Trial Outcomes & Findings for Effect of Plant Sterols Esterified to Fish Oil Fatty Acids on Plasma Lipid Levels (NCT NCT00441480)

NCT ID: NCT00441480

Last Updated: 2012-01-13

Results Overview

Average of blood test results at -10 and 0 days (before and after run-in period)

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 91 participants
• Primary outcome timeframe: at baseline
• Results posted on: 2012-01-13

Participant Flow

Recruitment period:r May 2007-Jan 2008 (8 months) Medical center

10 -14 days run-in phase during which they received placebo capsules. Run-in phase enabled to exclude subjects who had an unstable weight (gained or lost more than 3 kg) during this period or who didn't meet entry criteria of LDL-c and TG at screening visit and at baseline visit.

Participant milestones

Measure	PS-FO plant sterols esterified to fish oil fatty acids	Control Corn oil
Overall Study STARTED	46	45
Overall Study COMPLETED	43	41
Overall Study NOT COMPLETED	3	4

Reasons for withdrawal

Measure	PS-FO plant sterols esterified to fish oil fatty acids	Control Corn oil
Overall Study Protocol Violation	1	1
Overall Study Withdrawal by Subject	2	3

Baseline Characteristics

Effect of Plant Sterols Esterified to Fish Oil Fatty Acids on Plasma Lipid Levels

Baseline characteristics by cohort

Measure	PS-FO n=46 Participants plant sterols esterified to fish oil fatty acids	Control n=45 Participants Corn oil	Total n=91 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
Age, Categorical Between 18 and 65 years	41 Participants n=5 Participants	43 Participants n=7 Participants	84 Participants n=5 Participants
Age, Categorical >=65 years	5 Participants n=5 Participants	2 Participants n=7 Participants	7 Participants n=5 Participants
Age Continuous	51 years STANDARD_DEVIATION 10.8 • n=5 Participants	49.4 years STANDARD_DEVIATION 9.3 • n=7 Participants	50.2 years STANDARD_DEVIATION 10.1 • n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants	11 Participants n=7 Participants	20 Participants n=5 Participants
Sex: Female, Male Male	37 Participants n=5 Participants	34 Participants n=7 Participants	71 Participants n=5 Participants
Region of Enrollment Israel	46 participants n=5 Participants	45 participants n=7 Participants	91 participants n=5 Participants

PRIMARY outcome

Timeframe: at baseline

Population: Subjects whose body weight were changed from baseline value by more than 3 kg during the interventions or had compliance below 65% were excluded from analysis before breaking the randomization code. It was done since these changes may have a significant influence on the study end points

Average of blood test results at -10 and 0 days (before and after run-in period)

Outcome measures

Measure	PS-FO n=34 Participants plant sterols esterified to fish oil fatty acids	Control n=33 Participants Corn oil
LDL Cholesterol	159.7 mg/dl Standard Deviation 17.22	157.8 mg/dl Standard Deviation 15.54

PRIMARY outcome

Timeframe: 12 weeks

Population: Subjects whose body weight were changed from baseline value by more than 3 kg during the interventions or had compliance below 65% were excluded from analysis before breaking the randomization code. It was done since these changes may have a significant influence on the study end points

Blood test results following 12 weeks of intervention

Outcome measures

Measure	PS-FO n=34 Participants plant sterols esterified to fish oil fatty acids	Control n=33 Participants Corn oil
LDL-C	154.7 md/dl Standard Deviation 21.0	155.1 md/dl Standard Deviation 20.1

SECONDARY outcome

Timeframe: at baseline

Population: Subjects whose body weight were changed from baseline value by more than 3 kg during the interventions or had compliance below 65% were excluded from analysis before breaking the randomization code. It was done since these changes may have a significant influence on the study end points

Average of blood test results at -10 and 0 weeks (before and after run-in period)

Outcome measures

Measure	PS-FO n=34 Participants plant sterols esterified to fish oil fatty acids	Control n=33 Participants Corn oil
Triglycerides	244.9 mg/dl Standard Deviation 83.2	248.9 mg/dl Standard Deviation 65.4

SECONDARY outcome

Timeframe: 12 weeks

Population: Subjects whose body weight were changed from baseline value by more than 3 kg during the interventions or had compliance below 65% were excluded from analysis before breaking the randomization code. It was done since these changes may have a significant influence on the study end points

Blood test results following 12 weeks of intervention

Outcome measures

Measure	PS-FO n=34 Participants plant sterols esterified to fish oil fatty acids	Control n=33 Participants Corn oil
Triglycerides	193.9 mg/dl Standard Deviation 77.0	233.0 mg/dl Standard Deviation 95.0

SECONDARY outcome

Timeframe: at baseline

Population: Subjects whose body weight were changed from baseline value by more than 3 kg during the interventions or had compliance below 65% were excluded from analysis before breaking the randomization code. It was done since these changes may have a significant influence on the study end points

Average of blood test results at -10 and 0 weeks (before and after run-in period)

Outcome measures

Measure	PS-FO n=34 Participants plant sterols esterified to fish oil fatty acids	Control n=33 Participants Corn oil
Total Cholesterol	244.3 mg/dl Standard Deviation 24.7	239.6 mg/dl Standard Deviation 22.7

SECONDARY outcome

Timeframe: 12 weeks

Population: Subjects whose body weight were changed from baseline value by more than 3 kg during the interventions or had compliance below 65% were excluded from analysis before breaking the randomization code. It was done since these changes may have a significant influence on the study end points

Blood test results following 12 weeks of intervention

Outcome measures

Measure	PS-FO n=34 Participants plant sterols esterified to fish oil fatty acids	Control n=33 Participants Corn oil
Total Cholesterol	233.8 mg/dl Standard Deviation 28.0	236.5 mg/dl Standard Deviation 27.7

SECONDARY outcome

Timeframe: at baseline

Population: Subjects whose body weight were changed from baseline value by more than 3 kg during the interventions or had compliance below 65% were excluded from analysis before breaking the randomization code. It was done since these changes may have a significant influence on the study end points

Average of blood test results at -10 and 0 weeks (before and after run-in period)

Outcome measures

Measure	PS-FO n=34 Participants plant sterols esterified to fish oil fatty acids	Control n=33 Participants Corn oil
HDL Cholesterol	46.0 mg/dl Standard Deviation 9.1	44.2 mg/dl Standard Deviation 7.7

SECONDARY outcome

Timeframe: 12 weeks

Population: Subjects whose body weight were changed from baseline value by more than 3 kg during the interventions or had compliance below 65% were excluded from analysis before breaking the randomization code. It was done since these changes may have a significant influence on the study end points

Blood test results following 12 weeks of intervention

Outcome measures

Measure	PS-FO n=34 Participants plant sterols esterified to fish oil fatty acids	Control n=33 Participants Corn oil
HDL-cholestrol	46.4 mg/dl Standard Deviation 9.8	44.7 mg/dl Standard Deviation 10.5

SECONDARY outcome

Timeframe: at baseline

Population: Subjects whose body weight were changed from baseline value by more than 3 kg during the interventions or had compliance below 65% were excluded from analysis before breaking the randomization code. It was done since these changes may have a significant influence on the study end points

Blood test results on day 0 of High sensitivity C Reactive Protein

Outcome measures

Measure	PS-FO n=34 Participants plant sterols esterified to fish oil fatty acids	Control n=33 Participants Corn oil
CRP	3.07 mg/l Standard Deviation 3.45	3.25 mg/l Standard Deviation 2.61

SECONDARY outcome

Timeframe: 12 weeks

Population: Subjects whose body weight were changed from baseline value by more than 3 kg during the interventions or had compliance below 65% were excluded from analysis before breaking the randomization code. It was done since these changes may have a significant influence on the study end points

Blood test results following 12 weeks of intervention of High sensetivity C reactive protein

Outcome measures

Measure	PS-FO n=34 Participants plant sterols esterified to fish oil fatty acids	Control n=33 Participants Corn oil
CRP	2.47 mg/l Standard Deviation 2.45	4.51 mg/l Standard Deviation 4.15

SECONDARY outcome

Timeframe: at baseline

Population: Subjects whose body weight were changed from baseline value by more than 3 kg during the interventions or had compliance below 65% were excluded from analysis before breaking the randomization code. It was done since these changes may have a significant influence on the study end points

Blood test results on day 0

Outcome measures

Measure	PS-FO n=34 Participants plant sterols esterified to fish oil fatty acids	Control n=33 Participants Corn oil
Apolipoprotein B100	130.6 mg/dl Standard Deviation 15.7	129.4 mg/dl Standard Deviation 14.3

SECONDARY outcome

Timeframe: 12 weeks

Population: Subjects whose body weight were changed from baseline value by more than 3 kg during the interventions or had compliance below 65% were excluded from analysis before breaking the randomization code. It was done since these changes may have a significant influence on the study end points

Blood test results follwing 12 weeks of intervention

Outcome measures

Measure	PS-FO n=34 Participants plant sterols esterified to fish oil fatty acids	Control n=33 Participants Corn oil
Apolipoprotein B100	130.0 mg/dl Standard Deviation 19.1	130.3 mg/dl Standard Deviation 17.0

SECONDARY outcome

Timeframe: at baseline

Population: Subjects whose body weight were changed from baseline value by more than 3 kg during the interventions or had compliance below 65% were excluded from analysis before breaking the randomization code. It was done since these changes may have a significant influence on the study end points

Blood test on day 0

Outcome measures

Measure	PS-FO n=34 Participants plant sterols esterified to fish oil fatty acids	Control n=33 Participants Corn oil
Apolipoprotein A	126.3 mg/dl Standard Deviation 13.5	125.6 mg/dl Standard Deviation 13.6

SECONDARY outcome

Timeframe: 12 weeks

Population: Subjects whose body weight were changed from baseline value by more than 3 kg during the interventions or had compliance below 65% were excluded from analysis before breaking the randomization code. It was done since these changes may have a significant influence on the study end points

Blood test results following 12 weeks of intervention

Outcome measures

Measure	PS-FO n=34 Participants plant sterols esterified to fish oil fatty acids	Control n=33 Participants Corn oil
Apolipoprotein A	128.2 mg/dl Standard Deviation 14.5	127.8 mg/dl Standard Deviation 16.3

Adverse Events

PS-FO

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Control

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	PS-FO n=46 participants at risk plant sterols esterified to fish oil fatty acids	Control n=45 participants at risk Corn oil
Gastrointestinal disorders abdominal discomfort	0.00% 0/46	2.2% 1/45 • Number of events 1
Skin and subcutaneous tissue disorders Itching rash	2.2% 1/46 • Number of events 1	0.00% 0/45

Additional Information

Prof. Dror Harats

The Institute for Lipid and Atherosclerosis Research and Internal Medicine C, Sheba Medical Center, Tel Hashomer

Phone: 972-3-5302940

Email: dror@vbl.co.il

Results disclosure agreements

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