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Supplements, Placebo, or Rosuvastatin Study (SPORT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04846231
Recruitment Status : Completed
First Posted : April 15, 2021
Results First Posted : May 25, 2023
Last Update Posted : May 25, 2023
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
The Cleveland Clinic

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Hypercholesterolemia
Interventions Dietary Supplement: Fish Oil, Cinnamon, Garlique,Turmeric, Plant Sterol, Red Yeast Rice
Drug: Rosuvastatin
Other: Placebo
Enrollment 203
Recruitment Details  
Pre-assignment Details 203 subjects were enrolled and 199 randomized.
Arm/Group Title Rosuvastatin Placebo Fish Oil Cinnamon Garlique Turmeric Plant Sterol Red Yeast Rice
Hide Arm/Group Description

5 mg once per day

Rosuvastatin: Subjects will be randomized to a Statin (Rosuvastatin 5 mg), a placebo, or a dietary supplement (Fish oil, Cinnamon, Garlic, Turmeric, Plant sterol, Red yeast rice).

comparable to rosuvastatin 5 mg once per day

Placebo: Subjects will be randomized to a Statin (Rosuvastatin 5 mg), a placebo, or a dietary supplement (Fish oil, Cinnamon, Garlic, Turmeric, Plant sterol, Red yeast rice).

Nature Made 2 soft gels per day

Fish Oil, Cinnamon, Garlique,Turmeric, Plant Sterol, Red Yeast Rice: Subjects will be randomized to a Statin (Rosuvastatin 5 mg), a placebo, or a dietary supplement (Fish oil, Cinnamon, Garlic, Turmeric, Plant sterol, Red yeast rice).

1200mg, 2 capsules per day

Fish Oil, Cinnamon, Garlique,Turmeric, Plant Sterol, Red Yeast Rice: Subjects will be randomized to a Statin (Rosuvastatin 5 mg), a placebo, or a dietary supplement (Fish oil, Cinnamon, Garlic, Turmeric, Plant sterol, Red yeast rice).

Manufactured by Focus Consumer Health Marketgate,1 tablet per day

Fish Oil, Cinnamon, Garlique,Turmeric, Plant Sterol, Red Yeast Rice: Subjects will be randomized to a Statin (Rosuvastatin 5 mg), a placebo, or a dietary supplement (Fish oil, Cinnamon, Garlic, Turmeric, Plant sterol, Red yeast rice).

Bio Schwartz Turmeric Curcumin 1500 mg, 3 capsules per day

Fish Oil, Cinnamon, Garlique,Turmeric, Plant Sterol, Red Yeast Rice: Subjects will be randomized to a Statin (Rosuvastatin 5 mg), a placebo, or a dietary supplement (Fish oil, Cinnamon, Garlic, Turmeric, Plant sterol, Red yeast rice).

Nature Made CholestOff Plus, 2 soft gels twice a day

Fish Oil, Cinnamon, Garlique,Turmeric, Plant Sterol, Red Yeast Rice: Subjects will be randomized to a Statin (Rosuvastatin 5 mg), a placebo, or a dietary supplement (Fish oil, Cinnamon, Garlic, Turmeric, Plant sterol, Red yeast rice).

Arazo Nutrition 1200 mg, 2 capsules per day

Fish Oil, Cinnamon, Garlique,Turmeric, Plant Sterol, Red Yeast Rice: Subjects will be randomized to a Statin (Rosuvastatin 5 mg), a placebo, or a dietary supplement (Fish oil, Cinnamon, Garlic, Turmeric, Plant sterol, Red yeast rice).

Period Title: Overall Study
Started 25 25 24 25 25 25 25 25
Completed 24 23 22 24 25 25 24 23
Not Completed 1 2 2 1 0 0 1 2
Reason Not Completed
Lost to Follow-up             1             0             0             0             0             0             0             1
Withdrawal by Subject             0             1             2             1             0             0             0             0
Protocol Violation             0             1             0             0             0             0             0             0
Adverse Event             0             0             0             0             0             0             1             1
Arm/Group Title Rosuvastatin Placebo Fish Oil Cinnamon Garlique Turmeric Plant Sterol Red Yeast Rice Total
Hide Arm/Group Description

5 mg once per day

Rosuvastatin: Subjects will be randomized to a Statin (Rosuvastatin 5 mg), a placebo, or a dietary supplement (Fish oil, Cinnamon, Garlic, Turmeric, Plant sterol, Red yeast rice).

comparable to rosuvastatin 5 mg once per day

Placebo: Subjects will be randomized to a Statin (Rosuvastatin 5 mg), a placebo, or a dietary supplement (Fish oil, Cinnamon, Garlic, Turmeric, Plant sterol, Red yeast rice).

Nature Made 2 soft gels per day

Fish Oil, Cinnamon, Garlique,Turmeric, Plant Sterol, Red Yeast Rice: Subjects will be randomized to a Statin (Rosuvastatin 5 mg), a placebo, or a dietary supplement (Fish oil, Cinnamon, Garlic, Turmeric, Plant sterol, Red yeast rice).

1200mg, 2 capsules per day

Fish Oil, Cinnamon, Garlique,Turmeric, Plant Sterol, Red Yeast Rice: Subjects will be randomized to a Statin (Rosuvastatin 5 mg), a placebo, or a dietary supplement (Fish oil, Cinnamon, Garlic, Turmeric, Plant sterol, Red yeast rice).

Manufactured by Focus Consumer Health Marketgate,1 tablet per day

Fish Oil, Cinnamon, Garlique,Turmeric, Plant Sterol, Red Yeast Rice: Subjects will be randomized to a Statin (Rosuvastatin 5 mg), a placebo, or a dietary supplement (Fish oil, Cinnamon, Garlic, Turmeric, Plant sterol, Red yeast rice).

Bio Schwartz Turmeric Curcumin 1500 mg, 3 capsules per day

Fish Oil, Cinnamon, Garlique,Turmeric, Plant Sterol, Red Yeast Rice: Subjects will be randomized to a Statin (Rosuvastatin 5 mg), a placebo, or a dietary supplement (Fish oil, Cinnamon, Garlic, Turmeric, Plant sterol, Red yeast rice).

Nature Made CholestOff Plus, 2 soft gels twice a day

Fish Oil, Cinnamon, Garlique,Turmeric, Plant Sterol, Red Yeast Rice: Subjects will be randomized to a Statin (Rosuvastatin 5 mg), a placebo, or a dietary supplement (Fish oil, Cinnamon, Garlic, Turmeric, Plant sterol, Red yeast rice).

Arazo Nutrition 1200 mg, 2 capsules per day

Fish Oil, Cinnamon, Garlique,Turmeric, Plant Sterol, Red Yeast Rice: Subjects will be randomized to a Statin (Rosuvastatin 5 mg), a placebo, or a dietary supplement (Fish oil, Cinnamon, Garlic, Turmeric, Plant sterol, Red yeast rice).

Total of all reporting groups
Overall Number of Baseline Participants 25 25 24 25 25 25 25 25 199
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 25 participants 25 participants 24 participants 25 participants 25 participants 25 participants 25 participants 25 participants 199 participants
62.7  (6.02) 63.5  (7.06) 63.9  (6.48) 65.7  (6.57) 65.1  (4.93) 65.1  (7.22) 65.2  (5.30) 64.2  (7.35) 64.4  (6.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants 25 participants 24 participants 25 participants 25 participants 25 participants 25 participants 25 participants 199 participants
Female
14
  56.0%
11
  44.0%
13
  54.2%
15
  60.0%
14
  56.0%
15
  60.0%
18
  72.0%
18
  72.0%
118
  59.3%
Male
11
  44.0%
14
  56.0%
11
  45.8%
10
  40.0%
11
  44.0%
10
  40.0%
7
  28.0%
7
  28.0%
81
  40.7%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants 25 participants 24 participants 25 participants 25 participants 25 participants 25 participants 25 participants 199 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   4.0%
0
   0.0%
0
   0.0%
1
   0.5%
Not Hispanic or Latino
25
 100.0%
25
 100.0%
24
 100.0%
25
 100.0%
25
 100.0%
24
  96.0%
25
 100.0%
25
 100.0%
198
  99.5%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants 25 participants 24 participants 25 participants 25 participants 25 participants 25 participants 25 participants 199 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
1
   4.0%
1
   4.2%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
2
   1.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
3
  12.0%
2
   8.0%
3
  12.5%
2
   8.0%
0
   0.0%
2
   8.0%
2
   8.0%
4
  16.0%
18
   9.0%
White
22
  88.0%
22
  88.0%
20
  83.3%
23
  92.0%
24
  96.0%
22
  88.0%
23
  92.0%
21
  84.0%
177
  88.9%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   4.0%
1
   4.0%
0
   0.0%
0
   0.0%
2
   1.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 25 participants 25 participants 24 participants 25 participants 25 participants 25 participants 25 participants 25 participants 199 participants
25 25 24 25 25 25 25 25 199
1.Primary Outcome
Title Percent Change in LDL-C From Baseline for Rosuvastatin 5mg Daily Compared With Placebo and Each Dietary Supplement.
Hide Description The primary objective of this study is to compare the LDL lowering of rosuvastatin with the effect of six commonly used dietary supplements on cholesterol health.
Time Frame The percent change in LDL-C for rosuvastatin 5 mg compared with dietary supplements after 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Rosuvastatin Placebo Fish Oil Cinnamon Garlique Turmeric Plant Sterol Red Yeast Rice
Hide Arm/Group Description:

5 mg once per day

Rosuvastatin: Subjects will be randomized to a Statin (Rosuvastatin 5 mg), a placebo, or a dietary supplement (Fish oil, Cinnamon, Garlic, Turmeric, Plant sterol, Red yeast rice).

comparable to rosuvastatin 5 mg once per day

Placebo: Subjects will be randomized to a Statin (Rosuvastatin 5 mg), a placebo, or a dietary supplement (Fish oil, Cinnamon, Garlic, Turmeric, Plant sterol, Red yeast rice).

Nature Made 2 soft gels per day

Fish Oil, Cinnamon, Garlique,Turmeric, Plant Sterol, Red Yeast Rice: Subjects will be randomized to a Statin (Rosuvastatin 5 mg), a placebo, or a dietary supplement (Fish oil, Cinnamon, Garlic, Turmeric, Plant sterol, Red yeast rice).

1200mg, 2 capsules per day

Fish Oil, Cinnamon, Garlique,Turmeric, Plant Sterol, Red Yeast Rice: Subjects will be randomized to a Statin (Rosuvastatin 5 mg), a placebo, or a dietary supplement (Fish oil, Cinnamon, Garlic, Turmeric, Plant sterol, Red yeast rice).

Manufactured by Focus Consumer Health Marketgate,1 tablet per day

Fish Oil, Cinnamon, Garlique,Turmeric, Plant Sterol, Red Yeast Rice: Subjects will be randomized to a Statin (Rosuvastatin 5 mg), a placebo, or a dietary supplement (Fish oil, Cinnamon, Garlic, Turmeric, Plant sterol, Red yeast rice).

Bio Schwartz Turmeric Curcumin 1500 mg, 3 capsules per day

Fish Oil, Cinnamon, Garlique,Turmeric, Plant Sterol, Red Yeast Rice: Subjects will be randomized to a Statin (Rosuvastatin 5 mg), a placebo, or a dietary supplement (Fish oil, Cinnamon, Garlic, Turmeric, Plant sterol, Red yeast rice).

Nature Made CholestOff Plus, 2 soft gels twice a day

Fish Oil, Cinnamon, Garlique,Turmeric, Plant Sterol, Red Yeast Rice: Subjects will be randomized to a Statin (Rosuvastatin 5 mg), a placebo, or a dietary supplement (Fish oil, Cinnamon, Garlic, Turmeric, Plant sterol, Red yeast rice).

Arazo Nutrition 1200 mg, 2 capsules per day

Fish Oil, Cinnamon, Garlique,Turmeric, Plant Sterol, Red Yeast Rice: Subjects will be randomized to a Statin (Rosuvastatin 5 mg), a placebo, or a dietary supplement (Fish oil, Cinnamon, Garlic, Turmeric, Plant sterol, Red yeast rice).

Overall Number of Participants Analyzed 24 23 22 24 25 25 24 23
Least Squares Mean (95% Confidence Interval)
Unit of Measure: percent change LDL-C
Percent change from baseline
-37.86
(-42.13 to -33.59)
-2.63
(-6.99 to 1.73)
-3.43
(-7.86 to 1.01)
0.42
(-3.91 to 4.74)
5.13
(0.97 to 9.29)
-1.29
(-5.44 to 2.87)
-4.37
(-8.65 to -0.09)
-6.55
(-10.94 to -2.16)
Difference in Percent Change
0
(0 to 0)
35.22
(29.13 to 41.32)
34.43
(28.28 to 40.58)
38.27
(32.20 to 44.34)
42.98
(37.02 to 48.95)
36.57
(30.61 to 42.54)
33.49
(27.42 to 39.55)
31.31
(25.16 to 37.47)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Rosuvastatin, Placebo
Comments To control the overall alpha of the study, the primary endpoint will be evaluated hierarchically. Each comparison to rosuvastatin will use an alpha of 0.05. This belongs to the primary endpoint.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 35.22
Confidence Interval (2-Sided) 95%
29.13 to 41.32
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Rosuvastatin, Fish Oil
Comments To control the overall alpha of the study, the primary endpoint will be evaluated hierarchically. Each comparison to rosuvastatin will use an alpha of 0.05.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 34.43
Confidence Interval (2-Sided) 95%
28.28 to 40.58
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Rosuvastatin, Cinnamon
Comments To control the overall alpha of the study, the primary endpoint will be evaluated hierarchically. Each comparison to rosuvastatin will use an alpha of 0.05.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 38.27
Confidence Interval (2-Sided) 95%
32.20 to 44.34
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Rosuvastatin, Garlique
Comments To control the overall alpha of the study, the primary endpoint will be evaluated hierarchically. Each comparison to rosuvastatin will use an alpha of 0.05.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 42.98
Confidence Interval (2-Sided) 95%
37.02 to 48.95
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Rosuvastatin, Turmeric
Comments To control the overall alpha of the study, the primary endpoint will be evaluated hierarchically. Each comparison to rosuvastatin will use an alpha of 0.05.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 36.57
Confidence Interval (2-Sided) 95%
30.61 to 42.54
Estimation Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Rosuvastatin, Plant Sterol
Comments To control the overall alpha of the study, the primary endpoint will be evaluated hierarchically. Each comparison to rosuvastatin will use an alpha of 0.05.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 33.49
Confidence Interval (2-Sided) 95%
27.42 to 39.55
Estimation Comments [Not Specified]
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Rosuvastatin, Red Yeast Rice
Comments To control the overall alpha of the study, the primary endpoint will be evaluated hierarchically. Each comparison to rosuvastatin will use an alpha of 0.05.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 31.31
Confidence Interval (2-Sided) 95%
25.16 to 37.47
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Percent Change in hsCRP for Rosuvastatin vs Dietary Supplements.
Hide Description Assess the effect of each supplement on inflammatory markers compared with rosuvastatin 5 mg.
Time Frame The percent change in high sensitivity C reactive protein (hsCRP) for rosuvastatin 5 mg and dietary supplements compared with placebo after 4 weeks.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Rosuvastatin Placebo Fish Oil Cinnamon Garlique Turmeric Plant Sterol Red Yeast Rice
Hide Arm/Group Description:

5 mg once per day

Rosuvastatin: Subjects will be randomized to a Statin (Rosuvastatin 5 mg), a placebo, or a dietary supplement (Fish oil, Cinnamon, Garlic, Turmeric, Plant sterol, Red yeast rice).

comparable to rosuvastatin 5 mg once per day

Placebo: Subjects will be randomized to a Statin (Rosuvastatin 5 mg), a placebo, or a dietary supplement (Fish oil, Cinnamon, Garlic, Turmeric, Plant sterol, Red yeast rice).

Nature Made 2 soft gels per day

Fish Oil, Cinnamon, Garlique,Turmeric, Plant Sterol, Red Yeast Rice: Subjects will be randomized to a Statin (Rosuvastatin 5 mg), a placebo, or a dietary supplement (Fish oil, Cinnamon, Garlic, Turmeric, Plant sterol, Red yeast rice).

1200mg, 2 capsules per day

Fish Oil, Cinnamon, Garlique,Turmeric, Plant Sterol, Red Yeast Rice: Subjects will be randomized to a Statin (Rosuvastatin 5 mg), a placebo, or a dietary supplement (Fish oil, Cinnamon, Garlic, Turmeric, Plant sterol, Red yeast rice).

Manufactured by Focus Consumer Health Marketgate,1 tablet per day

Fish Oil, Cinnamon, Garlique,Turmeric, Plant Sterol, Red Yeast Rice: Subjects will be randomized to a Statin (Rosuvastatin 5 mg), a placebo, or a dietary supplement (Fish oil, Cinnamon, Garlic, Turmeric, Plant sterol, Red yeast rice).

Bio Schwartz Turmeric Curcumin 1500 mg, 3 capsules per day

Fish Oil, Cinnamon, Garlique,Turmeric, Plant Sterol, Red Yeast Rice: Subjects will be randomized to a Statin (Rosuvastatin 5 mg), a placebo, or a dietary supplement (Fish oil, Cinnamon, Garlic, Turmeric, Plant sterol, Red yeast rice).

Nature Made CholestOff Plus, 2 soft gels twice a day

Fish Oil, Cinnamon, Garlique,Turmeric, Plant Sterol, Red Yeast Rice: Subjects will be randomized to a Statin (Rosuvastatin 5 mg), a placebo, or a dietary supplement (Fish oil, Cinnamon, Garlic, Turmeric, Plant sterol, Red yeast rice).

Arazo Nutrition 1200 mg, 2 capsules per day

Fish Oil, Cinnamon, Garlique,Turmeric, Plant Sterol, Red Yeast Rice: Subjects will be randomized to a Statin (Rosuvastatin 5 mg), a placebo, or a dietary supplement (Fish oil, Cinnamon, Garlic, Turmeric, Plant sterol, Red yeast rice).

Overall Number of Participants Analyzed 24 23 22 24 25 25 24 23
Least Squares Mean (95% Confidence Interval)
Unit of Measure: percent change hsCRP
percentage change from baseline
-5.70
(-32.52 to 31.78)
-7.12
(-34.06 to 30.83)
-1.39
(-30.45 to 39.81)
29.04
(-7.94 to 80.88)
1.09
(-27.08 to 40.14)
-4.49
(-31.08 to 32.36)
-13.72
(-38.28 to 20.60)
6.28
(-24.42 to 49.43)
Difference in percent change
0
(0 to 0)
-1.50
(-38.92 to 58.86)
4.58
(-35.47 to 69.47)
36.85
(-15.07 to 120.52)
7.20
(-32.90 to 71.28)
1.29
(-36.59 to 61.79)
-8.50
(-43.05 to 46.99)
12.71
(-30.14 to 81.83)
3.Secondary Outcome
Title Percent Change in HDL-C, Total Cholesterol, and Triglycerides for Rosuvastatin vs Dietary Supplements.
Hide Description

The percent change in HDL-C, total cholesterol, and triglycerides for each supplement compared with rosuvastatin.

The percent change in HDL-C, total cholesterol, and triglycerides for each supplement compared with rosuvastatin. The percent change in HDL-C, total cholesterol, and triglycerides for each supplement compared with placebo.

Time Frame After 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Rosuvastatin Placebo Fish Oil Cinnamon Garlique Turmeric Plant Sterol Red Yeast Rice
Hide Arm/Group Description:
Rosuvastatin 5 mg once per day
Comparable to 5mg Rosuvastatin once per day
Nature Made 2 soft gels per day
1200mg, 2 capsules per day
1 tablet per day
Bio Schwartz Curcumin, 1500mg, 3 capsules per day
Nature Made CHolestOff Plus, 2 soft gels 2 times per day
Arazo Nutrition, Red Yeast Rice, 1200mg, 2 capsules per day
Overall Number of Participants Analyzed 24 23 22 24 25 25 24 23
Least Squares Mean (95% Confidence Interval)
Unit of Measure: % change HDLC,Tot Cholest, Triglycerides
Percent change from baseline HDL-C
3.44
(-0.73 to 7.62)
3.08
(-1.16 to 7.32)
2.41
(-1.91 to 6.73)
-2.33
(-6.47 to 1.80)
3.43
(-0.61 to 7.47)
1.42
(-2.62 to 5.45)
-4.02
(-8.16 to 0.13)
2.45
(-1.79 to 6.69)
Difference in percentage change HDL-C
0
(0 to 0)
-0.37
(-6.34 to 5.60)
-1.03
(-7.07 to 5.01)
-5.78
(-11.71 to 0.16)
-0.02
(-5.86 to 5.83)
-2.03
(-7.83 to 3.78)
-7.46
(-13.34 to -1.58)
-0.99
(-6.91 to 4.92)
Percent change from baseline Total Cholesterol
-24.43
(-27.57 to -21.29)
-1.44
(-4.65 to 1.77)
-2.23
(-5.50 to 1.04)
0.37
(-2.78 to 3.52)
2.80
(-0.26 to 5.86)
-0.75
(-3.80 to 2.30)
-3.89
(-7.02 to -0.75)
-2.60
(-5.80 to 0.60)
Difference in percent change Total Cholesterol
0
(0 to 0)
22.99
(18.49 to 27.48)
22.20
(17.65 to 26.74)
24.80
(20.36 to 29.23)
27.23
(22.85 to 31.61)
23.68
(19.30 to 28.06)
20.54
(16.08 to 25.00)
21.83
(17.33 to 26.33)
Percent change from baseline Triglycerides
-19.25
(-27.60 to -9.94)
-1.41
(-11.78 to 10.18)
-5.01
(-15.19 to 6.40)
8.34
(-2.80 to 20.75)
-5.43
(-15.03 to 5.26)
0.26
(-9.82 to 11.47)
1.28
(-9.17 to 12.93)
4.11
(-6.81 to 16.31)
Difference in percent change Triglycerides
0
(0 to 0)
22.09
(4.52 to 42.62)
17.64
(0.58 to 37.58)
34.16
(14.94 to 56.60)
17.11
(0.41 to 36.60)
24.16
(6.61 to 44.60)
25.42
(7.49 to 46.35)
28.93
(10.36 to 50.63)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Rosuvastatin
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.05
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
4.Secondary Outcome
Title The Percent Change in HDL-C, Total Cholesterol, and Triglycerides for Placebo vs the Dietary Supplements.
Hide Description The percent change in HDL-C, total cholesterol, and triglycerides for each supplement compared with placebo.
Time Frame After 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Rosuvastatin Placebo Fish Oil Cinnamon Garlique Turmeric Plant Sterol Red Yeast Rice
Hide Arm/Group Description:

5 mg once per day

Rosuvastatin: Subjects will be randomized to a Statin (Rosuvastatin 5 mg), a placebo, or a dietary supplement (Fish oil, Cinnamon, Garlic, Turmeric, Plant sterol, Red yeast rice).

comparable to rosuvastatin 5 mg once per day

Placebo: Subjects will be randomized to a Statin (Rosuvastatin 5 mg), a placebo, or a dietary supplement (Fish oil, Cinnamon, Garlic, Turmeric, Plant sterol, Red yeast rice).

Nature Made 2 soft gels per day

Fish Oil, Cinnamon, Garlique,Turmeric, Plant Sterol, Red Yeast Rice: Subjects will be randomized to a Statin (Rosuvastatin 5 mg), a placebo, or a dietary supplement (Fish oil, Cinnamon, Garlic, Turmeric, Plant sterol, Red yeast rice).

1200mg, 2 capsules per day

Fish Oil, Cinnamon, Garlique,Turmeric, Plant Sterol, Red Yeast Rice: Subjects will be randomized to a Statin (Rosuvastatin 5 mg), a placebo, or a dietary supplement (Fish oil, Cinnamon, Garlic, Turmeric, Plant sterol, Red yeast rice).

Manufactured by Focus Consumer Health Marketgate,1 tablet per day

Fish Oil, Cinnamon, Garlique,Turmeric, Plant Sterol, Red Yeast Rice: Subjects will be randomized to a Statin (Rosuvastatin 5 mg), a placebo, or a dietary supplement (Fish oil, Cinnamon, Garlic, Turmeric, Plant sterol, Red yeast rice).

Bio Schwartz Turmeric Curcumin 1500 mg, 3 capsules per day

Fish Oil, Cinnamon, Garlique,Turmeric, Plant Sterol, Red Yeast Rice: Subjects will be randomized to a Statin (Rosuvastatin 5 mg), a placebo, or a dietary supplement (Fish oil, Cinnamon, Garlic, Turmeric, Plant sterol, Red yeast rice).

Nature Made CholestOff Plus, 2 soft gels twice a day

Fish Oil, Cinnamon, Garlique,Turmeric, Plant Sterol, Red Yeast Rice: Subjects will be randomized to a Statin (Rosuvastatin 5 mg), a placebo, or a dietary supplement (Fish oil, Cinnamon, Garlic, Turmeric, Plant sterol, Red yeast rice).

Arazo Nutrition 1200 mg, 2 capsules per day

Fish Oil, Cinnamon, Garlique,Turmeric, Plant Sterol, Red Yeast Rice: Subjects will be randomized to a Statin (Rosuvastatin 5 mg), a placebo, or a dietary supplement (Fish oil, Cinnamon, Garlic, Turmeric, Plant sterol, Red yeast rice).

Overall Number of Participants Analyzed 24 23 22 24 25 25 24 23
Least Squares Mean (95% Confidence Interval)
Unit of Measure: % change HDLC, tot chole, triglycerides
Percent change from baseline HDL-C
3.44
(-0.73 to 7.62)
3.08
(-1.16 to 7.32)
2.41
(-1.91 to 6.73)
-2.33
(-6.47 to 1.80)
3.43
(-0.61 to 7.47)
1.42
(-2.62 to 5.45)
-4.02
(-8.16 to 0.13)
2.45
(-1.79 to 6.69)
Difference in percent change HDL-C
0.37
(-5.60 to 6.34)
0
(0 to 0)
-0.67
(-6.68 to 5.35)
-5.41
(-11.31 to 0.49)
0.35
(-5.49 to 6.19)
-1.66
(-7.52 to 4.20)
-7.09
(-13.07 to -1.12)
-0.63
(-6.67 to 5.42)
Percent change from baseline total cholesterol
-24.43
(-27.57 to -21.29)
-1.44
(-4.65 to 1.77)
-2.23
(-5.50 to 1.04)
0.37
(-2.78 to 3.52)
2.80
(-0.26 to 5.86)
-0.75
(-3.80 to 2.30)
-3.89
(-7.02 to -0.75)
-2.60
(-5.80 to 0.60)
Difference in percent change total cholesterol
-22.99
(-27.48 to -18.49)
0
(0 to 0)
-0.79
(-5.34 to 3.76)
1.81
(-2.71 to 6.33)
4.24
(-0.19 to 8.68)
0.69
(-3.75 to 5.13)
-2.45
(-6.95 to 2.06)
-1.16
(-5.69 to 3.37)
Percent change from baseline triglycerides
-19.25
(-27.60 to -9.94)
-1.41
(-11.78 to 10.18)
-5.01
(-15.19 to 6.40)
8.34
(-2.80 to 20.75)
-5.43
(-15.03 to 5.26)
0.26
(-9.82 to 11.47)
1.28
(-9.17 to 12.93)
4.11
(-6.81 to 16.31)
Difference in percent change triglycerides
-18.09
(-29.88 to -4.32)
0
(0 to 0)
-3.65
(-17.77 to 12.90)
9.88
(-5.92 to 28.34)
-4.08
(-17.78 to 11.91)
1.69
(-12.79 to 18.58)
2.73
(-12.16 to 20.14)
5.60
(-9.79 to 23.63)
Time Frame 4 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Rosuvastatin Placebo Fish Oil Cinnamon Garlique Turmeric Plant Sterol Red Yeast Rice
Hide Arm/Group Description

5 mg once per day

Rosuvastatin: Subjects will be randomized to a Statin (Rosuvastatin 5 mg), a placebo, or a dietary supplement (Fish oil, Cinnamon, Garlic, Turmeric, Plant sterol, Red yeast rice).

comparable to rosuvastatin 5 mg once per day

Placebo: Subjects will be randomized to a Statin (Rosuvastatin 5 mg), a placebo, or a dietary supplement (Fish oil, Cinnamon, Garlic, Turmeric, Plant sterol, Red yeast rice).

Nature Made 2 soft gels per day

Fish Oil, Cinnamon, Garlique,Turmeric, Plant Sterol, Red Yeast Rice: Subjects will be randomized to a Statin (Rosuvastatin 5 mg), a placebo, or a dietary supplement (Fish oil, Cinnamon, Garlic, Turmeric, Plant sterol, Red yeast rice).

1200mg, 2 capsules per day

Fish Oil, Cinnamon, Garlique,Turmeric, Plant Sterol, Red Yeast Rice: Subjects will be randomized to a Statin (Rosuvastatin 5 mg), a placebo, or a dietary supplement (Fish oil, Cinnamon, Garlic, Turmeric, Plant sterol, Red yeast rice).

Manufactured by Focus Consumer Health Marketgate,1 tablet per day

Fish Oil, Cinnamon, Garlique,Turmeric, Plant Sterol, Red Yeast Rice: Subjects will be randomized to a Statin (Rosuvastatin 5 mg), a placebo, or a dietary supplement (Fish oil, Cinnamon, Garlic, Turmeric, Plant sterol, Red yeast rice).

Bio Schwartz Turmeric Curcumin 1500 mg, 3 capsules per day

Fish Oil, Cinnamon, Garlique,Turmeric, Plant Sterol, Red Yeast Rice: Subjects will be randomized to a Statin (Rosuvastatin 5 mg), a placebo, or a dietary supplement (Fish oil, Cinnamon, Garlic, Turmeric, Plant sterol, Red yeast rice).

Nature Made CholestOff Plus, 2 soft gels twice a day

Fish Oil, Cinnamon, Garlique,Turmeric, Plant Sterol, Red Yeast Rice: Subjects will be randomized to a Statin (Rosuvastatin 5 mg), a placebo, or a dietary supplement (Fish oil, Cinnamon, Garlic, Turmeric, Plant sterol, Red yeast rice).

Arazo Nutrition 1200 mg, 2 capsules per day

Fish Oil, Cinnamon, Garlique,Turmeric, Plant Sterol, Red Yeast Rice: Subjects will be randomized to a Statin (Rosuvastatin 5 mg), a placebo, or a dietary supplement (Fish oil, Cinnamon, Garlic, Turmeric, Plant sterol, Red yeast rice).

All-Cause Mortality
Rosuvastatin Placebo Fish Oil Cinnamon Garlique Turmeric Plant Sterol Red Yeast Rice
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/25 (0.00%)      0/25 (0.00%)      0/24 (0.00%)      0/25 (0.00%)      0/25 (0.00%)      0/25 (0.00%)      0/25 (0.00%)      0/25 (0.00%)    
Hide Serious Adverse Events
Rosuvastatin Placebo Fish Oil Cinnamon Garlique Turmeric Plant Sterol Red Yeast Rice
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/25 (0.00%)      1/25 (4.00%)      1/24 (4.17%)      0/25 (0.00%)      0/25 (0.00%)      0/25 (0.00%)      0/25 (0.00%)      0/25 (0.00%)    
Gastrointestinal disorders                 
Clinical Change in Liver Function   0/25 (0.00%)  0 0/25 (0.00%)  0 1/24 (4.17%)  1 0/25 (0.00%)  0 0/25 (0.00%)  0 0/25 (0.00%)  0 0/25 (0.00%)  0 0/25 (0.00%)  0
Vascular disorders                 
Deep Vein Thrombosis   /25  1/25 (4.00%)  1 0/24 (0.00%)  0 0/25 (0.00%)  0 0/25 (0.00%)  0 0/25 (0.00%)  0 0/25 (0.00%)  0 0/25 (0.00%)  0
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Rosuvastatin Placebo Fish Oil Cinnamon Garlique Turmeric Plant Sterol Red Yeast Rice
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/25 (0.00%)      3/25 (12.00%)      1/24 (4.17%)      0/25 (0.00%)      2/25 (8.00%)      1/25 (4.00%)      2/25 (8.00%)      5/25 (20.00%)    
Musculoskeletal and connective tissue disorders                 
Muscle Pain / Tenderness   0/25 (0.00%)  0 2/25 (8.00%)  2 0/24 (0.00%)  0 0/25 (0.00%)  0 1/25 (4.00%)  1 1/25 (4.00%)  1 1/25 (4.00%)  1 2/25 (8.00%)  2
Nervous system disorders                 
Headache   0/25 (0.00%)  0 1/25 (4.00%)  1 1/24 (4.17%)  1 0/25 (0.00%)  0 1/25 (4.00%)  1 0/25 (0.00%)  0 1/25 (4.00%)  1 3/25 (12.00%)  3
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Luke Laffin, MD
Organization: Cleveland Clinic
Phone: 216-372-4315
EMail: Laffinl@ccf.org
Layout table for additonal information
Responsible Party: The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT04846231    
Other Study ID Numbers: Version 1.0 23February2021
First Submitted: April 12, 2021
First Posted: April 15, 2021
Results First Submitted: April 18, 2023
Results First Posted: May 25, 2023
Last Update Posted: May 25, 2023