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| Name | Class |
|---|---|
| Natreon, Inc. | INDUSTRY |
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The hypothesis of this study is that the natural supplement Capros will decrease LDL levels, platelet aggregation, and serum concentrations of high sensitivity C-reactive protein in humans at risk for cardiovascular disease.
A non-randomized, longitudinal study to determine the effect of Capros supplementation on a lipid profile, platelet aggregation and high-sensitivity C - reactive protein in 30 volunteers at risk for cardiovascular disease.
-Herbal Polyphenols/Antioxidants: Role in Cardiovascular Disease Prevention: Phenolic compounds are dietary antioxidants found in plants that are shown to inhibit LDL oxidation, inhibit platelet aggregation and adhesion, decrease total and LDL cholesterol, and induce endothelium-dependent vaso-relaxation. [Lapointe, Vita, and Mendes]. Epidemiologic studies suggest that higher polyphenol intake from fruits and vegetables is associated with decreased risk for cardiovascular disease. Among the numerous plausible mechanisms by which polyphenols may offer cardiovascular protection, improvement of the endothelial function and inhibition of angiogenesis and cell migration and proliferation in blood vessels have been the focuses of recent studies. Antioxidants in polyphenols, in addition to protecting LDL cholesterol against oxidation, may act at a vascular cell level by limiting cellular production of reactive oxygen species, and, thus, cell-mediated LDL oxidation. In traditional Indian medicine, the gooseberry (Phyllanthus emblica) has been used for thousands of years as an effective source of polyphenols and antioxidants. "P. emblica is considered beneficial against various diseases namely cancer, diabetes, liver treatment, and various other diseases."[Hiraganahalli]. Capros®, from Natreon, Inc., is a cascading antioxidant ingredient derived from Phyllanthus emblica. It has been used in cosmetics and food-and-beverage formulations in many countries, and, based on extensive scientific research, also shows particular promise as a dietary supplement.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Capros dietary supplement | Other | Subjects will take Capros supplement (1 capsule) twice a day for 12 weeks.The subjects then will have blood drawn seven times throughout the course of the study. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Capros dietary supplement | Dietary Supplement | Study participants will have 2 to 3 baseline blood draws, 3 blood draws while taking Capros supplements and 2 wash out blood draws after finishing 12 weeks of Capros supplementation. Participants will attend 7 to 8 study visits (depending on number of baseline visits needed) and at each visit participants will have their blood drawn as well as height, weight, blood pressure, and pulse measured. |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Lipid Profile | Blood lipid panel including HDL, LDL, total cholesterol. Looking at Baseline to 12 weeks on supplement with a two week washout period | Baseline and 14 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in High-Sensitivity C-reactive Protein | High-Sensitivity C-reactive Protein analysis in blood. Looking at Baseline to 12 weeks on supplement with a two week washout period | Baseline and 14 weeks |
| C-reactive Protein |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chandan K Sen, PhD. | Ohio State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Ohio State University | Columbus | Ohio | 43210 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22903797 | Result | Brieger K, Schiavone S, Miller FJ Jr, Krause KH. Reactive oxygen species: from health to disease. Swiss Med Wkly. 2012 Aug 17;142:w13659. doi: 10.4414/smw.2012.13659. eCollection 2012. | |
| 3420138 | Result | Rigaud JL, Gulik-Krzywicki T, Seigneuret M. Freeze-fracture electron microscopy study of bacteriorhodopsin oligomerization. Prog Clin Biol Res. 1988;273:99-104. No abstract available. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Capros Dietary Supplement | Subjects will take Capros supplement (1 capsule) twice a day for 12 weeks.The subjects then will have blood drawn seven times throughout the course of the study. Capros dietary supplement: Study participants will have 2 to 3 baseline blood draws (as needed), 3 blood draws while taking Capros supplements and 2 wash out blood draws after finishing 12 weeks of Capros supplementation. Participants will attend 7 to 8 study visits (depending on number of baseline visits needed) and at each visit participants will have their blood drawn as well as height, weight, blood pressure, and pulse measured. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Capros Dietary Supplement | Subjects will take Capros supplement (1 capsule) twice a day for 12 weeks.The subjects then will have blood drawn seven times throughout the course of the study. Capros dietary supplement: Study participants will have 2 to 3 baseline blood draws, 3 blood draws while taking Capros supplements and 2 wash out blood draws after finishing 12 weeks of Capros supplementation. Participants will attend 7 to 8 study visits (depending on number of baseline visits needed) and at each visit participants will have their blood drawn as well as height, weight, blood pressure, and pulse measured. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in Lipid Profile | Blood lipid panel including HDL, LDL, total cholesterol. Looking at Baseline to 12 weeks on supplement with a two week washout period | number of participants analyzed is different from the participant flow module due to subjects who self reported non-compliance from pill count of the supplements and their data was not able to be used for this outcome measure. | Posted | Mean | 95% Confidence Interval | mg/dl | Baseline and 14 weeks |
|
14 weeks from baseline of beginning the supplement to 12 weeks of ending supplementation, followed by 2 weeks of washout.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Capros Dietary Supplement | Subjects will take Capros supplement (1 capsule) twice a day for 12 weeks.The subjects then will have blood drawn seven times throughout the course of the study. Capros dietary supplement: Study participants will have 2 to 3 baseline blood draws (as needed), 3 blood draws while taking Capros supplements and 2 wash out blood draws after finishing 12 weeks of Capros supplementation. Participants will attend 7 to 8 study visits (depending on number of baseline visits needed) and at each visit participants will have their blood drawn as well as height, weight, blood pressure, and pulse measured. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chandan K. Sen | The Ohio State University | 6142477786 | chandan.sen@osumc.edu |
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| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| ID | Term |
|---|---|
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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|
C-reactive protein in blood as measured in a standard hospital laboratory. 12 weeks on supplementation data presented.
| Baseline and 14 weeks |
| Changes From Baseline in Platelet Aggregometry | Adenosine Diphosphate (ADP), Arachidonic acid (AA), and Collagen (unsure about the specific type of collagen) agonists will be measured using optical platelet aggregometry. Looking at Baseline to 12 weeks on supplement with a two week washout period | Baseline and 14 weeks |
| 3405414 | Result | Carchietti E, Baldassarre M, Penco T, Leonardi M. Iopamidol 300-induced epilepsy: intensive treatment and pathogenic hypothesis. Neuroradiology. 1988;30(3):256-7. doi: 10.1007/BF00341838. |
| 22458571 | Result | Taleb A, Tsimikas S. Lipoprotein oxidation biomarkers for cardiovascular risk: what does the future hold? Expert Rev Cardiovasc Ther. 2012 Apr;10(4):399-402. doi: 10.1586/erc.12.32. No abstract available. |
| 15464042 | Result | Stoclet JC, Chataigneau T, Ndiaye M, Oak MH, El Bedoui J, Chataigneau M, Schini-Kerth VB. Vascular protection by dietary polyphenols. Eur J Pharmacol. 2004 Oct 1;500(1-3):299-313. doi: 10.1016/j.ejphar.2004.07.034. |
| 8946264 | Result | Gokce N, Frei B. Basic research in antioxidant inhibition of steps in atherogenesis. J Cardiovasc Risk. 1996 Aug;3(4):352-7. doi: 10.1177/174182679600300403. |
| 22701284 | Result | Hiraganahalli BD, Chinampudur VC, Dethe S, Mundkinajeddu D, Pandre MK, Balachandran J, Agarwal A. Hepatoprotective and antioxidant activity of standardized herbal extracts. Pharmacogn Mag. 2012 Apr;8(30):116-23. doi: 10.4103/0973-1296.96553. |
| 3371432 | Result | Brauer K, Schober W, Winkelmann E, Garey LJ. Topographic differences in retinal axons in the dorsal lateral geniculate nucleus of the rat: a quantitative reexamination using anterograde transport of horseradish peroxidase. Exp Brain Res. 1988;69(3):481-8. doi: 10.1007/BF00247302. |
| 25756303 | Derived | Khanna S, Das A, Spieldenner J, Rink C, Roy S. Supplementation of a standardized extract from Phyllanthus emblica improves cardiovascular risk factors and platelet aggregation in overweight/class-1 obese adults. J Med Food. 2015 Apr;18(4):415-20. doi: 10.1089/jmf.2014.0178. Epub 2015 Mar 10. |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| BMI (Body Mass Index) | Mean | Standard Deviation | kg/m^2 |
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| Blood Pressure Systolic | Mean | Standard Deviation | mm Hg |
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| Height | Mean | Standard Deviation | cm |
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| Weight | Mean | Standard Deviation | lbs. |
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| Blood Pressure Diastolic | Mean | Standard Deviation | mm Hg |
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| Secondary | Changes in High-Sensitivity C-reactive Protein | High-Sensitivity C-reactive Protein analysis in blood. Looking at Baseline to 12 weeks on supplement with a two week washout period | Posted | Mean | 95% Confidence Interval | mg/dl | Baseline and 14 weeks |
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| Secondary | C-reactive Protein | C-reactive protein in blood as measured in a standard hospital laboratory. 12 weeks on supplementation data presented. | Posted | Mean | Standard Deviation | mg/L | Baseline and 14 weeks |
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| Secondary | Changes From Baseline in Platelet Aggregometry | Adenosine Diphosphate (ADP), Arachidonic acid (AA), and Collagen (unsure about the specific type of collagen) agonists will be measured using optical platelet aggregometry. Looking at Baseline to 12 weeks on supplement with a two week washout period | Posted | Mean | 95% Confidence Interval | maximum % aggregation | Baseline and 14 weeks |
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