Trial Outcomes & Findings for Supplements, Placebo, or Rosuvastatin Study (NCT NCT04846231)
NCT ID: NCT04846231
Last Updated: 2023-05-25
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
203 participants
Primary outcome timeframe
The percent change in LDL-C for rosuvastatin 5 mg compared with dietary supplements after 4 weeks
Results posted on
2023-05-25
Participant Flow
203 subjects were enrolled and 199 randomized.
Participant milestones
| Measure |
Rosuvastatin
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).
|
Placebo
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).
|
Fish Oil
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).
|
Cinnamon
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).
|
Garlique
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).
|
Turmeric
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).
|
Plant Sterol
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).
|
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 Study
STARTED
|
25
|
25
|
24
|
25
|
25
|
25
|
25
|
25
|
|
Overall Study
COMPLETED
|
24
|
23
|
22
|
24
|
25
|
25
|
24
|
23
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
2
|
1
|
0
|
0
|
1
|
2
|
Reasons for withdrawal
| Measure |
Rosuvastatin
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).
|
Placebo
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).
|
Fish Oil
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).
|
Cinnamon
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).
|
Garlique
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).
|
Turmeric
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).
|
Plant Sterol
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).
|
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 Study
Lost to Follow-up
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
2
|
1
|
0
|
0
|
0
|
0
|
|
Overall Study
Protocol Violation
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
1
|
Baseline Characteristics
Supplements, Placebo, or Rosuvastatin Study
Baseline characteristics by cohort
| Measure |
Rosuvastatin
n=25 Participants
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).
|
Placebo
n=25 Participants
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).
|
Fish Oil
n=24 Participants
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).
|
Cinnamon
n=25 Participants
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).
|
Garlique
n=25 Participants
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).
|
Turmeric
n=25 Participants
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).
|
Plant Sterol
n=25 Participants
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).
|
Red Yeast Rice
n=25 Participants
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
n=199 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
62.7 years
STANDARD_DEVIATION 6.02 • n=5 Participants
|
63.5 years
STANDARD_DEVIATION 7.06 • n=7 Participants
|
63.9 years
STANDARD_DEVIATION 6.48 • n=5 Participants
|
65.7 years
STANDARD_DEVIATION 6.57 • n=4 Participants
|
65.1 years
STANDARD_DEVIATION 4.93 • n=21 Participants
|
65.1 years
STANDARD_DEVIATION 7.22 • n=10 Participants
|
65.2 years
STANDARD_DEVIATION 5.30 • n=115 Participants
|
64.2 years
STANDARD_DEVIATION 7.35 • n=24 Participants
|
64.4 years
STANDARD_DEVIATION 6.4 • n=42 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
14 Participants
n=21 Participants
|
15 Participants
n=10 Participants
|
18 Participants
n=115 Participants
|
18 Participants
n=24 Participants
|
118 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
10 Participants
n=10 Participants
|
7 Participants
n=115 Participants
|
7 Participants
n=24 Participants
|
81 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
25 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
25 Participants
n=4 Participants
|
25 Participants
n=21 Participants
|
24 Participants
n=10 Participants
|
25 Participants
n=115 Participants
|
25 Participants
n=24 Participants
|
198 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
2 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
4 Participants
n=24 Participants
|
18 Participants
n=42 Participants
|
|
Race (NIH/OMB)
White
|
22 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
23 Participants
n=4 Participants
|
24 Participants
n=21 Participants
|
22 Participants
n=10 Participants
|
23 Participants
n=115 Participants
|
21 Participants
n=24 Participants
|
177 Participants
n=42 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
2 Participants
n=42 Participants
|
|
Region of Enrollment
United States
|
25 participants
n=5 Participants
|
25 participants
n=7 Participants
|
24 participants
n=5 Participants
|
25 participants
n=4 Participants
|
25 participants
n=21 Participants
|
25 participants
n=10 Participants
|
25 participants
n=115 Participants
|
25 participants
n=24 Participants
|
199 participants
n=42 Participants
|
PRIMARY outcome
Timeframe: The percent change in LDL-C for rosuvastatin 5 mg compared with dietary supplements after 4 weeksThe 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.
Outcome measures
| Measure |
Rosuvastatin
n=24 Participants
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).
|
Placebo
n=23 Participants
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).
|
Fish Oil
n=22 Participants
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).
|
Cinnamon
n=24 Participants
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).
|
Garlique
n=25 Participants
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).
|
Turmeric
n=25 Participants
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).
|
Plant Sterol
n=24 Participants
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).
|
Red Yeast Rice
n=23 Participants
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).
|
|---|---|---|---|---|---|---|---|---|
|
Percent Change in LDL-C From Baseline for Rosuvastatin 5mg Daily Compared With Placebo and Each Dietary Supplement.
Percent change from baseline
|
-37.86 percent change LDL-C
Interval -42.13 to -33.59
|
-2.63 percent change LDL-C
Interval -6.99 to 1.73
|
-3.43 percent change LDL-C
Interval -7.86 to 1.01
|
0.42 percent change LDL-C
Interval -3.91 to 4.74
|
5.13 percent change LDL-C
Interval 0.97 to 9.29
|
-1.29 percent change LDL-C
Interval -5.44 to 2.87
|
-4.37 percent change LDL-C
Interval -8.65 to -0.09
|
-6.55 percent change LDL-C
Interval -10.94 to -2.16
|
|
Percent Change in LDL-C From Baseline for Rosuvastatin 5mg Daily Compared With Placebo and Each Dietary Supplement.
Difference in Percent Change
|
0 percent change LDL-C
Interval 0.0 to 0.0
|
35.22 percent change LDL-C
Interval 29.13 to 41.32
|
34.43 percent change LDL-C
Interval 28.28 to 40.58
|
38.27 percent change LDL-C
Interval 32.2 to 44.34
|
42.98 percent change LDL-C
Interval 37.02 to 48.95
|
36.57 percent change LDL-C
Interval 30.61 to 42.54
|
33.49 percent change LDL-C
Interval 27.42 to 39.55
|
31.31 percent change LDL-C
Interval 25.16 to 37.47
|
SECONDARY outcome
Timeframe: The percent change in high sensitivity C reactive protein (hsCRP) for rosuvastatin 5 mg and dietary supplements compared with placebo after 4 weeks.Assess the effect of each supplement on inflammatory markers compared with rosuvastatin 5 mg.
Outcome measures
| Measure |
Rosuvastatin
n=24 Participants
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).
|
Placebo
n=23 Participants
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).
|
Fish Oil
n=22 Participants
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).
|
Cinnamon
n=24 Participants
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).
|
Garlique
n=25 Participants
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).
|
Turmeric
n=25 Participants
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).
|
Plant Sterol
n=24 Participants
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).
|
Red Yeast Rice
n=23 Participants
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).
|
|---|---|---|---|---|---|---|---|---|
|
Percent Change in hsCRP for Rosuvastatin vs Dietary Supplements.
percentage change from baseline
|
-5.70 percent change hsCRP
Interval -32.52 to 31.78
|
-7.12 percent change hsCRP
Interval -34.06 to 30.83
|
-1.39 percent change hsCRP
Interval -30.45 to 39.81
|
29.04 percent change hsCRP
Interval -7.94 to 80.88
|
1.09 percent change hsCRP
Interval -27.08 to 40.14
|
-4.49 percent change hsCRP
Interval -31.08 to 32.36
|
-13.72 percent change hsCRP
Interval -38.28 to 20.6
|
6.28 percent change hsCRP
Interval -24.42 to 49.43
|
|
Percent Change in hsCRP for Rosuvastatin vs Dietary Supplements.
Difference in percent change
|
0 percent change hsCRP
Interval 0.0 to 0.0
|
-1.50 percent change hsCRP
Interval -38.92 to 58.86
|
4.58 percent change hsCRP
Interval -35.47 to 69.47
|
36.85 percent change hsCRP
Interval -15.07 to 120.52
|
7.20 percent change hsCRP
Interval -32.9 to 71.28
|
1.29 percent change hsCRP
Interval -36.59 to 61.79
|
-8.50 percent change hsCRP
Interval -43.05 to 46.99
|
12.71 percent change hsCRP
Interval -30.14 to 81.83
|
SECONDARY outcome
Timeframe: After 4 weeksThe 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.
Outcome measures
| Measure |
Rosuvastatin
n=24 Participants
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).
|
Placebo
n=23 Participants
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).
|
Fish Oil
n=22 Participants
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).
|
Cinnamon
n=24 Participants
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).
|
Garlique
n=25 Participants
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).
|
Turmeric
n=25 Participants
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).
|
Plant Sterol
n=24 Participants
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).
|
Red Yeast Rice
n=23 Participants
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).
|
|---|---|---|---|---|---|---|---|---|
|
Percent Change in HDL-C, Total Cholesterol, and Triglycerides for Rosuvastatin vs Dietary Supplements.
Percent change from baseline HDL-C
|
3.44 % change HDLC,Tot Cholest, Triglycerides
Interval -0.73 to 7.62
|
3.08 % change HDLC,Tot Cholest, Triglycerides
Interval -1.16 to 7.32
|
2.41 % change HDLC,Tot Cholest, Triglycerides
Interval -1.91 to 6.73
|
-2.33 % change HDLC,Tot Cholest, Triglycerides
Interval -6.47 to 1.8
|
3.43 % change HDLC,Tot Cholest, Triglycerides
Interval -0.61 to 7.47
|
1.42 % change HDLC,Tot Cholest, Triglycerides
Interval -2.62 to 5.45
|
-4.02 % change HDLC,Tot Cholest, Triglycerides
Interval -8.16 to 0.13
|
2.45 % change HDLC,Tot Cholest, Triglycerides
Interval -1.79 to 6.69
|
|
Percent Change in HDL-C, Total Cholesterol, and Triglycerides for Rosuvastatin vs Dietary Supplements.
Difference in percentage change HDL-C
|
0 % change HDLC,Tot Cholest, Triglycerides
Interval 0.0 to 0.0
|
-0.37 % change HDLC,Tot Cholest, Triglycerides
Interval -6.34 to 5.6
|
-1.03 % change HDLC,Tot Cholest, Triglycerides
Interval -7.07 to 5.01
|
-5.78 % change HDLC,Tot Cholest, Triglycerides
Interval -11.71 to 0.16
|
-0.02 % change HDLC,Tot Cholest, Triglycerides
Interval -5.86 to 5.83
|
-2.03 % change HDLC,Tot Cholest, Triglycerides
Interval -7.83 to 3.78
|
-7.46 % change HDLC,Tot Cholest, Triglycerides
Interval -13.34 to -1.58
|
-0.99 % change HDLC,Tot Cholest, Triglycerides
Interval -6.91 to 4.92
|
|
Percent Change in HDL-C, Total Cholesterol, and Triglycerides for Rosuvastatin vs Dietary Supplements.
Percent change from baseline Total Cholesterol
|
-24.43 % change HDLC,Tot Cholest, Triglycerides
Interval -27.57 to -21.29
|
-1.44 % change HDLC,Tot Cholest, Triglycerides
Interval -4.65 to 1.77
|
-2.23 % change HDLC,Tot Cholest, Triglycerides
Interval -5.5 to 1.04
|
0.37 % change HDLC,Tot Cholest, Triglycerides
Interval -2.78 to 3.52
|
2.80 % change HDLC,Tot Cholest, Triglycerides
Interval -0.26 to 5.86
|
-0.75 % change HDLC,Tot Cholest, Triglycerides
Interval -3.8 to 2.3
|
-3.89 % change HDLC,Tot Cholest, Triglycerides
Interval -7.02 to -0.75
|
-2.60 % change HDLC,Tot Cholest, Triglycerides
Interval -5.8 to 0.6
|
|
Percent Change in HDL-C, Total Cholesterol, and Triglycerides for Rosuvastatin vs Dietary Supplements.
Difference in percent change Total Cholesterol
|
0 % change HDLC,Tot Cholest, Triglycerides
Interval 0.0 to 0.0
|
22.99 % change HDLC,Tot Cholest, Triglycerides
Interval 18.49 to 27.48
|
22.20 % change HDLC,Tot Cholest, Triglycerides
Interval 17.65 to 26.74
|
24.80 % change HDLC,Tot Cholest, Triglycerides
Interval 20.36 to 29.23
|
27.23 % change HDLC,Tot Cholest, Triglycerides
Interval 22.85 to 31.61
|
23.68 % change HDLC,Tot Cholest, Triglycerides
Interval 19.3 to 28.06
|
20.54 % change HDLC,Tot Cholest, Triglycerides
Interval 16.08 to 25.0
|
21.83 % change HDLC,Tot Cholest, Triglycerides
Interval 17.33 to 26.33
|
|
Percent Change in HDL-C, Total Cholesterol, and Triglycerides for Rosuvastatin vs Dietary Supplements.
Percent change from baseline Triglycerides
|
-19.25 % change HDLC,Tot Cholest, Triglycerides
Interval -27.6 to -9.94
|
-1.41 % change HDLC,Tot Cholest, Triglycerides
Interval -11.78 to 10.18
|
-5.01 % change HDLC,Tot Cholest, Triglycerides
Interval -15.19 to 6.4
|
8.34 % change HDLC,Tot Cholest, Triglycerides
Interval -2.8 to 20.75
|
-5.43 % change HDLC,Tot Cholest, Triglycerides
Interval -15.03 to 5.26
|
0.26 % change HDLC,Tot Cholest, Triglycerides
Interval -9.82 to 11.47
|
1.28 % change HDLC,Tot Cholest, Triglycerides
Interval -9.17 to 12.93
|
4.11 % change HDLC,Tot Cholest, Triglycerides
Interval -6.81 to 16.31
|
|
Percent Change in HDL-C, Total Cholesterol, and Triglycerides for Rosuvastatin vs Dietary Supplements.
Difference in percent change Triglycerides
|
0 % change HDLC,Tot Cholest, Triglycerides
Interval 0.0 to 0.0
|
22.09 % change HDLC,Tot Cholest, Triglycerides
Interval 4.52 to 42.62
|
17.64 % change HDLC,Tot Cholest, Triglycerides
Interval 0.58 to 37.58
|
34.16 % change HDLC,Tot Cholest, Triglycerides
Interval 14.94 to 56.6
|
17.11 % change HDLC,Tot Cholest, Triglycerides
Interval 0.41 to 36.6
|
24.16 % change HDLC,Tot Cholest, Triglycerides
Interval 6.61 to 44.6
|
25.42 % change HDLC,Tot Cholest, Triglycerides
Interval 7.49 to 46.35
|
28.93 % change HDLC,Tot Cholest, Triglycerides
Interval 10.36 to 50.63
|
SECONDARY outcome
Timeframe: After 4 weeksThe percent change in HDL-C, total cholesterol, and triglycerides for each supplement compared with placebo.
Outcome measures
| Measure |
Rosuvastatin
n=24 Participants
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).
|
Placebo
n=23 Participants
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).
|
Fish Oil
n=22 Participants
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).
|
Cinnamon
n=24 Participants
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).
|
Garlique
n=25 Participants
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).
|
Turmeric
n=25 Participants
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).
|
Plant Sterol
n=24 Participants
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).
|
Red Yeast Rice
n=23 Participants
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).
|
|---|---|---|---|---|---|---|---|---|
|
The Percent Change in HDL-C, Total Cholesterol, and Triglycerides for Placebo vs the Dietary Supplements.
Percent change from baseline HDL-C
|
3.44 % change HDLC, tot chole, triglycerides
Interval -0.73 to 7.62
|
3.08 % change HDLC, tot chole, triglycerides
Interval -1.16 to 7.32
|
2.41 % change HDLC, tot chole, triglycerides
Interval -1.91 to 6.73
|
-2.33 % change HDLC, tot chole, triglycerides
Interval -6.47 to 1.8
|
3.43 % change HDLC, tot chole, triglycerides
Interval -0.61 to 7.47
|
1.42 % change HDLC, tot chole, triglycerides
Interval -2.62 to 5.45
|
-4.02 % change HDLC, tot chole, triglycerides
Interval -8.16 to 0.13
|
2.45 % change HDLC, tot chole, triglycerides
Interval -1.79 to 6.69
|
|
The Percent Change in HDL-C, Total Cholesterol, and Triglycerides for Placebo vs the Dietary Supplements.
Difference in percent change HDL-C
|
0.37 % change HDLC, tot chole, triglycerides
Interval -5.6 to 6.34
|
0 % change HDLC, tot chole, triglycerides
Interval 0.0 to 0.0
|
-0.67 % change HDLC, tot chole, triglycerides
Interval -6.68 to 5.35
|
-5.41 % change HDLC, tot chole, triglycerides
Interval -11.31 to 0.49
|
0.35 % change HDLC, tot chole, triglycerides
Interval -5.49 to 6.19
|
-1.66 % change HDLC, tot chole, triglycerides
Interval -7.52 to 4.2
|
-7.09 % change HDLC, tot chole, triglycerides
Interval -13.07 to -1.12
|
-0.63 % change HDLC, tot chole, triglycerides
Interval -6.67 to 5.42
|
|
The Percent Change in HDL-C, Total Cholesterol, and Triglycerides for Placebo vs the Dietary Supplements.
Percent change from baseline total cholesterol
|
-24.43 % change HDLC, tot chole, triglycerides
Interval -27.57 to -21.29
|
-1.44 % change HDLC, tot chole, triglycerides
Interval -4.65 to 1.77
|
-2.23 % change HDLC, tot chole, triglycerides
Interval -5.5 to 1.04
|
0.37 % change HDLC, tot chole, triglycerides
Interval -2.78 to 3.52
|
2.80 % change HDLC, tot chole, triglycerides
Interval -0.26 to 5.86
|
-0.75 % change HDLC, tot chole, triglycerides
Interval -3.8 to 2.3
|
-3.89 % change HDLC, tot chole, triglycerides
Interval -7.02 to -0.75
|
-2.60 % change HDLC, tot chole, triglycerides
Interval -5.8 to 0.6
|
|
The Percent Change in HDL-C, Total Cholesterol, and Triglycerides for Placebo vs the Dietary Supplements.
Difference in percent change total cholesterol
|
-22.99 % change HDLC, tot chole, triglycerides
Interval -27.48 to -18.49
|
0 % change HDLC, tot chole, triglycerides
Interval 0.0 to 0.0
|
-0.79 % change HDLC, tot chole, triglycerides
Interval -5.34 to 3.76
|
1.81 % change HDLC, tot chole, triglycerides
Interval -2.71 to 6.33
|
4.24 % change HDLC, tot chole, triglycerides
Interval -0.19 to 8.68
|
0.69 % change HDLC, tot chole, triglycerides
Interval -3.75 to 5.13
|
-2.45 % change HDLC, tot chole, triglycerides
Interval -6.95 to 2.06
|
-1.16 % change HDLC, tot chole, triglycerides
Interval -5.69 to 3.37
|
|
The Percent Change in HDL-C, Total Cholesterol, and Triglycerides for Placebo vs the Dietary Supplements.
Percent change from baseline triglycerides
|
-19.25 % change HDLC, tot chole, triglycerides
Interval -27.6 to -9.94
|
-1.41 % change HDLC, tot chole, triglycerides
Interval -11.78 to 10.18
|
-5.01 % change HDLC, tot chole, triglycerides
Interval -15.19 to 6.4
|
8.34 % change HDLC, tot chole, triglycerides
Interval -2.8 to 20.75
|
-5.43 % change HDLC, tot chole, triglycerides
Interval -15.03 to 5.26
|
0.26 % change HDLC, tot chole, triglycerides
Interval -9.82 to 11.47
|
1.28 % change HDLC, tot chole, triglycerides
Interval -9.17 to 12.93
|
4.11 % change HDLC, tot chole, triglycerides
Interval -6.81 to 16.31
|
|
The Percent Change in HDL-C, Total Cholesterol, and Triglycerides for Placebo vs the Dietary Supplements.
Difference in percent change triglycerides
|
-18.09 % change HDLC, tot chole, triglycerides
Interval -29.88 to -4.32
|
0 % change HDLC, tot chole, triglycerides
Interval 0.0 to 0.0
|
-3.65 % change HDLC, tot chole, triglycerides
Interval -17.77 to 12.9
|
9.88 % change HDLC, tot chole, triglycerides
Interval -5.92 to 28.34
|
-4.08 % change HDLC, tot chole, triglycerides
Interval -17.78 to 11.91
|
1.69 % change HDLC, tot chole, triglycerides
Interval -12.79 to 18.58
|
2.73 % change HDLC, tot chole, triglycerides
Interval -12.16 to 20.14
|
5.60 % change HDLC, tot chole, triglycerides
Interval -9.79 to 23.63
|
Adverse Events
Rosuvastatin
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Fish Oil
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Cinnamon
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Garlique
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Turmeric
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Plant Sterol
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Red Yeast Rice
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Rosuvastatin
n=25 participants at risk
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).
|
Placebo
n=25 participants at risk
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).
|
Fish Oil
n=24 participants at risk
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).
|
Cinnamon
n=25 participants at risk
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).
|
Garlique
n=25 participants at risk
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).
|
Turmeric
n=25 participants at risk
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).
|
Plant Sterol
n=25 participants at risk
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).
|
Red Yeast Rice
n=25 participants at risk
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).
|
|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Clinical Change in Liver Function
|
0.00%
0/25 • 4 weeks
|
0.00%
0/25 • 4 weeks
|
4.2%
1/24 • Number of events 1 • 4 weeks
|
0.00%
0/25 • 4 weeks
|
0.00%
0/25 • 4 weeks
|
0.00%
0/25 • 4 weeks
|
0.00%
0/25 • 4 weeks
|
0.00%
0/25 • 4 weeks
|
|
Vascular disorders
Deep Vein Thrombosis
|
0.00%
0/25 • 4 weeks
|
4.0%
1/25 • Number of events 1 • 4 weeks
|
0.00%
0/24 • 4 weeks
|
0.00%
0/25 • 4 weeks
|
0.00%
0/25 • 4 weeks
|
0.00%
0/25 • 4 weeks
|
0.00%
0/25 • 4 weeks
|
0.00%
0/25 • 4 weeks
|
Other adverse events
| Measure |
Rosuvastatin
n=25 participants at risk
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).
|
Placebo
n=25 participants at risk
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).
|
Fish Oil
n=24 participants at risk
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).
|
Cinnamon
n=25 participants at risk
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).
|
Garlique
n=25 participants at risk
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).
|
Turmeric
n=25 participants at risk
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).
|
Plant Sterol
n=25 participants at risk
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).
|
Red Yeast Rice
n=25 participants at risk
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).
|
|---|---|---|---|---|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Muscle Pain / Tenderness
|
0.00%
0/25 • 4 weeks
|
8.0%
2/25 • Number of events 2 • 4 weeks
|
0.00%
0/24 • 4 weeks
|
0.00%
0/25 • 4 weeks
|
4.0%
1/25 • Number of events 1 • 4 weeks
|
4.0%
1/25 • Number of events 1 • 4 weeks
|
4.0%
1/25 • Number of events 1 • 4 weeks
|
8.0%
2/25 • Number of events 2 • 4 weeks
|
|
Nervous system disorders
Headache
|
0.00%
0/25 • 4 weeks
|
4.0%
1/25 • Number of events 1 • 4 weeks
|
4.2%
1/24 • Number of events 1 • 4 weeks
|
0.00%
0/25 • 4 weeks
|
4.0%
1/25 • Number of events 1 • 4 weeks
|
0.00%
0/25 • 4 weeks
|
4.0%
1/25 • Number of events 1 • 4 weeks
|
12.0%
3/25 • Number of events 3 • 4 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place