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Evaluation of the effects of Krill Oil on the Clinical Course of Hyperlipidemia

JSS medical research inc. June 7, 2003

 

Abstract

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: 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. KO is effective for the management of hyperlipidemia by significantly reducing total cholesterol, LDL and triglycerides and increasing HDL levels.

2. KO 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, KO 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.

 

Text Box: Percent ChangeText Box: 40200-20-40

 

 

Study Description

INDICATION: Blood lipid Lowering.

OBJECTIVES: To assess the effects of Krill Oil (KO) 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 KO patients.

TREATMENT: Patients were randomly assigned to one of four groups.

1. Group A: Krill Oil (KO) 2-3 gm once daily

1. BMI <32: 2.0g per day

2. BMI >32: 3.0g per day

2. Group B1: Krill Oil (KO) 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: Krill Oil (KO) 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 KO (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 KO (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 KO SUBGROUP ANALYSIS

GROUP C1 : 2 g KO – 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 KO (0

– 90 days)

0.5 g KO (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. KO 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. KO 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. KO 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. KO 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. KO 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 KO 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.

 

 

Key concepts: Neptune Krill Oil, EPA, DHA, blood lipid lowering, cholesterol, triglycerides, LDL, HDL