Evaluation of the effects of Neptune Krill Oil on the
Clinical Course of Hyperlipidemia
JSS medical research inc. June 7,
2003
Abstract
Neptune Krill Oil was tested on a group 120
patients with mild to high hyperlipidemia (high cholesterol). In
a multi-clinical, 3-month, prospective, randomized study, the
patients were randomly assigned to 4 groups: Neptune Krill Oil
2-3 gm/day (based on BMI), 1.5-1.0 gm/day (based on BMI), an
active control group taking 3.0 gm/day fish oil, and a placebo
group.
Primary parameters tested were: total
cholesterol, triglycerides, HDL and LDL cholesterol, and
Cholesterol/HDL ratio.
The results of the present study demonstrate within high levels of
confidence that:
1. NKO™
is effective for the management of hyperlipidemia by significantly
reducing total cholesterol,
LDL and triglycerides and increasing HDL levels.
2. NKO™
1.5 gr/day is more effective than Fish Oil 3.0 gr/day for the management
of hyperlipidemia by
significantly reducing LDL levels.
3. At equal doses, NKO™
3.0 gr/day is more
effective than Fish Oil 3.0 gr/day for
the management of
hyperlipidemia by significantly reducing triglycerides and
LDL levels.
Study Description
INDICATION: Blood lipid Lowering.
OBJECTIVES: To assess the effects of Neptune Krill Oil
(NKO™) on total cholesterol, triglycerides, LDL, HDL and
cholesterol/HDL ratio.
PATIENT POPULATION: Patients with hyperlipidemia who
can maintain a healthy diet with:
· mildly high cholesterol level: between 5 to
6.4mmol/l.
· moderately high cholesterol level: between 6.5 to
7.8mmol/l.
· very high cholesterol level: 7.8 – 9.0 mmol/l.
STUDY DESIGN: A multi-clinical, 3-month, prospective,
randomized study followed by a 3 month controlled follow-up of
NKO™ patients.
TREATMENT: Patients were randomly assigned to one of
four groups.
1. Group A: Neptune Krill Oil (NKO™) 2-3 gm once daily
1. BMI <32: 2.0g per day
2. BMI >32: 3.0g per day
2. Group B1: Neptune Krill Oil (NKO™) 1.5-1.0 gm once daily
(booster dose)
1. BMI <32: 1.0g per day
2. BMI >32: 1.5g per day
3. Group B2: Neptune Krill Oil (NKO™) 0.5 gm once daily
(maintenance dose)
4. Group C: active control (18:12 EPA:DHA fish oil) (FO) 3 gm
once daily
5. Group D: placebo 1.5 gm once daily.
PRIMARY EFFICACY PARAMETER:
Primary parameters tested (baseline and 90-day visit).:
1. Cholesterol
2. Triglycerides
3. LDL Cholesterol
4. HDL Cholesterol
5. Cholesterol/HDL ratio
STATISTICAL RATIONALE AND ANALYSIS:
A sample size of 120 patients (30 patients/group) will provide
90% power to detect a 15% change in total cholesterol from
baseline to 3 months.
Within group differences reflecting changes over time for the
same patient were assessed for statistical significance with the
Paired Student’s t-test. Between group differences were assessed
with planned comparisons of one way analysis of variance.
Results:
MAIN STUDY GROUP ANALYSIS
|
GROUP A : Placebo (30 patients) |
|
|
0
days |
90
days |
%
Change |
|
|
mmol/l |
|
Total
Cholesterol |
5.74 |
6.26 |
9.06% |
|
LDL |
3.53 |
3.99 |
13.03% |
|
HDL |
1.47 |
1.47 |
0.00% |
|
Triglycerides |
1.62 |
1.46 |
-9.88% |
|
GROUP B : 3 g Fish Oil (30 patients) |
|
|
0
days 90 days |
%
Change |
|
|
mmol/l |
|
Total
Cholesterol |
4.97 |
4.88 |
-1.81% |
|
LDL |
3.08 |
3.00 |
-2.60% |
|
HDL |
1.45 |
1.52 |
4.83% |
|
Triglycerides |
0.95 |
0.91 |
-4.21% |
|
GROUP C : 2 - 3 g NKO™ (30 patients) BMI dependent |
|
|
|
0
days |
90
days |
%
Change |
|
|
|
mmol/l |
|
|
Total
Cholesterol |
6.44 |
5.28 |
-18.01% |
|
|
LDL |
4.16 |
3.39 |
-18.51% |
|
|
HDL |
1.48 |
2.33 |
57.43% |
|
|
Triglycerides |
1.77 |
1.29 |
-27.12% |
|
| |
|
|
|
|
|
|
GROUP D : 1.0 - 1.5 g NKO™ (30 patients) BMI dependent |
|
|
0
days |
90
days |
%
Change |
|
|
mmol/l |
|
Total Cholesterol |
6.04 |
5.22 |
-13.56% |
|
LDL |
3.79 |
2.82 |
-25.59% |
|
HDL |
1.50 |
2.15 |
43.46% |
|
Triglycerides |
1.39 |
1.23 |
-11.47% |
BMI DEPENDENT NKO™™ SUBGROUP ANALYSIS
|
GROUP
C1 : 2 g NKO – Subgroup of C (15 patients) |
|
|
0
days |
90
days |
% Change |
|
|
mmol/l |
|
Total
Cholesterol |
6.40 |
5.24 |
-18.13% |
|
LDL |
4.73 |
2.96 |
-37.42% |
|
HDL |
1.32 |
2.05 |
55.30% |
|
Triglycerides |
1.81 |
1.31 |
-27.62% |
|
GROUP
D1 :– Subgroup of D (17 patients) - |
|
1.0 g
NKO (0 |
– 90 days) |
0.5 g
NKO (91 – 180 days) |
|
|
0
days |
90
days |
% Change |
91 -
180 days |
% Change |
|
|
mmol/l |
mmol/l |
|
Total
Cholesterol |
6.10 5.28 |
-13.44% |
4.92 |
-19.34% |
|
LDL |
4.34 2.95 |
-32.03% |
2.93 |
-32.49% |
|
HDL |
1.48 2.13 |
43.92% |
1.96 |
32.43% |
|
Triglycerides |
1.36 1.21 |
-11.03% |
1.6 |
17.65% |
|
GROUP
D2 :– Subgroup of D (13 patients) - |
|
1.5 g
NKO (0 |
– 90
days) |
0.5 g
NKO (91 – 180 days) |
|
|
0
days |
90
days |
% Change |
90 -
180 days |
% Change |
|
|
|
mmol/l |
mmol/l |
|
Total
Cholesterol |
5.98 |
5.16 |
-13.71% |
4.88 |
-18.39% |
|
LDL |
4.26 |
2.74 |
-35.70% |
2.85 |
-33.10% |
|
HDL |
1.52 |
2.17 |
42.76% |
2.01 |
32.24% |
|
Triglycerides |
1.43 |
1.26 |
-11.89% |
1 |
-30.07% |
Analysis
:
The
results of the present study indicate that:
1. NKO™
1.0 - 1.5 gr/day
(BMI dependent) is significantly effective for the
reduction of:
a. Glucose
b. Total cholesterol
c. Low Density Lipoprotein
(LDL)
and
increase of High Density Lipoprotein (HDL)
2. NKO™
2.0 - 3.0 gr/day (BMI dependent) is significantly effective
for the reduction of:
a. Glucose
b. Total cholesterol
c. Triglycerides
d. Low Density Lipoprotein (LDL)
e. Cholesterol : HDL ratio
and
increase of High Density Lipoprotein (HDL)
3.
Fish Oil 3.0 gr/day (recommended dose) is significantly
effective for the reduction of:
a. Total cholesterol
b. Low Density
Lipoprotein (LDL)
c. Cholesterol : HDL
ratio
and
increase of High Density Lipoprotein (HDL)
4. NKO™ 1.0 - 1.5
gr/day (BMI dependent) is significantly more effective than Fish
Oil 3.0 gr/day for the reduction of:
a. Glucose
b. Low Density Lipoprotein (LDL)
5. NKO™
2.0 - 3.0 gr/day (BMI
dependent) is significantly more effective than Fish
Oil 3.0 gr/day for the
reduction of:
a. Glucose
b. Triglycerides
c. Low Density
Lipoprotein (LDL)
6. NKO™
at a maintenance dose
of 0.5 gr/day is significantly effective for
maintenance within normal
ranges of:
a. Glucose
b. Total cholesterol
c. Triglycerides
d. Low Density Lipoprotein (LDL)
e. Cholesterol : HDL ratio
f. High Density Lipoprotein (HDL)
Recommended
Dosage:
According to the results of the present
study, the recommended dose of
Neptune Krill Oil for the management of blood
lipids and glucose within normal levels is 1.01.5g/day (BMI
dependent) for 30 days (booster dose) and continuing with a
maintenance dose of 0.5g/day.
Conclusion
The results of the present study demonstrate within high levels of
confidence that:
1. NKO™
is effective for the management of hyperlipidemia by significantly
reducing total cholesterol,
LDL and triglycerides and increasing HDL levels.
2. NKO™
1.5 gr/day is more effective than Fish Oil 3.0 gr/day for the management
of hyperlipidemia by
significantly reducing LDL levels.
3. At equal doses, NKO™
3.0 gr/day is more
effective than Fish Oil 3.0 gr/day for
the management of
hyperlipidemia by significantly reducing triglycerides and
LDL levels.
Source:
Evaluation of the effects of Neptune krill oil on the
clinical course of hyperlipidemia
Alternative Medicine Review, Dec, 2004 by Ruxandra Bunea,
Khassan El Farrah, Luisa Deutsch
Read the entire study at
http://findarticles.com/p/articles/mi_m0FDN/is_4_9/ai_n9485702
Key concepts: Neptune Krill Oil, EPA, DHA, blood lipid
lowering, cholesterol, triglycerides, LDL, HDL
