LipidShield™ – Clinical Trials Completed!

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Final Statistical Report
LipidShield Study
June 28, 2006

 

Performed by

The Ohio Research Group
323 High Street, STE 103
Wadsworth, OH 44281
tel: 330-335-2378

Tim N. Ziegenfuss, Ph.D., Ronald W. Mendel, Ph.D., and Jennifer E. Hofheins, M.S., R.D. Cholesterol-lowering effects of LipidShield™. Ohio Research Group. Wadsworth, Ohio 44281, USA. tim@ohioresearchgroup.com

Objective:

The purpose of this placebo-controlled, double-blind study was to determine the effect of supplementation with a proprietary cholesterol-lowering formula (LipidShield™) on changes in lipid profiles.

Methods:

After giving informed consent and being cleared for participation by passing a screening physical, 30 men and women (mean ± SD age, weight, total cholesterol: 39.6 ± 5.8 y, 84.49 ± 16.2 kg, 226 ± 31 mg/dl) were matched according to gender and then randomly assigned to receive either (LipidShield™, LS) or a placebo (P). Following baseline testing, all groups underwent eight weeks of daily supplementation per recommendation by the manufacturer. Blood samples were obtained at baseline, and after 4-weeks (day 28) and 8-weeks (day 56) of supplementation. Subjects were required to maintain their normal dietary and exercise patterns during the study. Data were analyzed via two-way, repeated measures ANOVA and (where necessary) Newman-Keuls post-hoc tests. Statistical significance was accepted at p=0.05.

Results:

Total cholesterol decreased in LS from pre to mid (-8.8%; 234.1 ± 34.1 [baseline] to 215.2 ± 35.0 mg/dl [day 28], p<0.0009) and pre to post (-17.3%; 234.1 ± 34.1 [baseline] to 199.6 ± 34.9 mg/dl [day 56], p<0.0001), whereas cholesterol increased from pre to post in P (+6.9%; 218.4 ± 26.4 [baseline] to 234.6 ± 26.8 mg/dl [day 56], p<0.004). LDL-cholesterol decreased from pre to mid (-13.5%; 145.7 ± 29.3 [baseline] to 126.1 ± 28.6 mg/dl [day 28], p<0.001) and pre to post (-16.9%; 145.7 ± 29.3 [baseline] to 121.1 ± 31.1 mg/dl [day 56], p<0.0002) in LS, whereas no changes were noted in P. VLDL-cholesterol tended to decrease in LS from pre to post (-23.6%; 33.9 ± 14.5 [baseline] to 25.9 ± 12.6 mg/dl [day 56], p<0.065). Triacylglycerol (TAG) decreased in LS from pre to post testing (-46.9%; 169.5 ± 72.1 [baseline] to 115.3 ± 42.4 mg/dl [day 56], p<0.009), whereas no changes were noted in P. No changes in HDL-cholesterol, glucose, BUN, creatinine, BUN:creatinine ratio, alkaline phosphatase, aspartate aminotransferase, or alanine aminotransferase were noted in either group.

Conclusions:

Within the framework of the current experimental design, these preliminary data indicate that eight weeks of LipidShield™ ingestion significantly decreases and improves several aspects of blood lipids (e.g., total cholesterol, VLDL-cholesterol, and triglycerides) in otherwise healthy, hypercholesterolemic subjects. Based on the lack of changes in standard clinical markers of hepato-renal function, the safety profile of LipidShield™ appears to be acceptable, at least during eight weeks of continuous use. Future research is warranted to confirm and refine these results in a larger sample size, as well as determine the mechanisms responsible for the noted improvements.

Supported in part by a research grant from New Health Corp (Melbourne, FL).
None of the authors have any conflict of interest.
 

Descriptive Statistics – Placebo (group X)
 

 

Valid N

Mean

Minimum

Maximum

Variance

SD

SE

Age

15 40.4000 31.0000 49.0000 25.686 5.06811 1.30858

Ht

15 66.1333 59.0000 76.0000 19.588 4.42584 1.14275

Wt (pre)

15 83.4600 56.8000 101.1000 164.145 12.81193 3.30802

Wt (mid)

15 83.5867 57.1000 103.1000 174.040 13.19241 3.40627

Wt (post)

15 83.5000 56.9000 102.8000 179.414 13.39456 3.45846

Systolic (pre)

15 127.8000 102.0000 155.0000 225.314 15.01047 3.87569

Systolic (mid)

15 127.3333 102.0000 154.0000 203.524 14.26618 3.68351

Systolic (post)

15 129.4667 102.0000 159.0000 277.124 16.64704 4.29825

Diastolic (pre)

15 81.2000 60.0000 94.0000 119.029 10.91002 2.81696

Diastolic (mid)

15 82.6000 65.0000 94.0000 86.971 9.32585 2.40792

Diastolic (post)

15 80.4000 61.0000 96.0000 112.543 10.60862 2.73913

Total Chol (pre)

15 218.4000 195.0000 301.0000 698.400 26.42726 6.82349

Total Chol (mid)

15 220.9333 181.0000 296.0000 886.924 29.78127 7.68949

Total Chol (post)

15 234.6000 192.0000 296.0000 716.686 26.77099 6.91224

TAG (pre)

15 127.0667 52.0000 234.0000 2878.067 53.64762 13.85175

TAG (mid)

15 120.6000 57.0000 205.0000 2152.686 46.39704 11.97967

TAG (post)

15 147.9333 67.0000 332.0000 6068.352 77.89963 20.11360

HDL (pre)

15 53.0667 41.0000 77.0000 85.067 9.22316 2.38141

HDL (mid)

15 56.3333 35.0000 105.0000 241.095 15.52724 4.00912

HDL (post)

15 56.4667 35.0000 105.0000 248.410 15.76101 4.06948

VLDL (pre)

15 25.3333 10.0000 47.0000 118.238 10.87373 2.80759

VLDL (mid)

15 24.0000 11.0000 41.0000 85.143 9.22729 2.38248

VLDL (post)

15 27.8667 13.0000 66.0000 238.410 15.44052 3.98672

LDL (pre)

15 131.2000 36.0000 194.0000 1012.029 31.81240 8.21393

LDL (mid)

15 131.6667 37.0000 199.0000 1054.952 32.48003 8.38631

LDL (post)

15 141.2000 37.0000 199.0000 1444.600 38.00789 9.81360

Glucose (pre)

15 92.7333 83.0000 108.0000 42.924 6.55163 1.69162

Glucose (mid)

15 92.1333 80.0000 105.0000 60.267 7.76316 2.00444

Glucose (post)

15 92.4667 78.0000 116.0000 105.552 10.27387 2.65270

BUN (pre)

15 14.1333 9.0000 22.0000 21.838 4.67312 1.20660

BUN (mid)

15 15.0667 9.0000 25.0000 22.067 4.69752 1.21289

BUN (post)

15 16.2000 10.0000 30.0000 33.314 5.77185 1.49029

Creatinine (pre)

15 0.9733 0.7000 1.6000 0.068 0.26040 0.06724

Creatinine (mid)

15 0.9467 0.7000 1.5000 0.057 0.23865 0.06162

Creatinine (post)

15 0.9467 0.7000 1.4000 0.038 0.19591 0.05058

B/C ratio (Pre)

15 14.5333 11.0000 20.0000 6.267 2.50333 0.64636

B/C ratio (Mid)

15 16.3333 12.0000 23.0000 13.381 3.65800 0.94449

B/C ratio (Post)

15 17.0000 12.0000 23.0000 11.571 3.40168 0.87831

Bilirubin (pre)

15 0.4467 0.2000 0.8000 0.028 0.16847 0.04350

Bilirubin (mid)

15 0.4533 0.2000 0.9000 0.041 0.20307 0.05243

Bilirubin (post)

15 0.5600 0.2000 0.8000 0.041 0.20284 0.05237

Alkaline Phos (pre)

15 69.0667 44.0000 88.0000 183.638 13.55131 3.49893

Alkaline Phos (mid)

15 70.0000 50.0000 92.0000 181.714 13.48014 3.48056

Alkaline Phos (post)

15 68.0000 44.0000 89.0000 182.429 13.50661 3.48739

AST (Pre)

15 26.8667 12.0000 50.0000 117.267 10.82897 2.79603

AST (mid)

15 27.2667 13.0000 54.0000 116.638 10.79991 2.78853

AST (Post)

15 25.0667 16.0000 37.0000 35.352 5.94579 1.53520

ALT (Pre)

15 24.4667 11.0000 38.0000 83.552 9.14070 2.36012

ALT (mid)

15 24.3333 13.0000 40.0000 100.381 10.01903 2.58690

ALT (Post)

15 23.1333 10.0000 42.0000 77.124 8.78202 2.26751

Descriptive Statistics – LipidShield (group Y)
 

 

Valid N

Mean

Minimum

Maximum

Variance

SD

SE

Age

15 38.8667 29.0000 48.0000 43.838 6.62103 1.70954

Ht

15 66.7000 62.0000 74.0000 13.850 3.72156 0.96090

Wt (pre)

15 85.5200 59.7000 136.4000 374.653 19.35596 4.99769

Wt (mid)

15 85.3267 59.9000 137.0000 378.806 19.46295 5.02531

Wt (post)

15 85.0933 60.3000 137.1000 381.144 19.52290 5.04079

Systolic (pre)

15 134.2000 110.0000 159.0000 173.171 13.15946 3.39776

Systolic (mid)

15 130.8000 104.0000 151.0000 158.029 12.57094 3.24580

Systolic (post)

15 129.8000 103.0000 156.0000 199.314 14.11787 3.64522

Diastolic (pre)

15 82.2667 72.0000 93.0000 47.638 6.90204 1.78210

Diastolic (mid)

15 80.8000 70.0000 93.0000 52.886 7.27226 1.87769

Diastolic (post)

15 79.0667 68.0000 89.0000 46.638 6.82921 1.76329

Total Chol (pre)

15 234.0667 198.0000 296.0000 1160.638 34.06814 8.79636

Total Chol (mid)

15 215.2000 174.0000 308.0000 1225.600 35.00857 9.03917

Total Chol (post)

15 199.6000 156.0000 289.0000 1222.400 34.96284 9.02737

TAG (pre)

15 169.4667 62.0000 308.0000 5192.838 72.06135 18.60616

TAG (mid)

15 157.0000 68.0000 326.0000 5830.286 76.35631 19.71511

TAG (post)

15 115.2667 73.0000 212.0000 1795.352 42.37160 10.94030

HDL (pre)

15 54.4000 35.0000 76.0000 200.686 14.16636 3.65774

HDL (mid)

15 54.8000 37.0000 77.0000 173.743 13.18116 3.40336

HDL (post)

15 52.6000 26.0000 77.0000 193.543 13.91197 3.59205

VLDL (pre)

15 33.9333 12.0000 62.0000 210.924 14.52322 3.74988

VLDL (mid)

15 34.2667 14.0000 74.0000 349.067 18.68333 4.82401

VLDL (post)

15 25.9333 15.0000 58.0000 159.210 12.61783 3.25791

LDL (pre)

15 145.7333 101.0000 198.0000 860.495 29.33420 7.57406

LDL (mid)

15 126.1333 100.0000 207.0000 819.695 28.63032 7.39232

LDL (post)

15 121.0667 89.0000 198.0000 967.067 31.09770 8.02939

Glucose (pre)

15 92.6667 78.0000 111.0000 104.381 10.21670 2.63794

Glucose (mid)

15 91.0000 81.0000 101.0000 44.000 6.63325 1.71270

Glucose (post)

15 90.4000 74.0000 117.0000 85.543 9.24894 2.38807

BUN (pre)

15 13.4000 6.0000 27.0000 24.829 4.98283 1.28656

BUN (mid)

15 14.4667 9.0000 25.0000 23.838 4.88243 1.26064

BUN (post)

15 13.6000 8.0000 23.0000 16.971 4.11964 1.06369

Creatinine (pre)

15 1.0000 0.6000 2.6000 0.211 0.45981 0.11872

Creatinine (mid)

15 0.9067 0.7000 1.2000 0.021 0.14376 0.03712

Creatinine (post)

15 0.9200 0.7000 1.3000 0.027 0.16562 0.04276

B/C ratio (Pre)

15 14.6667 6.0000 30.0000 40.524 6.36583 1.64365

B/C ratio (Mid)

15 15.8667 9.0000 25.0000 20.981 4.58050 1.18268

B/C ratio (Post)

15 14.8000 10.0000 25.0000 17.029 4.12657 1.06548

Bilirubin (pre)

15 0.4533 0.3000 0.8000 0.037 0.19223 0.04963

Bilirubin (mid)

15 0.4467 0.2000 0.8000 0.030 0.17265 0.04458

Bilirubin (post)

15 0.4133 0.2000 0.8000 0.040 0.19952 0.05152

Alkaline Phos (pre)

15 71.6000 42.0000 93.0000 202.257 14.22171 3.67203

Alkaline Phos (mid)

15 70.0667 42.0000 96.0000 278.210 16.67961 4.30666

Alkaline Phos (post)

15 69.8667 45.0000 96.0000 189.981 13.78336 3.55885

AST (Pre)

15 23.4000 16.0000 42.0000 52.971 7.27815 1.87921

AST (mid)

15 22.6000 13.0000 34.0000 24.114 4.91063 1.26792

AST (Post)

15 21.3333 9.0000 33.0000 37.952 6.16055 1.59065

ALT (Pre)

15 25.2000 11.0000 59.0000 192.314 13.86774 3.58064

ALT (mid)

15 23.4000 9.0000 39.0000 51.829 7.19921 1.85883

ALT (Post)

15 20.2000 7.0000 39.0000 87.029 9.32891 2.40871

Inferential Statistics

Independent t-tests were used to test for between group differences at baseline (none were found, although trends were noted for TAG and VLDL).

 

 

Mean X

Mean Y

t-value

df

p

Wt (pre)

83.4600 85.5200 -0.34372 28 0.733628

Systolic (pre)

127.8000 134.2000 -1.24171 28 0.224646

Diastolic (pre)

81.2000 82.2667 -0.32000 28 0.751344

Total Chol (pre)

218.4000 234.0667 -1.40727 28 0.170351

TAG (pre)

127.0667 169.4667 -1.82789 28 0.078240

HDL (pre)

53.0667 54.4000 -0.30548 28 0.762257

VLDL (pre)

25.3333 33.9333 -1.83586 28 0.077020

LDL (pre)

131.2000 145.7333 -1.30076 28 0.203945

Glucose (pre)

92.7333 92.6667 0.02127 28 0.983178

BUN (pre)

14.1333 13.4000 0.41576 28 0.680754

Creatinine (pre)

0.9733 1.0000 -0.19545 28 0.846455

B/C ratio (Pre)

14.5333 14.6667 -0.07549 28 0.940359

Bilirubin (pre)

0.4467 0.4533 -0.10102 28 0.920258

Alkaline Phos (pre)

69.0667 71.6000 -0.49946 28 0.621355

AST (Pre)

26.8667 23.4000 1.02903 28 0.312272

ALT (Pre)

24.4667 25.2000 -0.17100 28 0.865453

A series of 3-way ANOVAs (group x gender x time) were run to determine if any gender effects were present in the data. No 3-way interactions were found, thus the remaining analyses are 2-way (group x time) ANOVAs. When a significant interaction was found, Newman-Keuls post-hoc tests were used as a discriminatory follow-up.

 

Interpretation:

No significant differences between groups over time were noted for this variable (body weight).

 

Newman-Keuls test; variable DV_1 (LipidShield Final Data) Approximate Probabilities for Post Hoc Tests Error: Between; Within; Pooled MS = 985.11, df = 34.938

 

Grp

TIME

{1}

{2}

{3}

{4}

{5}

{6}

1

x Total Chol (pre)   0.585254 0.004898 0.684451 0.781854 0.242638

2

x Total Chol (mid) 0.585254   0.012359 0.259711 0.949934 0.263032

3

x Total Chol (post) 0.004898 0.012359   0.963256 0.451453 0.442212

4

y Total Chol (pre) 0.684451 0.259711 0.963256   0.000909 0.000129

5

y Total Chol (mid) 0.781854 0.949934 0.451453 0.000909   0.001440

6

y Total Chol (post) 0.242638 0.263032 0.442212 0.000129 0.001440  

Interpretation:

Subjects in group Y (LipidShield) had significant decreases in their total cholesterol from pre to mid, and pre to post testing. Also, subjects in group X (placebo) had a significant increase in their total cholesterol from pre to post testing.

 

Newman-Keuls test; variable DV_1 (LipidShield Final Data) Approximate Probabilities for Post Hoc Tests Error: Between; Within; Pooled MS = 3986.3, df = 51.208

 

Grp

TIME

{1}

{2}

{3}

{4}

{5}

{6}

1

x TAG (pre)   0.672083 0.175120 0.595415 0.402674 0.866007

2

x TAG (mid) 0.672083   0.179199 0.227752 0.703590 0.818092

3

x TAG (post) 0.175120 0.179199   0.621562 0.695881 0.767181

4

y TAG (pre) 0.595415 0.227752 0.621562   0.415446 0.009372

5

y TAG (mid) 0.402674 0.703590 0.695881 0.415446   0.059599

6

y TAG (post) 0.866007 0.818092 0.767181 0.009372 0.059599  

Interpretation:

Subjects in group Y (LipidShield) had significant decreases in their triglycerides (TAG) from pre to post testing.

 

Interpretation:

No significant differences between groups over time were noted for this variable(HDL).

 

Newman-Keuls test; variable DV_1 (LipidShield Final Data) Approximate Probabilities for Post Hoc Tests Error: Between; Within; Pooled MS = 193.50, df = 53.921

 

Grp

TIME

{1}

{2}

{3}

{4}

{5}

{6}

1

x VLDL (pre)   0.703933 0.749213 0.643785 0.407951 0.906513

2

x VLDL (mid) 0.703933   0.686108 0.301523 0.721157 0.923440

3

x VLDL (post) 0.749213 0.686108   0.237640 0.423832 0.792733

4

y VLDL (pre) 0.643785 0.301523 0.237640   0.924334 0.065164

5

y VLDL (mid) 0.407951 0.721157 0.423832 0.924334   0.091156

6

y VLDL (post) 0.906513 0.923440 0.792733 0.065164 0.091156  

Interpretation:

Although the p-value for the ANOVA was significant (p<0.03 – see top of graph), post-hoc testing only revealed a trend (p<0.065) for a decrease in VLDL in group Y (LipidShield) from pre to post testing.

 

Newman-Keuls test; variable DV_1 (LipidShield Final Data) Approximate Probabilities for Post Hoc Tests Error: Between; Within; Pooled MS = 1026.5, df = 34.995

 

Grp

TIME

{1}

{2}

{3}

{4}

{5}

{6}

1

x LDL (pre)   0.921812 0.095879 0.871792 0.667730 0.664940

2

x LDL (mid) 0.921812   0.048596 0.459782 0.955086 0.801767

3

x LDL (post) 0.095879 0.048596   0.700863 0.576661 0.828712

4

y LDL (pre) 0.871792 0.459782 0.700863   0.001167 0.000169

5

y LDL (mid) 0.667730 0.955086 0.576661 0.001167   0.288464

6

y LDL (post) 0.664940 0.801767 0.828712 0.000169 0.288464  

Interpretation:

Subjects in group Y (LipidShield) had significant decreases in their LDL from pre to mid, and pre to post testing.

 

Interpretation:

No significant differences between groups over time were noted for this variable (glucose).

 

Interpretation:

No significant differences between groups over time were noted for this variable (B/C ratio).

 

Newman-Keuls test; variable DV_1 (LipidShield Final Data) Approximate Probabilities for Post Hoc Tests Error: Between; Within; Pooled MS = .03622, df = 46.646

 

Grp

TIME

{1}

{2}

{3}

{4}

{5}

{6}

1

x Bilirubin (pre)   0.874882 0.045106 0.997832 1.000000 0.881303

2

x Bilirubin (mid) 0.874882   0.037181 1.000000 0.997832 0.938974

3

x Bilirubin (post) 0.045106 0.037181   0.131683 0.485943 0.725483

4

y Bilirubin (pre) 0.997832 1.000000 0.131683   0.998637 0.876036

5

y Bilirubin (mid) 1.000000 0.997832 0.485943 0.998637   0.432129

6

y Bilirubin (post) 0.881303 0.938974 0.725483 0.876036 0.432129  

Interpretation:

Subjects in group X (placebo) had significant increases in bilirubin from pre to post testing.

 

Interpretation:

No significant differences between groups over time were noted for this variable (Alkaline Phos).

 

Interpretation:

No significant differences between groups over time were noted for this variable (AST).

 

Interpretation:

No significant differences between groups over time were noted for this variable (ALT).

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