Trial Outcomes & Findings for Dietary Essential Fatty Acid Regulation of Omega-3 HUFA Metabolism; Satiety and Body Composition (NCT NCT01251887)
NCT ID: NCT01251887
Last Updated: 2021-09-05
Results Overview
Tissue accretion of omega-6 (n-6) highly unsaturated fatty acids (HUFA) in fasting plasma as percent of total HUFA.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
85 participants
Primary outcome timeframe
Baseline
Results posted on
2021-09-05
Participant Flow
85 subjects were consented to protocol. 19 of the 85 subjects were screen failures and one subject cancelled prior to start of study due to scheduling conflict.
Participant milestones
| Measure |
Diet A: Low Omega-3 (n-3) + High Linoleic Acid (LA)
Study diet containing 8 % energy (en%) linoleic acid (LA), 0.4 % energy (en%) arachidonic acid (AA), 0.05 % omega-3 highly unsaturated fatty acids (HUFA) for 12 weeks
|
Diet B: Low Omega-3 (n-3) + Low Linoleic Acid (LA)
Study diet containing 1 % energy (en%) linoleic acid (LA), 0.4 % energy (en%) arachidonic acid (AA), 0.05 % omega-3 highly unsaturated fatty acids highly unsaturated fatty acids (HUFA) for 12 weeks
|
Diet C: High Omega-3 (n-3) + Low Linoleic Acid (LA)
Study diet containing 1 % energy (en%) linoleic acid (LA), 0.4 % energy (en%) arachidonic acid (AA), 0.81 % omega-3 (n-3) HUFA for 12 weeks
|
|---|---|---|---|
|
Overall Study
STARTED
|
18
|
29
|
18
|
|
Overall Study
COMPLETED
|
17
|
26
|
16
|
|
Overall Study
NOT COMPLETED
|
1
|
3
|
2
|
Reasons for withdrawal
| Measure |
Diet A: Low Omega-3 (n-3) + High Linoleic Acid (LA)
Study diet containing 8 % energy (en%) linoleic acid (LA), 0.4 % energy (en%) arachidonic acid (AA), 0.05 % omega-3 highly unsaturated fatty acids (HUFA) for 12 weeks
|
Diet B: Low Omega-3 (n-3) + Low Linoleic Acid (LA)
Study diet containing 1 % energy (en%) linoleic acid (LA), 0.4 % energy (en%) arachidonic acid (AA), 0.05 % omega-3 highly unsaturated fatty acids highly unsaturated fatty acids (HUFA) for 12 weeks
|
Diet C: High Omega-3 (n-3) + Low Linoleic Acid (LA)
Study diet containing 1 % energy (en%) linoleic acid (LA), 0.4 % energy (en%) arachidonic acid (AA), 0.81 % omega-3 (n-3) HUFA for 12 weeks
|
|---|---|---|---|
|
Overall Study
Scheduling conflict
|
1
|
2
|
2
|
|
Overall Study
Physician Decision
|
0
|
1
|
0
|
Baseline Characteristics
Dietary Essential Fatty Acid Regulation of Omega-3 HUFA Metabolism; Satiety and Body Composition
Baseline characteristics by cohort
| Measure |
Diet A: Low Omega-3 (n-3) + High Linoleic Acid (LA)
n=18 Participants
Study diet containing 8 % energy (en%) linoleic acid (LA), 0.4 % energy (en%) arachidonic acid (AA), 0.05 % omega-3 highly unsaturated fatty acids (HUFA) for 12 weeks
|
Diet B: Low Omega-3 (n-3) + Low Linoleic Acid (LA)
n=29 Participants
Study diet containing 1 % energy (en%) linoleic acid (LA), 0.4 % energy (en%) arachidonic acid (AA), 0.05 % omega-3 highly unsaturated fatty acids highly unsaturated fatty acids (HUFA) for 12 weeks
|
Diet C: High Omega-3 (n-3) + Low Linoleic Acid (LA)
n=18 Participants
Study diet containing 1 % energy (en%) linoleic acid (LA), 0.4 % energy (en%) arachidonic acid (AA), 0.81 % omega-3 (n-3) HUFA for 12 weeks
|
Total
n=65 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
18 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
65 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
65 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
17 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
56 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 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
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
8 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
27 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
25 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: BaselinePopulation: The analyses included only those participants who completed at least 4 weeks of the diet phase with fasting blood samples available
Tissue accretion of omega-6 (n-6) highly unsaturated fatty acids (HUFA) in fasting plasma as percent of total HUFA.
Outcome measures
| Measure |
Diet A: Low Omega-3 (n-3) + High Linoleic Acid (LA)
n=16 Participants
Study diet containing 8 % energy (en%) linoleic acid (LA), 0.4 % energy (en%) arachidonic acid (AA), 0.05 % omega-3 highly unsaturated fatty acids (HUFA) for 12 weeks
|
Diet B: Low Omega-3 (n-3) + Low Linoleic Acid (LA)
n=28 Participants
Study diet containing 1 % energy (en%) linoleic acid (LA), 0.4 % energy (en%) arachidonic acid (AA), 0.05 % omega-3 highly unsaturated fatty acids highly unsaturated fatty acids (HUFA) for 12 weeks
|
Diet C: High Omega-3 (n-3) + Low Linoleic Acid (LA)
n=17 Participants
Study diet containing 1 % energy (en%) linoleic acid (LA), 0.4 % energy (en%) arachidonic acid (AA), 0.81 % omega-3 (n-3) HUFA for 12 weeks
|
|---|---|---|---|
|
Proportion of n-6 HUFA in Total HUFA (%n-6 in HUFA)
|
80.0 Percentage of total HUFA
Standard Error 1.2
|
81.3 Percentage of total HUFA
Standard Error 0.9
|
80.5 Percentage of total HUFA
Standard Error 1.1
|
PRIMARY outcome
Timeframe: Week 4Population: The analyses included only those participants who completed at least 4 weeks of the diet phase with fasting blood samples available
Tissue accretion of omega-6 (n-6) highly unsaturated fatty acids (HUFA) in fasting plasma as percent of total HUFA.
Outcome measures
| Measure |
Diet A: Low Omega-3 (n-3) + High Linoleic Acid (LA)
n=16 Participants
Study diet containing 8 % energy (en%) linoleic acid (LA), 0.4 % energy (en%) arachidonic acid (AA), 0.05 % omega-3 highly unsaturated fatty acids (HUFA) for 12 weeks
|
Diet B: Low Omega-3 (n-3) + Low Linoleic Acid (LA)
n=28 Participants
Study diet containing 1 % energy (en%) linoleic acid (LA), 0.4 % energy (en%) arachidonic acid (AA), 0.05 % omega-3 highly unsaturated fatty acids highly unsaturated fatty acids (HUFA) for 12 weeks
|
Diet C: High Omega-3 (n-3) + Low Linoleic Acid (LA)
n=17 Participants
Study diet containing 1 % energy (en%) linoleic acid (LA), 0.4 % energy (en%) arachidonic acid (AA), 0.81 % omega-3 (n-3) HUFA for 12 weeks
|
|---|---|---|---|
|
Proportion of n-6 HUFA in Total HUFA (%n-6 in HUFA)
|
80 Percentage of total HUFA
Standard Error 1.1
|
80.7 Percentage of total HUFA
Standard Error 0.9
|
70.6 Percentage of total HUFA
Standard Error 1.1
|
PRIMARY outcome
Timeframe: Week 8Population: The analyses included only those participants who completed at least 4 weeks of the diet phase with fasting blood samples available
Tissue accretion of omega-6 (n-6) highly unsaturated fatty acids (HUFA) in fasting plasma as percent of total HUFA.
Outcome measures
| Measure |
Diet A: Low Omega-3 (n-3) + High Linoleic Acid (LA)
n=16 Participants
Study diet containing 8 % energy (en%) linoleic acid (LA), 0.4 % energy (en%) arachidonic acid (AA), 0.05 % omega-3 highly unsaturated fatty acids (HUFA) for 12 weeks
|
Diet B: Low Omega-3 (n-3) + Low Linoleic Acid (LA)
n=28 Participants
Study diet containing 1 % energy (en%) linoleic acid (LA), 0.4 % energy (en%) arachidonic acid (AA), 0.05 % omega-3 highly unsaturated fatty acids highly unsaturated fatty acids (HUFA) for 12 weeks
|
Diet C: High Omega-3 (n-3) + Low Linoleic Acid (LA)
n=17 Participants
Study diet containing 1 % energy (en%) linoleic acid (LA), 0.4 % energy (en%) arachidonic acid (AA), 0.81 % omega-3 (n-3) HUFA for 12 weeks
|
|---|---|---|---|
|
Proportion of n-6 HUFA in Total HUFA (%n-6 in HUFA)
|
79.7 Percentage of total HUFA
Standard Error 1.2
|
80.6 Percentage of total HUFA
Standard Error 0.9
|
70.8 Percentage of total HUFA
Standard Error 1.1
|
PRIMARY outcome
Timeframe: Week 12Population: The analyses included only those participants who completed at least 4 weeks of the diet phase with fasting blood samples available
Tissue accretion of omega-6 (n-6) highly unsaturated fatty acids (HUFA) in fasting plasma as percent of total HUFA.
Outcome measures
| Measure |
Diet A: Low Omega-3 (n-3) + High Linoleic Acid (LA)
n=16 Participants
Study diet containing 8 % energy (en%) linoleic acid (LA), 0.4 % energy (en%) arachidonic acid (AA), 0.05 % omega-3 highly unsaturated fatty acids (HUFA) for 12 weeks
|
Diet B: Low Omega-3 (n-3) + Low Linoleic Acid (LA)
n=28 Participants
Study diet containing 1 % energy (en%) linoleic acid (LA), 0.4 % energy (en%) arachidonic acid (AA), 0.05 % omega-3 highly unsaturated fatty acids highly unsaturated fatty acids (HUFA) for 12 weeks
|
Diet C: High Omega-3 (n-3) + Low Linoleic Acid (LA)
n=17 Participants
Study diet containing 1 % energy (en%) linoleic acid (LA), 0.4 % energy (en%) arachidonic acid (AA), 0.81 % omega-3 (n-3) HUFA for 12 weeks
|
|---|---|---|---|
|
Proportion of n-6 HUFA in Total HUFA (%n-6 in HUFA)
|
80.6 Percentage of total HUFA
Standard Error 1.1
|
81 Percentage of total HUFA
Standard Error 0.9
|
72.9 Percentage of total HUFA
Standard Error 1.1
|
SECONDARY outcome
Timeframe: BaselinePopulation: The analyses included only those participants who completed at least 4 weeks of the diet phase with fasting blood samples available
Tissue accretion of Arachidonic Acid (AA or 20:4n6), an omega-6 (n-6) highly unsaturated fatty acid, as measured in fasting plasma as a percent of total fatty acids.
Outcome measures
| Measure |
Diet A: Low Omega-3 (n-3) + High Linoleic Acid (LA)
n=16 Participants
Study diet containing 8 % energy (en%) linoleic acid (LA), 0.4 % energy (en%) arachidonic acid (AA), 0.05 % omega-3 highly unsaturated fatty acids (HUFA) for 12 weeks
|
Diet B: Low Omega-3 (n-3) + Low Linoleic Acid (LA)
n=28 Participants
Study diet containing 1 % energy (en%) linoleic acid (LA), 0.4 % energy (en%) arachidonic acid (AA), 0.05 % omega-3 highly unsaturated fatty acids highly unsaturated fatty acids (HUFA) for 12 weeks
|
Diet C: High Omega-3 (n-3) + Low Linoleic Acid (LA)
n=17 Participants
Study diet containing 1 % energy (en%) linoleic acid (LA), 0.4 % energy (en%) arachidonic acid (AA), 0.81 % omega-3 (n-3) HUFA for 12 weeks
|
|---|---|---|---|
|
Proportion of n-6 HUFA Arachidonic Acid (AA)
|
6.42 Percentage of total fatty acids
Standard Error 0.3
|
6.51 Percentage of total fatty acids
Standard Error 0.22
|
7.12 Percentage of total fatty acids
Standard Error 0.29
|
SECONDARY outcome
Timeframe: Week 4Population: The analyses included only those participants who completed at least 4 weeks of the diet phase with fasting blood samples available
Tissue accretion of Arachidonic Acid (AA or 20:4n6), an omega-6 (n-6) highly unsaturated fatty acid, as measured in fasting plasma as a percent of total fatty acids.
Outcome measures
| Measure |
Diet A: Low Omega-3 (n-3) + High Linoleic Acid (LA)
n=16 Participants
Study diet containing 8 % energy (en%) linoleic acid (LA), 0.4 % energy (en%) arachidonic acid (AA), 0.05 % omega-3 highly unsaturated fatty acids (HUFA) for 12 weeks
|
Diet B: Low Omega-3 (n-3) + Low Linoleic Acid (LA)
n=28 Participants
Study diet containing 1 % energy (en%) linoleic acid (LA), 0.4 % energy (en%) arachidonic acid (AA), 0.05 % omega-3 highly unsaturated fatty acids highly unsaturated fatty acids (HUFA) for 12 weeks
|
Diet C: High Omega-3 (n-3) + Low Linoleic Acid (LA)
n=17 Participants
Study diet containing 1 % energy (en%) linoleic acid (LA), 0.4 % energy (en%) arachidonic acid (AA), 0.81 % omega-3 (n-3) HUFA for 12 weeks
|
|---|---|---|---|
|
Proportion of n-6 HUFA Arachidonic Acid (AA)
|
6.25 Percentage of total fatty acids
Standard Error 0.29
|
7.02 Percentage of total fatty acids
Standard Error 0.22
|
6.37 Percentage of total fatty acids
Standard Error 0.28
|
SECONDARY outcome
Timeframe: Week 8Population: The analyses included only those participants who completed at least 4 weeks of the diet phase with fasting blood samples available
Tissue accretion of Arachidonic Acid (AA or 20:4n6), an omega-6 (n-6) highly unsaturated fatty acid, as measured in fasting plasma as a percent of total fatty acids.
Outcome measures
| Measure |
Diet A: Low Omega-3 (n-3) + High Linoleic Acid (LA)
n=16 Participants
Study diet containing 8 % energy (en%) linoleic acid (LA), 0.4 % energy (en%) arachidonic acid (AA), 0.05 % omega-3 highly unsaturated fatty acids (HUFA) for 12 weeks
|
Diet B: Low Omega-3 (n-3) + Low Linoleic Acid (LA)
n=28 Participants
Study diet containing 1 % energy (en%) linoleic acid (LA), 0.4 % energy (en%) arachidonic acid (AA), 0.05 % omega-3 highly unsaturated fatty acids highly unsaturated fatty acids (HUFA) for 12 weeks
|
Diet C: High Omega-3 (n-3) + Low Linoleic Acid (LA)
n=17 Participants
Study diet containing 1 % energy (en%) linoleic acid (LA), 0.4 % energy (en%) arachidonic acid (AA), 0.81 % omega-3 (n-3) HUFA for 12 weeks
|
|---|---|---|---|
|
Proportion of n-6 HUFA Arachidonic Acid (AA)
|
6.59 Percentage of total fatty acids
Standard Error 0.30
|
7.27 Percentage of total fatty acids
Standard Error 0.23
|
6.40 Percentage of total fatty acids
Standard Error 0.28
|
SECONDARY outcome
Timeframe: Week 12Population: The analyses included only those participants who completed at least 4 weeks of the diet phase with fasting blood samples available
Tissue accretion of Arachidonic Acid (AA or 20:4n6), an omega-6 (n-6) highly unsaturated fatty acid, as measured in fasting plasma as a percent of total fatty acids.
Outcome measures
| Measure |
Diet A: Low Omega-3 (n-3) + High Linoleic Acid (LA)
n=16 Participants
Study diet containing 8 % energy (en%) linoleic acid (LA), 0.4 % energy (en%) arachidonic acid (AA), 0.05 % omega-3 highly unsaturated fatty acids (HUFA) for 12 weeks
|
Diet B: Low Omega-3 (n-3) + Low Linoleic Acid (LA)
n=28 Participants
Study diet containing 1 % energy (en%) linoleic acid (LA), 0.4 % energy (en%) arachidonic acid (AA), 0.05 % omega-3 highly unsaturated fatty acids highly unsaturated fatty acids (HUFA) for 12 weeks
|
Diet C: High Omega-3 (n-3) + Low Linoleic Acid (LA)
n=17 Participants
Study diet containing 1 % energy (en%) linoleic acid (LA), 0.4 % energy (en%) arachidonic acid (AA), 0.81 % omega-3 (n-3) HUFA for 12 weeks
|
|---|---|---|---|
|
Proportion of n-6 HUFA Arachidonic Acid (AA)
|
6.45 Percentage of total fatty acids
Standard Error 0.29
|
7.02 Percentage of total fatty acids
Standard Error 0.22
|
6.21 Percentage of total fatty acids
Standard Error 0.28
|
SECONDARY outcome
Timeframe: BaselinePopulation: The analyses included only those participants who completed at least 4 weeks of the diet phase with fasting blood samples available
Tissue accretion of eicosapentaenoic acid (EPA or 20:5n3), an omega-3 (n-3) highly unsaturated fatty acid (HUFA), as measured in fasting plasma as a percent of total fatty acids.
Outcome measures
| Measure |
Diet A: Low Omega-3 (n-3) + High Linoleic Acid (LA)
n=16 Participants
Study diet containing 8 % energy (en%) linoleic acid (LA), 0.4 % energy (en%) arachidonic acid (AA), 0.05 % omega-3 highly unsaturated fatty acids (HUFA) for 12 weeks
|
Diet B: Low Omega-3 (n-3) + Low Linoleic Acid (LA)
n=28 Participants
Study diet containing 1 % energy (en%) linoleic acid (LA), 0.4 % energy (en%) arachidonic acid (AA), 0.05 % omega-3 highly unsaturated fatty acids highly unsaturated fatty acids (HUFA) for 12 weeks
|
Diet C: High Omega-3 (n-3) + Low Linoleic Acid (LA)
n=17 Participants
Study diet containing 1 % energy (en%) linoleic acid (LA), 0.4 % energy (en%) arachidonic acid (AA), 0.81 % omega-3 (n-3) HUFA for 12 weeks
|
|---|---|---|---|
|
Proportion of n-3 HUFA Eicosapentaenoic Acid (EPA)
|
0.434 Percentage of total fatty acids
Standard Error 0.065
|
0.455 Percentage of total fatty acids
Standard Error 0.046
|
0.504 Percentage of total fatty acids
Standard Error 0.062
|
SECONDARY outcome
Timeframe: Week 4Population: The analyses included only those participants who completed at least 4 weeks of the diet phase with fasting blood samples available
Tissue accretion of eicosapentaenoic acid (EPA or 20:5n3), an omega-3 (n-3) highly unsaturated fatty acid (HUFA), as measured in fasting plasma as a percent of total fatty acids.
Outcome measures
| Measure |
Diet A: Low Omega-3 (n-3) + High Linoleic Acid (LA)
n=16 Participants
Study diet containing 8 % energy (en%) linoleic acid (LA), 0.4 % energy (en%) arachidonic acid (AA), 0.05 % omega-3 highly unsaturated fatty acids (HUFA) for 12 weeks
|
Diet B: Low Omega-3 (n-3) + Low Linoleic Acid (LA)
n=28 Participants
Study diet containing 1 % energy (en%) linoleic acid (LA), 0.4 % energy (en%) arachidonic acid (AA), 0.05 % omega-3 highly unsaturated fatty acids highly unsaturated fatty acids (HUFA) for 12 weeks
|
Diet C: High Omega-3 (n-3) + Low Linoleic Acid (LA)
n=17 Participants
Study diet containing 1 % energy (en%) linoleic acid (LA), 0.4 % energy (en%) arachidonic acid (AA), 0.81 % omega-3 (n-3) HUFA for 12 weeks
|
|---|---|---|---|
|
Proportion of n-3 HUFA Eicosapentaenoic Acid (EPA)
|
0.356 Percentage of total fatty acids
Standard Error 0.061
|
0.479 Percentage of total fatty acids
Standard Error 0.047
|
0.927 Percentage of total fatty acids
Standard Error 0.061
|
SECONDARY outcome
Timeframe: Week 8Population: The analyses included only those participants who completed at least 4 weeks of the diet phase with fasting blood samples available
Tissue accretion of eicosapentaenoic acid (EPA or 20:5n3), an omega-3 (n-3) highly unsaturated fatty acid (HUFA), as measured in fasting plasma as a percent of total fatty acids.
Outcome measures
| Measure |
Diet A: Low Omega-3 (n-3) + High Linoleic Acid (LA)
n=16 Participants
Study diet containing 8 % energy (en%) linoleic acid (LA), 0.4 % energy (en%) arachidonic acid (AA), 0.05 % omega-3 highly unsaturated fatty acids (HUFA) for 12 weeks
|
Diet B: Low Omega-3 (n-3) + Low Linoleic Acid (LA)
n=28 Participants
Study diet containing 1 % energy (en%) linoleic acid (LA), 0.4 % energy (en%) arachidonic acid (AA), 0.05 % omega-3 highly unsaturated fatty acids highly unsaturated fatty acids (HUFA) for 12 weeks
|
Diet C: High Omega-3 (n-3) + Low Linoleic Acid (LA)
n=17 Participants
Study diet containing 1 % energy (en%) linoleic acid (LA), 0.4 % energy (en%) arachidonic acid (AA), 0.81 % omega-3 (n-3) HUFA for 12 weeks
|
|---|---|---|---|
|
Proportion of n-3 HUFA Eicosapentaenoic Acid (EPA)
|
0.324 Percentage of total fatty acids
Standard Error 0.064
|
0.452 Percentage of total fatty acids
Standard Error 0.051
|
0.806 Percentage of total fatty acids
Standard Error 0.061
|
SECONDARY outcome
Timeframe: Week 12Population: The analyses included only those participants who completed at least 4 weeks of the diet phase with fasting blood samples available
Tissue accretion of eicosapentaenoic acid (EPA or 20:5n3), an omega-3 (n-3) highly unsaturated fatty acid (HUFA), as measured in fasting plasma as a percent of total fatty acids.
Outcome measures
| Measure |
Diet A: Low Omega-3 (n-3) + High Linoleic Acid (LA)
n=16 Participants
Study diet containing 8 % energy (en%) linoleic acid (LA), 0.4 % energy (en%) arachidonic acid (AA), 0.05 % omega-3 highly unsaturated fatty acids (HUFA) for 12 weeks
|
Diet B: Low Omega-3 (n-3) + Low Linoleic Acid (LA)
n=28 Participants
Study diet containing 1 % energy (en%) linoleic acid (LA), 0.4 % energy (en%) arachidonic acid (AA), 0.05 % omega-3 highly unsaturated fatty acids highly unsaturated fatty acids (HUFA) for 12 weeks
|
Diet C: High Omega-3 (n-3) + Low Linoleic Acid (LA)
n=17 Participants
Study diet containing 1 % energy (en%) linoleic acid (LA), 0.4 % energy (en%) arachidonic acid (AA), 0.81 % omega-3 (n-3) HUFA for 12 weeks
|
|---|---|---|---|
|
Proportion of n-3 HUFA Eicosapentaenoic Acid (EPA)
|
0.338 Percentage of total fatty acids
Standard Error 0.061
|
0.388 Percentage of total fatty acids
Standard Error 0.048
|
0.707 Percentage of total fatty acids
Standard Error 0.062
|
SECONDARY outcome
Timeframe: BaselinePopulation: The analyses included only those participants who completed at least 4 weeks of the diet phase with fasting blood samples available
Tissue accretion of Docosahexaenoic Acid (DHA or 22:6n3), an omega-3 (n-3) highly unsaturated fatty acid (HUFA), as measured in fasting plasma as a percent of total fatty acids.
Outcome measures
| Measure |
Diet A: Low Omega-3 (n-3) + High Linoleic Acid (LA)
n=16 Participants
Study diet containing 8 % energy (en%) linoleic acid (LA), 0.4 % energy (en%) arachidonic acid (AA), 0.05 % omega-3 highly unsaturated fatty acids (HUFA) for 12 weeks
|
Diet B: Low Omega-3 (n-3) + Low Linoleic Acid (LA)
n=28 Participants
Study diet containing 1 % energy (en%) linoleic acid (LA), 0.4 % energy (en%) arachidonic acid (AA), 0.05 % omega-3 highly unsaturated fatty acids highly unsaturated fatty acids (HUFA) for 12 weeks
|
Diet C: High Omega-3 (n-3) + Low Linoleic Acid (LA)
n=17 Participants
Study diet containing 1 % energy (en%) linoleic acid (LA), 0.4 % energy (en%) arachidonic acid (AA), 0.81 % omega-3 (n-3) HUFA for 12 weeks
|
|---|---|---|---|
|
Proportion of n-3 HUFA Docosahexaenoic Acid (DHA)
|
1.30 Percentage of total fatty acids
Standard Error 0.11
|
1.16 Percentage of total fatty acids
Standard Error 0.08
|
1.41 Percentage of total fatty acids
Standard Error 0.11
|
SECONDARY outcome
Timeframe: Week 4Population: The analyses included only those participants who completed at least 4 weeks of the diet phase with fasting blood samples available
Tissue accretion of Docosahexaenoic Acid (DHA or 22:6n3), an omega-3 (n-3) highly unsaturated fatty acid (HUFA), as measured in fasting plasma as a percent of total fatty acids.
Outcome measures
| Measure |
Diet A: Low Omega-3 (n-3) + High Linoleic Acid (LA)
n=16 Participants
Study diet containing 8 % energy (en%) linoleic acid (LA), 0.4 % energy (en%) arachidonic acid (AA), 0.05 % omega-3 highly unsaturated fatty acids (HUFA) for 12 weeks
|
Diet B: Low Omega-3 (n-3) + Low Linoleic Acid (LA)
n=28 Participants
Study diet containing 1 % energy (en%) linoleic acid (LA), 0.4 % energy (en%) arachidonic acid (AA), 0.05 % omega-3 highly unsaturated fatty acids highly unsaturated fatty acids (HUFA) for 12 weeks
|
Diet C: High Omega-3 (n-3) + Low Linoleic Acid (LA)
n=17 Participants
Study diet containing 1 % energy (en%) linoleic acid (LA), 0.4 % energy (en%) arachidonic acid (AA), 0.81 % omega-3 (n-3) HUFA for 12 weeks
|
|---|---|---|---|
|
Proportion of n-3 HUFA Docosahexaenoic Acid (DHA)
|
1.39 Percentage of total fatty acids
Standard Error 0.11
|
1.38 Percentage of total fatty acids
Standard Error 0.08
|
2.25 Percentage of total fatty acids
Standard Error 0.11
|
SECONDARY outcome
Timeframe: Week 8Population: The analyses included only those participants who completed at least 4 weeks of the diet phase with fasting blood samples available
Tissue accretion of Docosahexaenoic Acid (DHA or 22:6n3), an omega-3 (n-3) highly unsaturated fatty acid (HUFA), as measured in fasting plasma as a percent of total fatty acids.
Outcome measures
| Measure |
Diet A: Low Omega-3 (n-3) + High Linoleic Acid (LA)
n=16 Participants
Study diet containing 8 % energy (en%) linoleic acid (LA), 0.4 % energy (en%) arachidonic acid (AA), 0.05 % omega-3 highly unsaturated fatty acids (HUFA) for 12 weeks
|
Diet B: Low Omega-3 (n-3) + Low Linoleic Acid (LA)
n=28 Participants
Study diet containing 1 % energy (en%) linoleic acid (LA), 0.4 % energy (en%) arachidonic acid (AA), 0.05 % omega-3 highly unsaturated fatty acids highly unsaturated fatty acids (HUFA) for 12 weeks
|
Diet C: High Omega-3 (n-3) + Low Linoleic Acid (LA)
n=17 Participants
Study diet containing 1 % energy (en%) linoleic acid (LA), 0.4 % energy (en%) arachidonic acid (AA), 0.81 % omega-3 (n-3) HUFA for 12 weeks
|
|---|---|---|---|
|
Proportion of n-3 HUFA Docosahexaenoic Acid (DHA)
|
1.48 Percentage of total fatty acids
Standard Error 0.11
|
1.44 Percentage of total fatty acids
Standard Error 0.09
|
2.13 Percentage of total fatty acids
Standard Error 0.11
|
SECONDARY outcome
Timeframe: Week 12Population: The analyses included only those participants who completed at least 4 weeks of the diet phase with fasting blood samples available
Tissue accretion of Docosahexaenoic Acid (DHA or 22:6n3), an omega-3 (n-3) highly unsaturated fatty acid (HUFA), as measured in fasting plasma as a percent of total fatty acids.
Outcome measures
| Measure |
Diet A: Low Omega-3 (n-3) + High Linoleic Acid (LA)
n=16 Participants
Study diet containing 8 % energy (en%) linoleic acid (LA), 0.4 % energy (en%) arachidonic acid (AA), 0.05 % omega-3 highly unsaturated fatty acids (HUFA) for 12 weeks
|
Diet B: Low Omega-3 (n-3) + Low Linoleic Acid (LA)
n=28 Participants
Study diet containing 1 % energy (en%) linoleic acid (LA), 0.4 % energy (en%) arachidonic acid (AA), 0.05 % omega-3 highly unsaturated fatty acids highly unsaturated fatty acids (HUFA) for 12 weeks
|
Diet C: High Omega-3 (n-3) + Low Linoleic Acid (LA)
n=17 Participants
Study diet containing 1 % energy (en%) linoleic acid (LA), 0.4 % energy (en%) arachidonic acid (AA), 0.81 % omega-3 (n-3) HUFA for 12 weeks
|
|---|---|---|---|
|
Proportion of n-3 HUFA Docosahexaenoic Acid (DHA)
|
1.40 Percentage of total fatty acids
Standard Error 0.11
|
1.38 Percentage of total fatty acids
Standard Error 0.09
|
1.99 Percentage of total fatty acids
Standard Error 0.11
|
Adverse Events
Diet A: Low Omega-3 (n-3) + High Linoleic Acid (LA)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Diet B: Low Omega-3 (n-3) + Low Linoleic Acid (LA)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Diet C: High Omega-3 (n-3) + Low Linoleic Acid (LA)
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