Trial Outcomes & Findings for Dietary Fat, Eicosanoids and Breast Cancer Risk (NCT NCT01824498)

NCT ID: NCT01824498

Last Updated: 2018-08-31

Results Overview

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 18 participants
• Primary outcome timeframe: 8 weeks
• Results posted on: 2018-08-31

Participant Flow

• 6 * 137 participants screened, 66 did not meet criteria, 71 were eligible but 39 declined participation,32 screened in clinic but 2 didn't meet eligibility on further screen and 6 declined participation

Subjects enrolled prior to randomization (N=18)

Participant milestones

Measure	Low Fat, High Fat, Low Fat High Omega 3 Low Fat = 20% fat High Fat = 40% fat Low Fat, high n3 diet = 20% fat + 3% n3	Low Fat, Low Fat High Omega 3, High Fat Low Fat = 20% fat High Fat = 40% fat Low Fat, high n3 diet = 20% fat + 3% n3	High Fat, Low Fat, Low Fat High Omega 3 Low Fat = 20% fat High Fat = 40% fat Low Fat, high n3 diet = 20% fat + 3% n3	High Fat, Low Fat High Omega 3, Low Fat Low Fat = 20% fat High Fat = 40% fat Low Fat, high n3 diet = 20% fat + 3% n3	Low Fat High Omega 3, High Fat, Low Fat Low Fat = 20% fat High Fat = 40% fat Low Fat, high n3 diet = 20% fat + 3% n3	Low Fat High Omega 3, Low Fat, High Fat Low Fat = 20% fat High Fat = 40% fat Low Fat, high n3 diet = 20% fat + 3% n3
1st Intervention (8 Weeks) STARTED	5	2	6	3	4	4
1st Intervention (8 Weeks) COMPLETED	5	2	6	3	4	4
1st Intervention (8 Weeks) NOT COMPLETED	0	0	0	0	0	0
Washout (8 Weeks) STARTED	3	2	4	2	3	4
Washout (8 Weeks) COMPLETED	3	2	4	2	3	4
Washout (8 Weeks) NOT COMPLETED	0	0	0	0	0	0
2nd Intervention (8 Weeks) STARTED	3	2	4	2	3	4
2nd Intervention (8 Weeks) COMPLETED	3	2	4	2	3	4
2nd Intervention (8 Weeks) NOT COMPLETED	0	0	0	0	0	0
3rd Intervention (8 Weeks) STARTED	3	2	4	2	3	4
3rd Intervention (8 Weeks) COMPLETED	3	2	4	2	3	4
3rd Intervention (8 Weeks) NOT COMPLETED	0	0	0	0	0	0

Reasons for withdrawal

Measure	Low Fat, High Fat, Low Fat High Omega 3 Low Fat = 20% fat High Fat = 40% fat Low Fat, high n3 diet = 20% fat + 3% n3	Low Fat, Low Fat High Omega 3, High Fat Low Fat = 20% fat High Fat = 40% fat Low Fat, high n3 diet = 20% fat + 3% n3	High Fat, Low Fat, Low Fat High Omega 3 Low Fat = 20% fat High Fat = 40% fat Low Fat, high n3 diet = 20% fat + 3% n3	High Fat, Low Fat High Omega 3, Low Fat Low Fat = 20% fat High Fat = 40% fat Low Fat, high n3 diet = 20% fat + 3% n3	Low Fat High Omega 3, High Fat, Low Fat Low Fat = 20% fat High Fat = 40% fat Low Fat, high n3 diet = 20% fat + 3% n3	Low Fat High Omega 3, Low Fat, High Fat Low Fat = 20% fat High Fat = 40% fat Low Fat, high n3 diet = 20% fat + 3% n3
Washout (8 Weeks) Withdrawal by Subject	2	0	2	1	1	0

Baseline Characteristics

Dietary Fat, Eicosanoids and Breast Cancer Risk

Baseline characteristics by cohort

Measure	Low Fat, High Fat, Low Fat High Omega 3 n=5 Participants Low Fat = 20% fat High Fat = 40% fat Low Fat, high n3 diet = 20% fat + 3% n3	Low Fat, Low Fat High Omega 3, High Fat n=2 Participants Low Fat = 20% fat High Fat = 40% fat Low Fat, high n3 diet = 20% fat + 3% n3	High Fat, Low Fat, Low Fat High Omega 3 n=6 Participants Low Fat = 20% fat High Fat = 40% fat Low Fat, high n3 diet = 20% fat + 3% n3	High Fat, Low Fat High Omega 3, Low Fat n=3 Participants Low Fat = 20% fat High Fat = 40% fat Low Fat, high n3 diet = 20% fat + 3% n3	Low Fat High Omega 3, High Fat, Low Fat n=4 Participants Low Fat = 20% fat High Fat = 40% fat Low Fat, high n3 diet = 20% fat + 3% n3	Low Fat High Omega 3, Low Fat, High Fat n=4 Participants Low Fat = 20% fat High Fat = 40% fat Low Fat, high n3 diet = 20% fat + 3% n3	Total n=24 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	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants
Age, Categorical Between 18 and 65 years	5 Participants n=5 Participants	2 Participants n=7 Participants	6 Participants n=5 Participants	3 Participants n=4 Participants	4 Participants n=21 Participants	4 Participants n=10 Participants	24 Participants n=115 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	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants
Age, Continuous	57 years STANDARD_DEVIATION 2 • n=5 Participants	57 years STANDARD_DEVIATION 2 • n=7 Participants	57 years STANDARD_DEVIATION 2 • n=5 Participants	57 years STANDARD_DEVIATION 2 • n=4 Participants	57 years STANDARD_DEVIATION 2 • n=21 Participants	57 years STANDARD_DEVIATION 2 • n=10 Participants	57 years STANDARD_DEVIATION 2 • n=115 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	2 Participants n=7 Participants	6 Participants n=5 Participants	3 Participants n=4 Participants	4 Participants n=21 Participants	4 Participants n=10 Participants	24 Participants n=115 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	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants
Region of Enrollment United States	5 participants n=5 Participants	2 participants n=7 Participants	6 participants n=5 Participants	3 participants n=4 Participants	4 participants n=21 Participants	4 participants n=10 Participants	24 participants n=115 Participants

PRIMARY outcome

Timeframe: 8 weeks

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 8 weeks

Estradiol

Outcome measures

Measure	High Fat Diet n=18 Participants Hig fat diet = 40% fat	Low Fat Diet n=18 Participants Low fat diet = 20% fat	Low Fat, High n3 Diet n=18 Participants Low fat, n3 diet = 20% fat + 3% n3
E2	52.8 pmol/L Standard Error 5.1	35.6 pmol/L Standard Error 5.4	39.8 pmol/L Standard Error 5.1

Adverse Events

High Fat Diet

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Low Fat Diet

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Low Fat, High n3 Diet

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

Susan Raatz, PhD, RD

USDA, GFHNRC

Phone: 701-795-8294

Email: susan.raatz@ars.usda.gov

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place