
| Measure |
Fish Oil Supplementation
n=34 Participants
This group receive 2.5 g/day (two 1.25-g capsules daily) of fish oil (marine-derived n-3 PUFA) for 4 consecutive months.
Fish oil supplementation: Participants of this randomized double-blind placebo-controlled trial include 70 healthy Chinese adults. The investigators randomly assign participants to two parallel groups at baseline using a random-number table. Compliance is determined by directly observed supplement intake. Participants in fish oil group are assigned to receive 2.5 g/day in divided doses. Each capsule contains 60% n-3 PUFA \[24% docosahexanoic acid (C22:6 n-3 DHA) and 36% eicosapentaenoic acid (C20:5 n-3 EPA)\].
|
Sunflower Seed Oil Supplementation
n=31 Participants
This group receive 2.5 g/day (two 1.25-g capsules daily) of placebo (sunflower seed oil) for 4 consecutive months.
Sunflower seed oil supplementation: Participants of this randomized double-blind placebo-controlled trial include 70 healthy Chinese adults. The investigators randomly assign participants to two parallel groups at baseline using a random-number table. Compliance is determined by directly observed supplement intake. Participants in sunflower seed oil group receive 2.5 g/day in divided doses, and the capsules are identical as the fish oil capsules. Each capsule containes 14.4% palmitic acid (C16:0), 16.0% oleic acid (C18:1 n-9), and 57.6% linoleic acid (C18:2 n-6).
|
|---|---|---|
|
Biomarkers of Antioxidant Activity-Total Antioxidant Capacity (TAC) and Superoxide Dismutase (SOD)
TAC
|
6.09 U/ml
Standard Deviation 2.15
|
5.80 U/ml
Standard Deviation 2.36
|
|
Biomarkers of Antioxidant Activity-Total Antioxidant Capacity (TAC) and Superoxide Dismutase (SOD)
SOD
|
364.34 U/ml
Standard Deviation 42.69
|
356.59 U/ml
Standard Deviation 43.90
|
PRIMARY outcome
Timeframe: Blood samples are obtained at the end of each round of 4 follow-ups with an interval of 2 weeks in the last 2 months of intervention.2 inflammatory biomarkers in our study including IL-6 and TNF-α are measured. The values in the following Outcome Measure Data Table refer to the means of measurements at 4 follow-ups.
Outcome measures
| Measure |
Fish Oil Supplementation
n=34 Participants
This group receive 2.5 g/day (two 1.25-g capsules daily) of fish oil (marine-derived n-3 PUFA) for 4 consecutive months.
Fish oil supplementation: Participants of this randomized double-blind placebo-controlled trial include 70 healthy Chinese adults. The investigators randomly assign participants to two parallel groups at baseline using a random-number table. Compliance is determined by directly observed supplement intake. Participants in fish oil group are assigned to receive 2.5 g/day in divided doses. Each capsule contains 60% n-3 PUFA \[24% docosahexanoic acid (C22:6 n-3 DHA) and 36% eicosapentaenoic acid (C20:5 n-3 EPA)\].
|
Sunflower Seed Oil Supplementation
n=31 Participants
This group receive 2.5 g/day (two 1.25-g capsules daily) of placebo (sunflower seed oil) for 4 consecutive months.
Sunflower seed oil supplementation: Participants of this randomized double-blind placebo-controlled trial include 70 healthy Chinese adults. The investigators randomly assign participants to two parallel groups at baseline using a random-number table. Compliance is determined by directly observed supplement intake. Participants in sunflower seed oil group receive 2.5 g/day in divided doses, and the capsules are identical as the fish oil capsules. Each capsule containes 14.4% palmitic acid (C16:0), 16.0% oleic acid (C18:1 n-9), and 57.6% linoleic acid (C18:2 n-6).
|
|---|---|---|
|
Biomarkers of Inflammation-Interleukin-6 (IL-6) and Tumour Necrosis Factor-α (TNF-α)
IL-6
|
0.72 pg/ml
Standard Deviation 0.63
|
1.76 pg/ml
Standard Deviation 5.75
|
|
Biomarkers of Inflammation-Interleukin-6 (IL-6) and Tumour Necrosis Factor-α (TNF-α)
TNF-α
|
0.35 pg/ml
Standard Deviation 0.47
|
0.54 pg/ml
Standard Deviation 1.42
|
PRIMARY outcome
Timeframe: Blood samples are obtained at the end of each round of 4 follow-ups with an interval of 2 weeks in the last 2 months of intervention.We measure vWF level in serum, one of the measured cogulation biomarkers in our study. The values in the following Outcome Measure Data Table refer to the means of measurements at 4 follow-ups.
Outcome measures
| Measure |
Fish Oil Supplementation
n=34 Participants
This group receive 2.5 g/day (two 1.25-g capsules daily) of fish oil (marine-derived n-3 PUFA) for 4 consecutive months.
Fish oil supplementation: Participants of this randomized double-blind placebo-controlled trial include 70 healthy Chinese adults. The investigators randomly assign participants to two parallel groups at baseline using a random-number table. Compliance is determined by directly observed supplement intake. Participants in fish oil group are assigned to receive 2.5 g/day in divided doses. Each capsule contains 60% n-3 PUFA \[24% docosahexanoic acid (C22:6 n-3 DHA) and 36% eicosapentaenoic acid (C20:5 n-3 EPA)\].
|
Sunflower Seed Oil Supplementation
n=31 Participants
This group receive 2.5 g/day (two 1.25-g capsules daily) of placebo (sunflower seed oil) for 4 consecutive months.
Sunflower seed oil supplementation: Participants of this randomized double-blind placebo-controlled trial include 70 healthy Chinese adults. The investigators randomly assign participants to two parallel groups at baseline using a random-number table. Compliance is determined by directly observed supplement intake. Participants in sunflower seed oil group receive 2.5 g/day in divided doses, and the capsules are identical as the fish oil capsules. Each capsule containes 14.4% palmitic acid (C16:0), 16.0% oleic acid (C18:1 n-9), and 57.6% linoleic acid (C18:2 n-6).
|
|---|---|---|
|
Cogulation Biomarker-von Willebrand Factor (vWF)
|
1669.70 mIU/ml
Standard Deviation 1022.98
|
2144.30 mIU/ml
Standard Deviation 1674.32
|
PRIMARY outcome
Timeframe: Blood samples are obtained at the end of each round of 4 follow-ups with an interval of 2 weeks in the last 2 months of intervention.We measure endothelial function biomarkers, including E-selectin and endothelial nitric oxide synthase (eNOS), and 4 stress hormones, including corticotropin releasing hormone (CRH), adrenocorticotropic hormone (ACTH), cortisol and serotonin. The values in the following Outcome Measure Data Table refer to the means of measurements at 4 follow-ups.
Outcome measures
| Measure |
Fish Oil Supplementation
n=34 Participants
This group receive 2.5 g/day (two 1.25-g capsules daily) of fish oil (marine-derived n-3 PUFA) for 4 consecutive months.
Fish oil supplementation: Participants of this randomized double-blind placebo-controlled trial include 70 healthy Chinese adults. The investigators randomly assign participants to two parallel groups at baseline using a random-number table. Compliance is determined by directly observed supplement intake. Participants in fish oil group are assigned to receive 2.5 g/day in divided doses. Each capsule contains 60% n-3 PUFA \[24% docosahexanoic acid (C22:6 n-3 DHA) and 36% eicosapentaenoic acid (C20:5 n-3 EPA)\].
|
Sunflower Seed Oil Supplementation
n=31 Participants
This group receive 2.5 g/day (two 1.25-g capsules daily) of placebo (sunflower seed oil) for 4 consecutive months.
Sunflower seed oil supplementation: Participants of this randomized double-blind placebo-controlled trial include 70 healthy Chinese adults. The investigators randomly assign participants to two parallel groups at baseline using a random-number table. Compliance is determined by directly observed supplement intake. Participants in sunflower seed oil group receive 2.5 g/day in divided doses, and the capsules are identical as the fish oil capsules. Each capsule containes 14.4% palmitic acid (C16:0), 16.0% oleic acid (C18:1 n-9), and 57.6% linoleic acid (C18:2 n-6).
|
|---|---|---|
|
Biomarkers of Endothelial Function and Stress Hormone
serotonin
|
153.56 ng/ml
Standard Deviation 63.89
|
151.17 ng/ml
Standard Deviation 61.63
|
|
Biomarkers of Endothelial Function and Stress Hormone
eNOS
|
5.99 ng/ml
Standard Deviation 9.19
|
4.29 ng/ml
Standard Deviation 7.55
|
|
Biomarkers of Endothelial Function and Stress Hormone
CRH
|
2.96 ng/ml
Standard Deviation 0.48
|
3.06 ng/ml
Standard Deviation 0.47
|
|
Biomarkers of Endothelial Function and Stress Hormone
Cortisol
|
168.01 ng/ml
Standard Deviation 48.62
|
184.49 ng/ml
Standard Deviation 68.42
|
|
Biomarkers of Endothelial Function and Stress Hormone
ACTH
|
0.34 ng/ml
Standard Deviation 0.10
|
0.39 ng/ml
Standard Deviation 0.12
|
|
Biomarkers of Endothelial Function and Stress Hormone
E-selectin
|
12.23 ng/ml
Standard Deviation 5.38
|
14.16 ng/ml
Standard Deviation 6.81
|
PRIMARY outcome
Timeframe: Blood samples are obtained at the end of each round of 4 follow-ups with an interval of 2 weeks in the last 2 months of intervention.We measure ET-1 level in serum, an endothelial function biomarker. The values in the following Outcome Measure Data Table refer to the means of measurements at 4 follow-ups.
Outcome measures
| Measure |
Fish Oil Supplementation
n=34 Participants
This group receive 2.5 g/day (two 1.25-g capsules daily) of fish oil (marine-derived n-3 PUFA) for 4 consecutive months.
Fish oil supplementation: Participants of this randomized double-blind placebo-controlled trial include 70 healthy Chinese adults. The investigators randomly assign participants to two parallel groups at baseline using a random-number table. Compliance is determined by directly observed supplement intake. Participants in fish oil group are assigned to receive 2.5 g/day in divided doses. Each capsule contains 60% n-3 PUFA \[24% docosahexanoic acid (C22:6 n-3 DHA) and 36% eicosapentaenoic acid (C20:5 n-3 EPA)\].
|
Sunflower Seed Oil Supplementation
n=31 Participants
This group receive 2.5 g/day (two 1.25-g capsules daily) of placebo (sunflower seed oil) for 4 consecutive months.
Sunflower seed oil supplementation: Participants of this randomized double-blind placebo-controlled trial include 70 healthy Chinese adults. The investigators randomly assign participants to two parallel groups at baseline using a random-number table. Compliance is determined by directly observed supplement intake. Participants in sunflower seed oil group receive 2.5 g/day in divided doses, and the capsules are identical as the fish oil capsules. Each capsule containes 14.4% palmitic acid (C16:0), 16.0% oleic acid (C18:1 n-9), and 57.6% linoleic acid (C18:2 n-6).
|
|---|---|---|
|
Endothelial Function Biomarker-Endothelin-1(ET-1)
|
1.80 pg/ml
Standard Deviation 2.26
|
2.82 pg/ml
Standard Deviation 4.92
|
PRIMARY outcome
Timeframe: Blood samples are obtained at the end of each round of 4 follow-ups with an interval of 2 weeks in the last 2 months of intervention.We measure the serum level of fibrinogen, one of the two measured cogulation biomarkers in our study. The values in the following Outcome Measure Data Table refer to the means of measurements at 4 follow-ups.
Outcome measures
| Measure |
Fish Oil Supplementation
n=34 Participants
This group receive 2.5 g/day (two 1.25-g capsules daily) of fish oil (marine-derived n-3 PUFA) for 4 consecutive months.
Fish oil supplementation: Participants of this randomized double-blind placebo-controlled trial include 70 healthy Chinese adults. The investigators randomly assign participants to two parallel groups at baseline using a random-number table. Compliance is determined by directly observed supplement intake. Participants in fish oil group are assigned to receive 2.5 g/day in divided doses. Each capsule contains 60% n-3 PUFA \[24% docosahexanoic acid (C22:6 n-3 DHA) and 36% eicosapentaenoic acid (C20:5 n-3 EPA)\].
|
Sunflower Seed Oil Supplementation
n=31 Participants
This group receive 2.5 g/day (two 1.25-g capsules daily) of placebo (sunflower seed oil) for 4 consecutive months.
Sunflower seed oil supplementation: Participants of this randomized double-blind placebo-controlled trial include 70 healthy Chinese adults. The investigators randomly assign participants to two parallel groups at baseline using a random-number table. Compliance is determined by directly observed supplement intake. Participants in sunflower seed oil group receive 2.5 g/day in divided doses, and the capsules are identical as the fish oil capsules. Each capsule containes 14.4% palmitic acid (C16:0), 16.0% oleic acid (C18:1 n-9), and 57.6% linoleic acid (C18:2 n-6).
|
|---|---|---|
|
Cogulation Biomarker-Fibrinogen
|
2.25 µg/ml
Standard Deviation 1.06
|
2.63 µg/ml
Standard Deviation 1.28
|
PRIMARY outcome
Timeframe: Blood samples are obtained at the end of each round of 4 follow-ups with an interval of 2 weeks in the last 2 months of intervention.The serum levels of hs-CRP are measured. The values in the following Outcome Measure Data Table refer to the means of measurements at 4 follow-ups.
Outcome measures
| Measure |
Fish Oil Supplementation
n=34 Participants
This group receive 2.5 g/day (two 1.25-g capsules daily) of fish oil (marine-derived n-3 PUFA) for 4 consecutive months.
Fish oil supplementation: Participants of this randomized double-blind placebo-controlled trial include 70 healthy Chinese adults. The investigators randomly assign participants to two parallel groups at baseline using a random-number table. Compliance is determined by directly observed supplement intake. Participants in fish oil group are assigned to receive 2.5 g/day in divided doses. Each capsule contains 60% n-3 PUFA \[24% docosahexanoic acid (C22:6 n-3 DHA) and 36% eicosapentaenoic acid (C20:5 n-3 EPA)\].
|
Sunflower Seed Oil Supplementation
n=31 Participants
This group receive 2.5 g/day (two 1.25-g capsules daily) of placebo (sunflower seed oil) for 4 consecutive months.
Sunflower seed oil supplementation: Participants of this randomized double-blind placebo-controlled trial include 70 healthy Chinese adults. The investigators randomly assign participants to two parallel groups at baseline using a random-number table. Compliance is determined by directly observed supplement intake. Participants in sunflower seed oil group receive 2.5 g/day in divided doses, and the capsules are identical as the fish oil capsules. Each capsule containes 14.4% palmitic acid (C16:0), 16.0% oleic acid (C18:1 n-9), and 57.6% linoleic acid (C18:2 n-6).
|
|---|---|---|
|
High-sensitivity C-reactive Protein (Hs-CRP)-an Inflammatory Biomarker
|
12.81 µg/ml
Standard Deviation 19.91
|
19.93 µg/ml
Standard Deviation 30.03
|
PRIMARY outcome
Timeframe: Blood samples are obtained at the end of each round of 4 follow-ups with an interval of 2 weeks in the last 2 months of intervention.Peripheral blood samples (5 ml) were drawn, separated into serum, and stored at -80 ℃ within 30 minutes. We measure the serum level of ox-LDL. The values in the following Outcome Measure Data Table refer to the means of measurements at 4 follow-ups.
Outcome measures
| Measure |
Fish Oil Supplementation
n=34 Participants
This group receive 2.5 g/day (two 1.25-g capsules daily) of fish oil (marine-derived n-3 PUFA) for 4 consecutive months.
Fish oil supplementation: Participants of this randomized double-blind placebo-controlled trial include 70 healthy Chinese adults. The investigators randomly assign participants to two parallel groups at baseline using a random-number table. Compliance is determined by directly observed supplement intake. Participants in fish oil group are assigned to receive 2.5 g/day in divided doses. Each capsule contains 60% n-3 PUFA \[24% docosahexanoic acid (C22:6 n-3 DHA) and 36% eicosapentaenoic acid (C20:5 n-3 EPA)\].
|
Sunflower Seed Oil Supplementation
n=31 Participants
This group receive 2.5 g/day (two 1.25-g capsules daily) of placebo (sunflower seed oil) for 4 consecutive months.
Sunflower seed oil supplementation: Participants of this randomized double-blind placebo-controlled trial include 70 healthy Chinese adults. The investigators randomly assign participants to two parallel groups at baseline using a random-number table. Compliance is determined by directly observed supplement intake. Participants in sunflower seed oil group receive 2.5 g/day in divided doses, and the capsules are identical as the fish oil capsules. Each capsule containes 14.4% palmitic acid (C16:0), 16.0% oleic acid (C18:1 n-9), and 57.6% linoleic acid (C18:2 n-6).
|
|---|---|---|
|
Oxidized Low Density Lipoprotein (Ox-LDL)-an Oxidative Stress Biomarker
|
34.74 U/L
Standard Deviation 9.85
|
40.11 U/L
Standard Deviation 22.83
|
PRIMARY outcome
Timeframe: Blood samples are obtained at the end of each round of 4 follow-ups with an interval of 2 weeks in the last 2 months of intervention.Peripheral blood samples (5 ml) were drawn, separated into serum, and stored at -80 ℃ within 30 minutes. We also measure GSH-Px. The values in the following Outcome Measure Data Table refer to the means of measurements at 4 follow-ups.
Outcome measures
| Measure |
Fish Oil Supplementation
n=34 Participants
This group receive 2.5 g/day (two 1.25-g capsules daily) of fish oil (marine-derived n-3 PUFA) for 4 consecutive months.
Fish oil supplementation: Participants of this randomized double-blind placebo-controlled trial include 70 healthy Chinese adults. The investigators randomly assign participants to two parallel groups at baseline using a random-number table. Compliance is determined by directly observed supplement intake. Participants in fish oil group are assigned to receive 2.5 g/day in divided doses. Each capsule contains 60% n-3 PUFA \[24% docosahexanoic acid (C22:6 n-3 DHA) and 36% eicosapentaenoic acid (C20:5 n-3 EPA)\].
|
Sunflower Seed Oil Supplementation
n=31 Participants
This group receive 2.5 g/day (two 1.25-g capsules daily) of placebo (sunflower seed oil) for 4 consecutive months.
Sunflower seed oil supplementation: Participants of this randomized double-blind placebo-controlled trial include 70 healthy Chinese adults. The investigators randomly assign participants to two parallel groups at baseline using a random-number table. Compliance is determined by directly observed supplement intake. Participants in sunflower seed oil group receive 2.5 g/day in divided doses, and the capsules are identical as the fish oil capsules. Each capsule containes 14.4% palmitic acid (C16:0), 16.0% oleic acid (C18:1 n-9), and 57.6% linoleic acid (C18:2 n-6).
|
|---|---|---|
|
Glutathione Peroxidase (GSH-Px)-a Biomarker of Antioxidant Activity
|
625.95 mU/ml
Standard Deviation 157.42
|
581.51 mU/ml
Standard Deviation 171.92
|
PRIMARY outcome
Timeframe: Blood samples are obtained at the end of each round of 4 follow-ups with an interval of 2 weeks in the last 2 months of intervention.Peripheral blood samples (5 ml) were drawn, separated into serum, and stored at -80 ℃ within 30 minutes. We measure the serum level of LPO. The values in the following Outcome Measure Data Table refer to the means of measurements at 4 follow-ups.
Outcome measures
| Measure |
Fish Oil Supplementation
n=34 Participants
This group receive 2.5 g/day (two 1.25-g capsules daily) of fish oil (marine-derived n-3 PUFA) for 4 consecutive months.
Fish oil supplementation: Participants of this randomized double-blind placebo-controlled trial include 70 healthy Chinese adults. The investigators randomly assign participants to two parallel groups at baseline using a random-number table. Compliance is determined by directly observed supplement intake. Participants in fish oil group are assigned to receive 2.5 g/day in divided doses. Each capsule contains 60% n-3 PUFA \[24% docosahexanoic acid (C22:6 n-3 DHA) and 36% eicosapentaenoic acid (C20:5 n-3 EPA)\].
|
Sunflower Seed Oil Supplementation
n=31 Participants
This group receive 2.5 g/day (two 1.25-g capsules daily) of placebo (sunflower seed oil) for 4 consecutive months.
Sunflower seed oil supplementation: Participants of this randomized double-blind placebo-controlled trial include 70 healthy Chinese adults. The investigators randomly assign participants to two parallel groups at baseline using a random-number table. Compliance is determined by directly observed supplement intake. Participants in sunflower seed oil group receive 2.5 g/day in divided doses, and the capsules are identical as the fish oil capsules. Each capsule containes 14.4% palmitic acid (C16:0), 16.0% oleic acid (C18:1 n-9), and 57.6% linoleic acid (C18:2 n-6).
|
|---|---|---|
|
Serum Level of Lipid Peroxidation (LPO)-a Biomarker of Oxdative Stress
|
0.54 µg/ml
Standard Deviation 0.15
|
0.58 µg/ml
Standard Deviation 0.17
|
SECONDARY outcome
Timeframe: Blood pressure are measured at the end of each round of 4 follow-ups with an interval of 2 weeks in the last 2 months of intervention.After sitting in a quiet room for at least 5 min, participants had their left upper arm blood pressure measured by trained technicians using an electronic sphygmomanometer at least three times with 3-min minimum intervals between measurements. The second and third sets of readings were averaged to obtain systolic BP (SBP) and diastolic BP (DBP). If the differences among the three measurements were bigger than 5 mmHg, a new round of measurements was arranged. The values in the following Outcome Measure Data Table refer to the means of measurements at 4 follow-ups.
Outcome measures
| Measure |
Fish Oil Supplementation
n=34 Participants
This group receive 2.5 g/day (two 1.25-g capsules daily) of fish oil (marine-derived n-3 PUFA) for 4 consecutive months.
Fish oil supplementation: Participants of this randomized double-blind placebo-controlled trial include 70 healthy Chinese adults. The investigators randomly assign participants to two parallel groups at baseline using a random-number table. Compliance is determined by directly observed supplement intake. Participants in fish oil group are assigned to receive 2.5 g/day in divided doses. Each capsule contains 60% n-3 PUFA \[24% docosahexanoic acid (C22:6 n-3 DHA) and 36% eicosapentaenoic acid (C20:5 n-3 EPA)\].
|
Sunflower Seed Oil Supplementation
n=31 Participants
This group receive 2.5 g/day (two 1.25-g capsules daily) of placebo (sunflower seed oil) for 4 consecutive months.
Sunflower seed oil supplementation: Participants of this randomized double-blind placebo-controlled trial include 70 healthy Chinese adults. The investigators randomly assign participants to two parallel groups at baseline using a random-number table. Compliance is determined by directly observed supplement intake. Participants in sunflower seed oil group receive 2.5 g/day in divided doses, and the capsules are identical as the fish oil capsules. Each capsule containes 14.4% palmitic acid (C16:0), 16.0% oleic acid (C18:1 n-9), and 57.6% linoleic acid (C18:2 n-6).
|
|---|---|---|
|
Blood Pressure
SBP
|
110.01 mmHg
Standard Deviation 11.39
|
111.55 mmHg
Standard Deviation 10.89
|
|
Blood Pressure
DBP
|
67.20 mmHg
Standard Deviation 6.05
|
67.29 mmHg
Standard Deviation 7.97
|
SECONDARY outcome
Timeframe: Blood samples are obtained at the end of each round of 4 follow-ups with an interval of 2 weeks in the last 2 months of intervention.The biomarker of insulin resistance is measured, calculated by fasting glucose and fasting insulin using the formula of \[fasting insulin (mU/L) × fasting glucose (mmol/L)\]/22.5. The values in the following Outcome Measure Data Table refer to the means of measurements at 4 follow-ups.
Outcome measures
| Measure |
Fish Oil Supplementation
n=34 Participants
This group receive 2.5 g/day (two 1.25-g capsules daily) of fish oil (marine-derived n-3 PUFA) for 4 consecutive months.
Fish oil supplementation: Participants of this randomized double-blind placebo-controlled trial include 70 healthy Chinese adults. The investigators randomly assign participants to two parallel groups at baseline using a random-number table. Compliance is determined by directly observed supplement intake. Participants in fish oil group are assigned to receive 2.5 g/day in divided doses. Each capsule contains 60% n-3 PUFA \[24% docosahexanoic acid (C22:6 n-3 DHA) and 36% eicosapentaenoic acid (C20:5 n-3 EPA)\].
|
Sunflower Seed Oil Supplementation
n=31 Participants
This group receive 2.5 g/day (two 1.25-g capsules daily) of placebo (sunflower seed oil) for 4 consecutive months.
Sunflower seed oil supplementation: Participants of this randomized double-blind placebo-controlled trial include 70 healthy Chinese adults. The investigators randomly assign participants to two parallel groups at baseline using a random-number table. Compliance is determined by directly observed supplement intake. Participants in sunflower seed oil group receive 2.5 g/day in divided doses, and the capsules are identical as the fish oil capsules. Each capsule containes 14.4% palmitic acid (C16:0), 16.0% oleic acid (C18:1 n-9), and 57.6% linoleic acid (C18:2 n-6).
|
|---|---|---|
|
Insulin Resistance
|
1.40 mmol/L × mU/L
Standard Deviation 0.94
|
1.42 mmol/L × mU/L
Standard Deviation 0.91
|
SECONDARY outcome
Timeframe: Skin samplings are obtained at the end of each round of 4 follow-ups with an interval of 2 weeks in the last 2 months of intervention.2 infammation biomarkers from skin samplings are measured, including interleukin-1 Alpha (IL-1α) and Interleukin-1 receptor antagonist (IL-1Rα). The values in the following Outcome Measure Data Table refer to the means of measurements at 4 follow-ups.
Outcome measures
| Measure |
Fish Oil Supplementation
n=34 Participants
This group receive 2.5 g/day (two 1.25-g capsules daily) of fish oil (marine-derived n-3 PUFA) for 4 consecutive months.
Fish oil supplementation: Participants of this randomized double-blind placebo-controlled trial include 70 healthy Chinese adults. The investigators randomly assign participants to two parallel groups at baseline using a random-number table. Compliance is determined by directly observed supplement intake. Participants in fish oil group are assigned to receive 2.5 g/day in divided doses. Each capsule contains 60% n-3 PUFA \[24% docosahexanoic acid (C22:6 n-3 DHA) and 36% eicosapentaenoic acid (C20:5 n-3 EPA)\].
|
Sunflower Seed Oil Supplementation
n=31 Participants
This group receive 2.5 g/day (two 1.25-g capsules daily) of placebo (sunflower seed oil) for 4 consecutive months.
Sunflower seed oil supplementation: Participants of this randomized double-blind placebo-controlled trial include 70 healthy Chinese adults. The investigators randomly assign participants to two parallel groups at baseline using a random-number table. Compliance is determined by directly observed supplement intake. Participants in sunflower seed oil group receive 2.5 g/day in divided doses, and the capsules are identical as the fish oil capsules. Each capsule containes 14.4% palmitic acid (C16:0), 16.0% oleic acid (C18:1 n-9), and 57.6% linoleic acid (C18:2 n-6).
|
|---|---|---|
|
Skin Inflammation Biomarkers
IL-1α
|
184.49 pg/ml
Standard Deviation 107.31
|
230.90 pg/ml
Standard Deviation 163.97
|
|
Skin Inflammation Biomarkers
IL-1Rα
|
54.00 pg/ml
Standard Deviation 93.48
|
42.00 pg/ml
Standard Deviation 119.54
|
SECONDARY outcome
Timeframe: Skin samplings are obtained at the end of each round of 4 follow-ups with an interval of 2 weeks in the last 2 months.oxidative stress biomarker in skin samplings includes carbonyl protein. The values in the following Outcome Measure Data Table refer to the means of measurements at 4 follow-ups.
Outcome measures
| Measure |
Fish Oil Supplementation
n=34 Participants
This group receive 2.5 g/day (two 1.25-g capsules daily) of fish oil (marine-derived n-3 PUFA) for 4 consecutive months.
Fish oil supplementation: Participants of this randomized double-blind placebo-controlled trial include 70 healthy Chinese adults. The investigators randomly assign participants to two parallel groups at baseline using a random-number table. Compliance is determined by directly observed supplement intake. Participants in fish oil group are assigned to receive 2.5 g/day in divided doses. Each capsule contains 60% n-3 PUFA \[24% docosahexanoic acid (C22:6 n-3 DHA) and 36% eicosapentaenoic acid (C20:5 n-3 EPA)\].
|
Sunflower Seed Oil Supplementation
n=31 Participants
This group receive 2.5 g/day (two 1.25-g capsules daily) of placebo (sunflower seed oil) for 4 consecutive months.
Sunflower seed oil supplementation: Participants of this randomized double-blind placebo-controlled trial include 70 healthy Chinese adults. The investigators randomly assign participants to two parallel groups at baseline using a random-number table. Compliance is determined by directly observed supplement intake. Participants in sunflower seed oil group receive 2.5 g/day in divided doses, and the capsules are identical as the fish oil capsules. Each capsule containes 14.4% palmitic acid (C16:0), 16.0% oleic acid (C18:1 n-9), and 57.6% linoleic acid (C18:2 n-6).
|
|---|---|---|
|
Skin Oxidative Stress Biomarker-Carbonyl Protein
|
35.93 µg/ml
Standard Deviation 15.37
|
44.89 µg/ml
Standard Deviation 24.01
|
SECONDARY outcome
Timeframe: Lung function is measured at the end of each round of 4 follow-ups with an interval of 2 weeks in the last 2 months of intervention.Indicators of lung function include forced vital capacity (FVC) and andforced expiratory volume in 1 second (FEV1). The values in the Outcome Measure Data Table refer to the means of measurements at 4 follow-ups.
Outcome measures
| Measure |
Fish Oil Supplementation
n=34 Participants
This group receive 2.5 g/day (two 1.25-g capsules daily) of fish oil (marine-derived n-3 PUFA) for 4 consecutive months.
Fish oil supplementation: Participants of this randomized double-blind placebo-controlled trial include 70 healthy Chinese adults. The investigators randomly assign participants to two parallel groups at baseline using a random-number table. Compliance is determined by directly observed supplement intake. Participants in fish oil group are assigned to receive 2.5 g/day in divided doses. Each capsule contains 60% n-3 PUFA \[24% docosahexanoic acid (C22:6 n-3 DHA) and 36% eicosapentaenoic acid (C20:5 n-3 EPA)\].
|
Sunflower Seed Oil Supplementation
n=31 Participants
This group receive 2.5 g/day (two 1.25-g capsules daily) of placebo (sunflower seed oil) for 4 consecutive months.
Sunflower seed oil supplementation: Participants of this randomized double-blind placebo-controlled trial include 70 healthy Chinese adults. The investigators randomly assign participants to two parallel groups at baseline using a random-number table. Compliance is determined by directly observed supplement intake. Participants in sunflower seed oil group receive 2.5 g/day in divided doses, and the capsules are identical as the fish oil capsules. Each capsule containes 14.4% palmitic acid (C16:0), 16.0% oleic acid (C18:1 n-9), and 57.6% linoleic acid (C18:2 n-6).
|
|---|---|---|
|
Lung Function-Forced Vital Capacity (FVC) and Forced Expiratory Volume in 1 Second (FEV1)
FVC
|
3.18 L
Standard Deviation 0.48
|
3.16 L
Standard Deviation 0.62
|
|
Lung Function-Forced Vital Capacity (FVC) and Forced Expiratory Volume in 1 Second (FEV1)
FEV1
|
3.75 L
Standard Deviation 0.64
|
3.73 L
Standard Deviation 0.87
|
SECONDARY outcome
Timeframe: Lung function is measured at the end of each round of 4 follow-ups with an interval of 2 weeks in the last 2 months of intervention.Additional indicator of lung function includes peak expiratory flow (PEF). The values in the Outcome Measure Data Table refer to the means of measurements at 4 follow-ups.
Outcome measures
| Measure |
Fish Oil Supplementation
n=34 Participants
This group receive 2.5 g/day (two 1.25-g capsules daily) of fish oil (marine-derived n-3 PUFA) for 4 consecutive months.
Fish oil supplementation: Participants of this randomized double-blind placebo-controlled trial include 70 healthy Chinese adults. The investigators randomly assign participants to two parallel groups at baseline using a random-number table. Compliance is determined by directly observed supplement intake. Participants in fish oil group are assigned to receive 2.5 g/day in divided doses. Each capsule contains 60% n-3 PUFA \[24% docosahexanoic acid (C22:6 n-3 DHA) and 36% eicosapentaenoic acid (C20:5 n-3 EPA)\].
|
Sunflower Seed Oil Supplementation
n=31 Participants
This group receive 2.5 g/day (two 1.25-g capsules daily) of placebo (sunflower seed oil) for 4 consecutive months.
Sunflower seed oil supplementation: Participants of this randomized double-blind placebo-controlled trial include 70 healthy Chinese adults. The investigators randomly assign participants to two parallel groups at baseline using a random-number table. Compliance is determined by directly observed supplement intake. Participants in sunflower seed oil group receive 2.5 g/day in divided doses, and the capsules are identical as the fish oil capsules. Each capsule containes 14.4% palmitic acid (C16:0), 16.0% oleic acid (C18:1 n-9), and 57.6% linoleic acid (C18:2 n-6).
|
|---|---|---|
|
Lung Function-Peak Expiratory Flow (PEF)
|
6.55 L/s
Standard Deviation 1.44
|
6.38 L/s
Standard Deviation 1.60
|
SECONDARY outcome
Timeframe: Skin samplings are obtained at the end of each round of 4 follow-ups with an interval of 2 weeks in the last 2 months.we measure TAC level, an antioxidant biomarker in skin samplings. The values in the following Outcome Measure Data Table refer to the means of measurements at 4 follow-ups.
Outcome measures
| Measure |
Fish Oil Supplementation
n=34 Participants
This group receive 2.5 g/day (two 1.25-g capsules daily) of fish oil (marine-derived n-3 PUFA) for 4 consecutive months.
Fish oil supplementation: Participants of this randomized double-blind placebo-controlled trial include 70 healthy Chinese adults. The investigators randomly assign participants to two parallel groups at baseline using a random-number table. Compliance is determined by directly observed supplement intake. Participants in fish oil group are assigned to receive 2.5 g/day in divided doses. Each capsule contains 60% n-3 PUFA \[24% docosahexanoic acid (C22:6 n-3 DHA) and 36% eicosapentaenoic acid (C20:5 n-3 EPA)\].
|
Sunflower Seed Oil Supplementation
n=31 Participants
This group receive 2.5 g/day (two 1.25-g capsules daily) of placebo (sunflower seed oil) for 4 consecutive months.
Sunflower seed oil supplementation: Participants of this randomized double-blind placebo-controlled trial include 70 healthy Chinese adults. The investigators randomly assign participants to two parallel groups at baseline using a random-number table. Compliance is determined by directly observed supplement intake. Participants in sunflower seed oil group receive 2.5 g/day in divided doses, and the capsules are identical as the fish oil capsules. Each capsule containes 14.4% palmitic acid (C16:0), 16.0% oleic acid (C18:1 n-9), and 57.6% linoleic acid (C18:2 n-6).
|
|---|---|---|
|
Skin Antioxidant Biomarker-Total Antioxidant Capacity (TAC)
|
42.99 nmol/mL
Standard Deviation 95.34
|
35.73 nmol/mL
Standard Deviation 17.55
|
SECONDARY outcome
Timeframe: Skin samplings are obtained at the end of each round of 4 follow-ups with an interval of 2 weeks in the last 2 months.we measure another skin antioxidant biomarker-GSH, . The values in the following Outcome Measure Data Table refer to the means of measurements at 4 follow-ups.
Outcome measures
| Measure |
Fish Oil Supplementation
n=34 Participants
This group receive 2.5 g/day (two 1.25-g capsules daily) of fish oil (marine-derived n-3 PUFA) for 4 consecutive months.
Fish oil supplementation: Participants of this randomized double-blind placebo-controlled trial include 70 healthy Chinese adults. The investigators randomly assign participants to two parallel groups at baseline using a random-number table. Compliance is determined by directly observed supplement intake. Participants in fish oil group are assigned to receive 2.5 g/day in divided doses. Each capsule contains 60% n-3 PUFA \[24% docosahexanoic acid (C22:6 n-3 DHA) and 36% eicosapentaenoic acid (C20:5 n-3 EPA)\].
|
Sunflower Seed Oil Supplementation
n=31 Participants
This group receive 2.5 g/day (two 1.25-g capsules daily) of placebo (sunflower seed oil) for 4 consecutive months.
Sunflower seed oil supplementation: Participants of this randomized double-blind placebo-controlled trial include 70 healthy Chinese adults. The investigators randomly assign participants to two parallel groups at baseline using a random-number table. Compliance is determined by directly observed supplement intake. Participants in sunflower seed oil group receive 2.5 g/day in divided doses, and the capsules are identical as the fish oil capsules. Each capsule containes 14.4% palmitic acid (C16:0), 16.0% oleic acid (C18:1 n-9), and 57.6% linoleic acid (C18:2 n-6).
|
|---|---|---|
|
Skin Antioxidant Biomarker-Glutataione (GSH)
|
2.21 ppb
Standard Deviation 1.70
|
0.42 ppb
Standard Deviation 1.07
|
POST_HOC outcome
Timeframe: Blood samples are obtained at the end of each round of 4 follow-ups with an interval of 2 weeks in the last 2 months of intervention.Mass spectrometry-based serum metabolomics is non-targeted. The study is to find the differential metabolites in serum between fish oil and placebo groups.
Outcome measures
Outcome data not reported
Adverse Events
Fish Oil Supplementation
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Sunflower Seed Oil Supplementation
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
Dr. Haidong Kan
Department of Environmental Health, School of Public Health, Fudan University
Phone: 86-21-54237908
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place