Hypercholesterolemia
Conditions
Keywords
LDL & HDL Cholesterol, Statin, Dietary Supplements
Brief summary
A research study that is evaluating a low dose of an FDA approved statin medication in comparison to several commercially available over the counter dietary supplements which are marketed for cholesterol health. The study is comparing their effect on LDL cholesterol. LDL-cholesterol is low-density cholesterol and is sometimes referred to as bad cholesterol. Participants must live in Ohio and have a documented elevated LDL cholesterol level between 70-189mg/dL, must not currently be taking a statin or one of the dietary supplements included in the trial. Participants willing to discontinue a prohibited supplement for 4 weeks prior to enrollment will be allowed to participate. Trial participation is 4 weeks. Study medication will be provided at no charge. There will be 2 visits which include a lab draw at any Cleveland Clinic laboratory. Participants will be randomized (like a coin flip) to be in one of 8 possible groups: Rosuvastatin, Fish oil, Cinnamon, Garlic, Turmeric, Plant sterol, Red yeast rice, or placebo. The study will enroll 200 participants.
Detailed description
Few well-controlled trials have studied the LDL-lowering effects of dozens of marketed cholesterol health dietary supplements. Prior research suggests most U.S. consumers believe cholesterol health supplements are safer than statins, and a majority of the public also believe supplements are as effective, or more effective, than prescription statins. Approximately one third of US adults who have been told they have elevated cholesterol are using a supplement to provide heart health protection rather than a statin. This represents a significant public health concern. The purpose of this study is to evaluate the effect of select dietary supplements on cholesterol health compared with a low dose of a statin. The study is comparing their effect on LDL and HDL cholesterol and inflammatory markers. A randomized, single blind study design will be used to evaluate rosuvastatin 5 mg. vs. placebo and 6 commercially available over the counter supplements in a hierarchical testing order. Each participant will take study medication/supplement for a total of 4 weeks. The study will randomize primary prevention patients who are considered borderline and intermediate risk for ASCVD based upon the 2018 Cholesterol Treatment Guidelines7 and are not taking any of the studied medication/supplements at the time of randomization. Participants must have a documented elevated LDL cholesterol level between 70-189mg/dL, must not currently be taking a statin or one of the dietary supplements included in the trial. Participants willing to discontinue a prohibited supplement for 4 weeks prior to enrollment will be allowed to participate. Study medication will be provided at no charge. There will be 2 visits which include a lab draw at any Cleveland Clinic laboratory. Participants will be randomized (like a coin flip) to be in one of 8 possible groups: Rosuvastatin, Fish oil, Cinnamon, Garlic, Turmeric, Plant sterol, Red yeast rice, or placebo. The study will enroll 200 participants.
Interventions
DIETARY_SUPPLEMENTFish 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).
DRUGRosuvastatin
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).
OTHERPlacebo
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).
Sponsors
AstraZeneca
The Cleveland Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
Subjects, investigator staff, persons performing the assessments, and the clinical trial team will be blinded to assigned study group.
Intervention model description
Eligible subjects will be randomized 1:1:1:1:1:1:1:1 to the study groups in a blinded fashion. There will be 25 subjects per study group. The total sample size will be 200 patients.
Eligibility
Sex/Gender
ALL
Age
40 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Written informed consent must be obtained before any assessment is performed. 2. U.S. adults with primary hypercholesterolemia, 40-75 years of age. 3. Not currently taking statins or one of the dietary supplements included in the trial. Patients willing to discontinue a prohibited supplement for 4 weeks prior to enrollment will be allowed to participate. 4. LDL-cholesterol between 70 and 189 mg/dL. 5. Patients without diabetes mellitus and a 10-year risk of ASCVD between 5 and \<20% using the pooled cohort risk equation. \* Or Patients with diabetes mellitus in females 50-60 years of age or males 40-50 years of age with an LDL-C between 70-189 mg/dL and with an ASCVD risk below 20%.
Exclusion criteria
1. Age \< 40 or \>75 years of age 2. Women who are pregnant, plan to become pregnant within the next 6 months, or are breastfeeding. 3. Documented liver dysfunction or history of elevated LFTs indicating active liver disease 4. Documented chronic renal dysfunction within the past two years defined as an eGFR\<30mL/min/m2. 5. Known hypersensitivity to rosuvastatin or any supplement under investigation (i.e. shellfish allergy, etc.). 6. Currently taking any prescription statin, or other prescription medication/supplements to treat elevated cholesterol or triglycerides. 7. Currently taking a medication/supplement that has known interaction with rosuvastatin, including fenofibrate, gemfibrozil, HIV medications, colchicine, cyclosporine, warfarin, anti-viral medications to treat Hepatitis C, regorafenib, and darolutamide. 8. Are unwilling to discontinue prohibited dietary supplement(s) for 4 weeks prior to participation or during the course of the trial. Other non-prohibited supplements will be permitted if doses have been stable for at least 4 weeks. 9. Known cardiovascular disease including a history of prior MI, stroke/TIA, PAD or prior revascularization procedures of the heart or vasculature (e.g. CABG, stenting, PCI etc.). 10. Fasting Triglycerides \>200mg/dl. 11. In the opinion of the investigator, any other condition that will preclude participation in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change in LDL-C From Baseline for Rosuvastatin 5mg Daily Compared With Placebo and Each Dietary Supplement. | The percent change in LDL-C for rosuvastatin 5 mg compared with dietary supplements after 4 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change in hsCRP for Rosuvastatin vs Dietary Supplements. | 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. |
| Percent Change in HDL-C, Total Cholesterol, and Triglycerides for Rosuvastatin vs Dietary Supplements. | After 4 weeks | 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. |
| The Percent Change in HDL-C, Total Cholesterol, and Triglycerides for Placebo vs the Dietary Supplements. | After 4 weeks | The percent change in HDL-C, total cholesterol, and triglycerides for each supplement compared with placebo. |
Countries
United States
Participant flow
Pre-assignment details
203 subjects were enrolled and 199 randomized.
Participants by arm
| Arm | Count |
|---|---|
| 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). | 25 |
| 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). | 25 |
| 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). | 24 |
| 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). | 25 |
| 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). | 25 |
| 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). | 25 |
| 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). | 25 |
| 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). | 25 |
| Total | 199 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 |
|---|---|---|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 1 |
| Overall Study | Lost to Follow-up | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
| Overall Study | Protocol Violation | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 0 | 1 | 2 | 1 | 0 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | Rosuvastatin | Total | Red Yeast Rice | Plant Sterol | Turmeric | Garlique | Cinnamon | Fish Oil | Placebo |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 62.7 years STANDARD_DEVIATION 6.02 | 64.4 years STANDARD_DEVIATION 6.4 | 64.2 years STANDARD_DEVIATION 7.35 | 65.2 years STANDARD_DEVIATION 5.3 | 65.1 years STANDARD_DEVIATION 7.22 | 65.1 years STANDARD_DEVIATION 4.93 | 65.7 years STANDARD_DEVIATION 6.57 | 63.9 years STANDARD_DEVIATION 6.48 | 63.5 years STANDARD_DEVIATION 7.06 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 25 Participants | 198 Participants | 25 Participants | 25 Participants | 24 Participants | 25 Participants | 25 Participants | 24 Participants | 25 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 2 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 18 Participants | 4 Participants | 2 Participants | 2 Participants | 0 Participants | 2 Participants | 3 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 2 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 22 Participants | 177 Participants | 21 Participants | 23 Participants | 22 Participants | 24 Participants | 23 Participants | 20 Participants | 22 Participants |
| Region of Enrollment United States | 25 participants | 199 participants | 25 participants | 25 participants | 25 participants | 25 participants | 25 participants | 24 participants | 25 participants |
| Sex: Female, Male Female | 14 Participants | 118 Participants | 18 Participants | 18 Participants | 15 Participants | 14 Participants | 15 Participants | 13 Participants | 11 Participants |
| Sex: Female, Male Male | 11 Participants | 81 Participants | 7 Participants | 7 Participants | 10 Participants | 11 Participants | 10 Participants | 11 Participants | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk |
|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 25 | 0 / 25 | 0 / 24 | 0 / 25 | 0 / 25 | 0 / 25 | 0 / 25 | 0 / 25 |
| other Total, other adverse events | 0 / 25 | 3 / 25 | 1 / 24 | 0 / 25 | 2 / 25 | 1 / 25 | 2 / 25 | 5 / 25 |
| serious Total, serious adverse events | 0 / 25 | 1 / 25 | 1 / 24 | 0 / 25 | 0 / 25 | 0 / 25 | 0 / 25 | 0 / 25 |
Outcome results
Primary
Percent Change in LDL-C From Baseline for Rosuvastatin 5mg Daily Compared With Placebo and Each Dietary Supplement.
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
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Rosuvastatin | 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 |
| Rosuvastatin | 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 |
| Placebo | Percent Change in LDL-C From Baseline for Rosuvastatin 5mg Daily Compared With Placebo and Each Dietary Supplement. | Percent change from baseline | -2.63 percent change LDL-C |
| Placebo | Percent Change in LDL-C From Baseline for Rosuvastatin 5mg Daily Compared With Placebo and Each Dietary Supplement. | Difference in Percent Change | 35.22 percent change LDL-C |
| Fish Oil | Percent Change in LDL-C From Baseline for Rosuvastatin 5mg Daily Compared With Placebo and Each Dietary Supplement. | Percent change from baseline | -3.43 percent change LDL-C |
| Fish Oil | Percent Change in LDL-C From Baseline for Rosuvastatin 5mg Daily Compared With Placebo and Each Dietary Supplement. | Difference in Percent Change | 34.43 percent change LDL-C |
| Cinnamon | Percent Change in LDL-C From Baseline for Rosuvastatin 5mg Daily Compared With Placebo and Each Dietary Supplement. | Percent change from baseline | 0.42 percent change LDL-C |
| Cinnamon | Percent Change in LDL-C From Baseline for Rosuvastatin 5mg Daily Compared With Placebo and Each Dietary Supplement. | Difference in Percent Change | 38.27 percent change LDL-C |
| Garlique | Percent Change in LDL-C From Baseline for Rosuvastatin 5mg Daily Compared With Placebo and Each Dietary Supplement. | Percent change from baseline | 5.13 percent change LDL-C |
| Garlique | Percent Change in LDL-C From Baseline for Rosuvastatin 5mg Daily Compared With Placebo and Each Dietary Supplement. | Difference in Percent Change | 42.98 percent change LDL-C |
| Turmeric | Percent Change in LDL-C From Baseline for Rosuvastatin 5mg Daily Compared With Placebo and Each Dietary Supplement. | Percent change from baseline | -1.29 percent change LDL-C |
| Turmeric | Percent Change in LDL-C From Baseline for Rosuvastatin 5mg Daily Compared With Placebo and Each Dietary Supplement. | Difference in Percent Change | 36.57 percent change LDL-C |
| Plant Sterol | Percent Change in LDL-C From Baseline for Rosuvastatin 5mg Daily Compared With Placebo and Each Dietary Supplement. | Difference in Percent Change | 33.49 percent change LDL-C |
| Plant Sterol | Percent Change in LDL-C From Baseline for Rosuvastatin 5mg Daily Compared With Placebo and Each Dietary Supplement. | Percent change from baseline | -4.37 percent change LDL-C |
| 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 | -6.55 percent change LDL-C |
| Red Yeast Rice | Percent Change in LDL-C From Baseline for Rosuvastatin 5mg Daily Compared With Placebo and Each Dietary Supplement. | Difference in Percent Change | 31.31 percent change LDL-C |
Comparison: 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.p-value: <0.00195% CI: [29.13, 41.32]ANCOVA
Comparison: 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.p-value: <0.00195% CI: [28.28, 40.58]ANCOVA
Comparison: 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.p-value: <0.00195% CI: [32.2, 44.34]ANCOVA
Comparison: 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.p-value: <0.00195% CI: [37.02, 48.95]ANCOVA
Comparison: 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.p-value: <0.00195% CI: [30.61, 42.54]ANCOVA
Comparison: 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.p-value: <0.00195% CI: [27.42, 39.55]ANCOVA
Comparison: 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.p-value: <0.00195% CI: [25.16, 37.47]ANCOVA
Secondary
Percent Change in HDL-C, Total Cholesterol, and Triglycerides for Rosuvastatin vs Dietary Supplements.
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
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Rosuvastatin | 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 |
| Rosuvastatin | 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 |
| Rosuvastatin | 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 |
| Rosuvastatin | 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 |
| Rosuvastatin | 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 |
| Rosuvastatin | 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 |
| Placebo | Percent Change in HDL-C, Total Cholesterol, and Triglycerides for Rosuvastatin vs Dietary Supplements. | Difference in percentage change HDL-C | -0.37 % change HDLC,Tot Cholest, Triglycerides |
| Placebo | Percent Change in HDL-C, Total Cholesterol, and Triglycerides for Rosuvastatin vs Dietary Supplements. | Percent change from baseline Total Cholesterol | -1.44 % change HDLC,Tot Cholest, Triglycerides |
| Placebo | Percent Change in HDL-C, Total Cholesterol, and Triglycerides for Rosuvastatin vs Dietary Supplements. | Percent change from baseline HDL-C | 3.08 % change HDLC,Tot Cholest, Triglycerides |
| Placebo | Percent Change in HDL-C, Total Cholesterol, and Triglycerides for Rosuvastatin vs Dietary Supplements. | Difference in percent change Triglycerides | 22.09 % change HDLC,Tot Cholest, Triglycerides |
| Placebo | Percent Change in HDL-C, Total Cholesterol, and Triglycerides for Rosuvastatin vs Dietary Supplements. | Percent change from baseline Triglycerides | -1.41 % change HDLC,Tot Cholest, Triglycerides |
| Placebo | Percent Change in HDL-C, Total Cholesterol, and Triglycerides for Rosuvastatin vs Dietary Supplements. | Difference in percent change Total Cholesterol | 22.99 % change HDLC,Tot Cholest, Triglycerides |
| Fish Oil | Percent Change in HDL-C, Total Cholesterol, and Triglycerides for Rosuvastatin vs Dietary Supplements. | Difference in percent change Total Cholesterol | 22.20 % change HDLC,Tot Cholest, Triglycerides |
| Fish Oil | Percent Change in HDL-C, Total Cholesterol, and Triglycerides for Rosuvastatin vs Dietary Supplements. | Percent change from baseline HDL-C | 2.41 % change HDLC,Tot Cholest, Triglycerides |
| Fish Oil | Percent Change in HDL-C, Total Cholesterol, and Triglycerides for Rosuvastatin vs Dietary Supplements. | Difference in percentage change HDL-C | -1.03 % change HDLC,Tot Cholest, Triglycerides |
| Fish Oil | Percent Change in HDL-C, Total Cholesterol, and Triglycerides for Rosuvastatin vs Dietary Supplements. | Percent change from baseline Total Cholesterol | -2.23 % change HDLC,Tot Cholest, Triglycerides |
| Fish Oil | Percent Change in HDL-C, Total Cholesterol, and Triglycerides for Rosuvastatin vs Dietary Supplements. | Percent change from baseline Triglycerides | -5.01 % change HDLC,Tot Cholest, Triglycerides |
| Fish Oil | Percent Change in HDL-C, Total Cholesterol, and Triglycerides for Rosuvastatin vs Dietary Supplements. | Difference in percent change Triglycerides | 17.64 % change HDLC,Tot Cholest, Triglycerides |
| Cinnamon | Percent Change in HDL-C, Total Cholesterol, and Triglycerides for Rosuvastatin vs Dietary Supplements. | Difference in percent change Triglycerides | 34.16 % change HDLC,Tot Cholest, Triglycerides |
| Cinnamon | Percent Change in HDL-C, Total Cholesterol, and Triglycerides for Rosuvastatin vs Dietary Supplements. | Percent change from baseline HDL-C | -2.33 % change HDLC,Tot Cholest, Triglycerides |
| Cinnamon | Percent Change in HDL-C, Total Cholesterol, and Triglycerides for Rosuvastatin vs Dietary Supplements. | Percent change from baseline Total Cholesterol | 0.37 % change HDLC,Tot Cholest, Triglycerides |
| Cinnamon | Percent Change in HDL-C, Total Cholesterol, and Triglycerides for Rosuvastatin vs Dietary Supplements. | Percent change from baseline Triglycerides | 8.34 % change HDLC,Tot Cholest, Triglycerides |
| Cinnamon | Percent Change in HDL-C, Total Cholesterol, and Triglycerides for Rosuvastatin vs Dietary Supplements. | Difference in percent change Total Cholesterol | 24.80 % change HDLC,Tot Cholest, Triglycerides |
| Cinnamon | Percent Change in HDL-C, Total Cholesterol, and Triglycerides for Rosuvastatin vs Dietary Supplements. | Difference in percentage change HDL-C | -5.78 % change HDLC,Tot Cholest, Triglycerides |
| Garlique | Percent Change in HDL-C, Total Cholesterol, and Triglycerides for Rosuvastatin vs Dietary Supplements. | Difference in percent change Total Cholesterol | 27.23 % change HDLC,Tot Cholest, Triglycerides |
| Garlique | Percent Change in HDL-C, Total Cholesterol, and Triglycerides for Rosuvastatin vs Dietary Supplements. | Percent change from baseline HDL-C | 3.43 % change HDLC,Tot Cholest, Triglycerides |
| Garlique | Percent Change in HDL-C, Total Cholesterol, and Triglycerides for Rosuvastatin vs Dietary Supplements. | Difference in percentage change HDL-C | -0.02 % change HDLC,Tot Cholest, Triglycerides |
| Garlique | Percent Change in HDL-C, Total Cholesterol, and Triglycerides for Rosuvastatin vs Dietary Supplements. | Percent change from baseline Total Cholesterol | 2.80 % change HDLC,Tot Cholest, Triglycerides |
| Garlique | Percent Change in HDL-C, Total Cholesterol, and Triglycerides for Rosuvastatin vs Dietary Supplements. | Percent change from baseline Triglycerides | -5.43 % change HDLC,Tot Cholest, Triglycerides |
| Garlique | Percent Change in HDL-C, Total Cholesterol, and Triglycerides for Rosuvastatin vs Dietary Supplements. | Difference in percent change Triglycerides | 17.11 % change HDLC,Tot Cholest, Triglycerides |
| Turmeric | Percent Change in HDL-C, Total Cholesterol, and Triglycerides for Rosuvastatin vs Dietary Supplements. | Percent change from baseline HDL-C | 1.42 % change HDLC,Tot Cholest, Triglycerides |
| Turmeric | Percent Change in HDL-C, Total Cholesterol, and Triglycerides for Rosuvastatin vs Dietary Supplements. | Percent change from baseline Total Cholesterol | -0.75 % change HDLC,Tot Cholest, Triglycerides |
| Turmeric | Percent Change in HDL-C, Total Cholesterol, and Triglycerides for Rosuvastatin vs Dietary Supplements. | Difference in percent change Total Cholesterol | 23.68 % change HDLC,Tot Cholest, Triglycerides |
| Turmeric | Percent Change in HDL-C, Total Cholesterol, and Triglycerides for Rosuvastatin vs Dietary Supplements. | Difference in percent change Triglycerides | 24.16 % change HDLC,Tot Cholest, Triglycerides |
| Turmeric | Percent Change in HDL-C, Total Cholesterol, and Triglycerides for Rosuvastatin vs Dietary Supplements. | Percent change from baseline Triglycerides | 0.26 % change HDLC,Tot Cholest, Triglycerides |
| Turmeric | Percent Change in HDL-C, Total Cholesterol, and Triglycerides for Rosuvastatin vs Dietary Supplements. | Difference in percentage change HDL-C | -2.03 % change HDLC,Tot Cholest, Triglycerides |
| Plant Sterol | Percent Change in HDL-C, Total Cholesterol, and Triglycerides for Rosuvastatin vs Dietary Supplements. | Difference in percentage change HDL-C | -7.46 % change HDLC,Tot Cholest, Triglycerides |
| Plant Sterol | Percent Change in HDL-C, Total Cholesterol, and Triglycerides for Rosuvastatin vs Dietary Supplements. | Difference in percent change Triglycerides | 25.42 % change HDLC,Tot Cholest, Triglycerides |
| Plant Sterol | Percent Change in HDL-C, Total Cholesterol, and Triglycerides for Rosuvastatin vs Dietary Supplements. | Percent change from baseline Total Cholesterol | -3.89 % change HDLC,Tot Cholest, Triglycerides |
| Plant Sterol | Percent Change in HDL-C, Total Cholesterol, and Triglycerides for Rosuvastatin vs Dietary Supplements. | Percent change from baseline Triglycerides | 1.28 % change HDLC,Tot Cholest, Triglycerides |
| Plant Sterol | Percent Change in HDL-C, Total Cholesterol, and Triglycerides for Rosuvastatin vs Dietary Supplements. | Difference in percent change Total Cholesterol | 20.54 % change HDLC,Tot Cholest, Triglycerides |
| Plant Sterol | Percent Change in HDL-C, Total Cholesterol, and Triglycerides for Rosuvastatin vs Dietary Supplements. | Percent change from baseline HDL-C | -4.02 % change HDLC,Tot Cholest, Triglycerides |
| Red Yeast Rice | Percent Change in HDL-C, Total Cholesterol, and Triglycerides for Rosuvastatin vs Dietary Supplements. | Difference in percentage change HDL-C | -0.99 % change HDLC,Tot Cholest, Triglycerides |
| Red Yeast Rice | Percent Change in HDL-C, Total Cholesterol, and Triglycerides for Rosuvastatin vs Dietary Supplements. | Percent change from baseline HDL-C | 2.45 % change HDLC,Tot Cholest, Triglycerides |
| Red Yeast Rice | Percent Change in HDL-C, Total Cholesterol, and Triglycerides for Rosuvastatin vs Dietary Supplements. | Percent change from baseline Triglycerides | 4.11 % change HDLC,Tot Cholest, Triglycerides |
| Red Yeast Rice | Percent Change in HDL-C, Total Cholesterol, and Triglycerides for Rosuvastatin vs Dietary Supplements. | Percent change from baseline Total Cholesterol | -2.60 % change HDLC,Tot Cholest, Triglycerides |
| Red Yeast Rice | Percent Change in HDL-C, Total Cholesterol, and Triglycerides for Rosuvastatin vs Dietary Supplements. | Difference in percent change Triglycerides | 28.93 % change HDLC,Tot Cholest, Triglycerides |
| Red Yeast Rice | Percent Change in HDL-C, Total Cholesterol, and Triglycerides for Rosuvastatin vs Dietary Supplements. | Difference in percent change Total Cholesterol | 21.83 % change HDLC,Tot Cholest, Triglycerides |
p-value: 0.05ANCOVA
Secondary
Percent Change in hsCRP for Rosuvastatin vs Dietary Supplements.
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.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Rosuvastatin | Percent Change in hsCRP for Rosuvastatin vs Dietary Supplements. | percentage change from baseline | -5.70 percent change hsCRP |
| Rosuvastatin | Percent Change in hsCRP for Rosuvastatin vs Dietary Supplements. | Difference in percent change | 0 percent change hsCRP |
| Placebo | Percent Change in hsCRP for Rosuvastatin vs Dietary Supplements. | percentage change from baseline | -7.12 percent change hsCRP |
| Placebo | Percent Change in hsCRP for Rosuvastatin vs Dietary Supplements. | Difference in percent change | -1.50 percent change hsCRP |
| Fish Oil | Percent Change in hsCRP for Rosuvastatin vs Dietary Supplements. | percentage change from baseline | -1.39 percent change hsCRP |
| Fish Oil | Percent Change in hsCRP for Rosuvastatin vs Dietary Supplements. | Difference in percent change | 4.58 percent change hsCRP |
| Cinnamon | Percent Change in hsCRP for Rosuvastatin vs Dietary Supplements. | percentage change from baseline | 29.04 percent change hsCRP |
| Cinnamon | Percent Change in hsCRP for Rosuvastatin vs Dietary Supplements. | Difference in percent change | 36.85 percent change hsCRP |
| Garlique | Percent Change in hsCRP for Rosuvastatin vs Dietary Supplements. | percentage change from baseline | 1.09 percent change hsCRP |
| Garlique | Percent Change in hsCRP for Rosuvastatin vs Dietary Supplements. | Difference in percent change | 7.20 percent change hsCRP |
| Turmeric | Percent Change in hsCRP for Rosuvastatin vs Dietary Supplements. | percentage change from baseline | -4.49 percent change hsCRP |
| Turmeric | Percent Change in hsCRP for Rosuvastatin vs Dietary Supplements. | Difference in percent change | 1.29 percent change hsCRP |
| Plant Sterol | Percent Change in hsCRP for Rosuvastatin vs Dietary Supplements. | Difference in percent change | -8.50 percent change hsCRP |
| Plant Sterol | Percent Change in hsCRP for Rosuvastatin vs Dietary Supplements. | percentage change from baseline | -13.72 percent change hsCRP |
| Red Yeast Rice | Percent Change in hsCRP for Rosuvastatin vs Dietary Supplements. | percentage change from baseline | 6.28 percent change hsCRP |
| Red Yeast Rice | Percent Change in hsCRP for Rosuvastatin vs Dietary Supplements. | Difference in percent change | 12.71 percent change hsCRP |
Secondary
The Percent Change in HDL-C, Total Cholesterol, and Triglycerides for Placebo vs the Dietary Supplements.
The percent change in HDL-C, total cholesterol, and triglycerides for each supplement compared with placebo.
Time frame: After 4 weeks
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Rosuvastatin | 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 |
| Rosuvastatin | 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 |
| Rosuvastatin | 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 |
| Rosuvastatin | 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 |
| Rosuvastatin | 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 |
| Rosuvastatin | 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 |
| Placebo | The Percent Change in HDL-C, Total Cholesterol, and Triglycerides for Placebo vs the Dietary Supplements. | Percent change from baseline triglycerides | -1.41 % change HDLC, tot chole, triglycerides |
| Placebo | The Percent Change in HDL-C, Total Cholesterol, and Triglycerides for Placebo vs the Dietary Supplements. | Percent change from baseline total cholesterol | -1.44 % change HDLC, tot chole, triglycerides |
| Placebo | The Percent Change in HDL-C, Total Cholesterol, and Triglycerides for Placebo vs the Dietary Supplements. | Percent change from baseline HDL-C | 3.08 % change HDLC, tot chole, triglycerides |
| Placebo | The Percent Change in HDL-C, Total Cholesterol, and Triglycerides for Placebo vs the Dietary Supplements. | Difference in percent change triglycerides | 0 % change HDLC, tot chole, triglycerides |
| Placebo | The Percent Change in HDL-C, Total Cholesterol, and Triglycerides for Placebo vs the Dietary Supplements. | Difference in percent change HDL-C | 0 % change HDLC, tot chole, triglycerides |
| Placebo | The Percent Change in HDL-C, Total Cholesterol, and Triglycerides for Placebo vs the Dietary Supplements. | Difference in percent change total cholesterol | 0 % change HDLC, tot chole, triglycerides |
| Fish Oil | The Percent Change in HDL-C, Total Cholesterol, and Triglycerides for Placebo vs the Dietary Supplements. | Difference in percent change HDL-C | -0.67 % change HDLC, tot chole, triglycerides |
| Fish Oil | The Percent Change in HDL-C, Total Cholesterol, and Triglycerides for Placebo vs the Dietary Supplements. | Percent change from baseline total cholesterol | -2.23 % change HDLC, tot chole, triglycerides |
| Fish Oil | The Percent Change in HDL-C, Total Cholesterol, and Triglycerides for Placebo vs the Dietary Supplements. | Percent change from baseline HDL-C | 2.41 % change HDLC, tot chole, triglycerides |
| Fish Oil | The Percent Change in HDL-C, Total Cholesterol, and Triglycerides for Placebo vs the Dietary Supplements. | Difference in percent change total cholesterol | -0.79 % change HDLC, tot chole, triglycerides |
| Fish Oil | The Percent Change in HDL-C, Total Cholesterol, and Triglycerides for Placebo vs the Dietary Supplements. | Percent change from baseline triglycerides | -5.01 % change HDLC, tot chole, triglycerides |
| Fish Oil | The Percent Change in HDL-C, Total Cholesterol, and Triglycerides for Placebo vs the Dietary Supplements. | Difference in percent change triglycerides | -3.65 % change HDLC, tot chole, triglycerides |
| Cinnamon | The Percent Change in HDL-C, Total Cholesterol, and Triglycerides for Placebo vs the Dietary Supplements. | Percent change from baseline HDL-C | -2.33 % change HDLC, tot chole, triglycerides |
| Cinnamon | The Percent Change in HDL-C, Total Cholesterol, and Triglycerides for Placebo vs the Dietary Supplements. | Difference in percent change HDL-C | -5.41 % change HDLC, tot chole, triglycerides |
| Cinnamon | The Percent Change in HDL-C, Total Cholesterol, and Triglycerides for Placebo vs the Dietary Supplements. | Percent change from baseline total cholesterol | 0.37 % change HDLC, tot chole, triglycerides |
| Cinnamon | The Percent Change in HDL-C, Total Cholesterol, and Triglycerides for Placebo vs the Dietary Supplements. | Difference in percent change total cholesterol | 1.81 % change HDLC, tot chole, triglycerides |
| Cinnamon | The Percent Change in HDL-C, Total Cholesterol, and Triglycerides for Placebo vs the Dietary Supplements. | Percent change from baseline triglycerides | 8.34 % change HDLC, tot chole, triglycerides |
| Cinnamon | The Percent Change in HDL-C, Total Cholesterol, and Triglycerides for Placebo vs the Dietary Supplements. | Difference in percent change triglycerides | 9.88 % change HDLC, tot chole, triglycerides |
| Garlique | The Percent Change in HDL-C, Total Cholesterol, and Triglycerides for Placebo vs the Dietary Supplements. | Difference in percent change total cholesterol | 4.24 % change HDLC, tot chole, triglycerides |
| Garlique | The Percent Change in HDL-C, Total Cholesterol, and Triglycerides for Placebo vs the Dietary Supplements. | Percent change from baseline HDL-C | 3.43 % change HDLC, tot chole, triglycerides |
| Garlique | The Percent Change in HDL-C, Total Cholesterol, and Triglycerides for Placebo vs the Dietary Supplements. | Percent change from baseline total cholesterol | 2.80 % change HDLC, tot chole, triglycerides |
| Garlique | The Percent Change in HDL-C, Total Cholesterol, and Triglycerides for Placebo vs the Dietary Supplements. | Difference in percent change HDL-C | 0.35 % change HDLC, tot chole, triglycerides |
| Garlique | The Percent Change in HDL-C, Total Cholesterol, and Triglycerides for Placebo vs the Dietary Supplements. | Difference in percent change triglycerides | -4.08 % change HDLC, tot chole, triglycerides |
| Garlique | The Percent Change in HDL-C, Total Cholesterol, and Triglycerides for Placebo vs the Dietary Supplements. | Percent change from baseline triglycerides | -5.43 % change HDLC, tot chole, triglycerides |
| Turmeric | The Percent Change in HDL-C, Total Cholesterol, and Triglycerides for Placebo vs the Dietary Supplements. | Difference in percent change HDL-C | -1.66 % change HDLC, tot chole, triglycerides |
| Turmeric | The Percent Change in HDL-C, Total Cholesterol, and Triglycerides for Placebo vs the Dietary Supplements. | Percent change from baseline triglycerides | 0.26 % change HDLC, tot chole, triglycerides |
| Turmeric | The Percent Change in HDL-C, Total Cholesterol, and Triglycerides for Placebo vs the Dietary Supplements. | Percent change from baseline HDL-C | 1.42 % change HDLC, tot chole, triglycerides |
| Turmeric | The Percent Change in HDL-C, Total Cholesterol, and Triglycerides for Placebo vs the Dietary Supplements. | Difference in percent change total cholesterol | 0.69 % change HDLC, tot chole, triglycerides |
| Turmeric | The Percent Change in HDL-C, Total Cholesterol, and Triglycerides for Placebo vs the Dietary Supplements. | Percent change from baseline total cholesterol | -0.75 % change HDLC, tot chole, triglycerides |
| Turmeric | The Percent Change in HDL-C, Total Cholesterol, and Triglycerides for Placebo vs the Dietary Supplements. | Difference in percent change triglycerides | 1.69 % change HDLC, tot chole, triglycerides |
| Plant Sterol | The Percent Change in HDL-C, Total Cholesterol, and Triglycerides for Placebo vs the Dietary Supplements. | Difference in percent change triglycerides | 2.73 % change HDLC, tot chole, triglycerides |
| Plant Sterol | The Percent Change in HDL-C, Total Cholesterol, and Triglycerides for Placebo vs the Dietary Supplements. | Difference in percent change HDL-C | -7.09 % change HDLC, tot chole, triglycerides |
| Plant Sterol | The Percent Change in HDL-C, Total Cholesterol, and Triglycerides for Placebo vs the Dietary Supplements. | Difference in percent change total cholesterol | -2.45 % change HDLC, tot chole, triglycerides |
| Plant Sterol | The Percent Change in HDL-C, Total Cholesterol, and Triglycerides for Placebo vs the Dietary Supplements. | Percent change from baseline HDL-C | -4.02 % change HDLC, tot chole, triglycerides |
| Plant Sterol | The Percent Change in HDL-C, Total Cholesterol, and Triglycerides for Placebo vs the Dietary Supplements. | Percent change from baseline total cholesterol | -3.89 % change HDLC, tot chole, triglycerides |
| Plant Sterol | The Percent Change in HDL-C, Total Cholesterol, and Triglycerides for Placebo vs the Dietary Supplements. | Percent change from baseline triglycerides | 1.28 % change HDLC, tot chole, triglycerides |
| Red Yeast Rice | The Percent Change in HDL-C, Total Cholesterol, and Triglycerides for Placebo vs the Dietary Supplements. | Percent change from baseline triglycerides | 4.11 % change HDLC, tot chole, triglycerides |
| 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 | 2.45 % change HDLC, tot chole, triglycerides |
| Red Yeast Rice | The Percent Change in HDL-C, Total Cholesterol, and Triglycerides for Placebo vs the Dietary Supplements. | Difference in percent change HDL-C | -0.63 % change HDLC, tot chole, triglycerides |
| Red Yeast Rice | The Percent Change in HDL-C, Total Cholesterol, and Triglycerides for Placebo vs the Dietary Supplements. | Difference in percent change triglycerides | 5.60 % change HDLC, tot chole, triglycerides |
| Red Yeast Rice | The Percent Change in HDL-C, Total Cholesterol, and Triglycerides for Placebo vs the Dietary Supplements. | Difference in percent change total cholesterol | -1.16 % change HDLC, tot chole, triglycerides |
| Red Yeast Rice | The Percent Change in HDL-C, Total Cholesterol, and Triglycerides for Placebo vs the Dietary Supplements. | Percent change from baseline total cholesterol | -2.60 % change HDLC, tot chole, triglycerides |