Clinical trial NCT01858376: Effect Of Capros Supplementation On Cardiovascular Disease Risk Factors In Humans
Official title: Effect Of Capros Supplementation On Cardiovascular Disease Risk Factors In Humans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hyperlipidemia
Keywords: LDL cholesterol
anti-hyperlipidemic
hyperlipidemic
Capros
Natural Supplement
Lead sponsor: Ohio State University
Sponsor class: OTHER
Collaborators: name: Natreon, Inc.
First posted: 2013-05-21
Enrollment: 24
Sex: ALL
Minimum age (years): 21
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Patients 21-70 years of age
* BMI 25-35

Exclusion Criteria:

* BMI \> 35 OR \< 25
* Smokers
* Individuals who are deemed unable to understand the procedures, risks and benefits of the study, i.e. Informed consent will be excluded
* Females who are pregnant as well as individuals who are therapeutically immuno-compromised will also be excluded in order to minimize the risk to such individuals (and fetus) and to decrease statistical variability and to minimize potential of confounders.
* Candidates for inclusion into the study will not include individuals as defined in 45 CFR 46 Subparts B, C and D, nor from any other population which may be considered vulnerable. Pregnant women are excluded to minimize the risk to such individuals (and fetus) and to decrease statistical variability and to minimize potential of confounders.

Primary outcomes:
measure: Change From Baseline in Lipid Profile
timeFrame: Baseline and 14 weeks
Secondary outcomes:
measure: Changes in High-Sensitivity C-reactive Protein
timeFrame: Baseline and 14 weeks
measure: C-reactive Protein
timeFrame: Baseline and 14 weeks
measure: Changes From Baseline in Platelet Aggregometry
timeFrame: Baseline and 14 weeks
Other outcomes:
Locations:
city: Columbus
country: United States
facility: The Ohio State University
state: Ohio
Study officials:
affiliation: Ohio State University
name: Chandan K Sen, PhD.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.