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Home > LipidShield Studies

Clinical Research

In a recently completed clinical study, LipidShield Plus demonstrated statistical evidence of improving several aspects of blood lipids.

LipidShield Plus™ was clinically proven to lower
LDL cholesterolby up to 34%, VLDL by up to 76%, triglyceridesby up to 76% and total cholesterol by up to 28%, while also helping to improve circulatory health.

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.

Final Statistical Report
LipidShield Study
June 28, 2006

Performed by
The Ohio Research Group
323 High Street, STE 103
Wadsworth, OH 44281
PH: 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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