Effect Of Capros Supplementation On Cardiovascular Disease Risk Factors In Humans

Hyperlipidemia Clinical Trial

— Capros  

Official title:

Effect Of Capros Supplementation On Cardiovascular Disease Risk Factors In Humans

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01858376
• Other study ID #: 2012H0381
• Status: Completed
• Phase: N/A
• Start date: March 2013
• Est. completion date: January 2015

Study information

• Verified date: October 2017
• Source: Ohio State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Hyperlipidemia
• Hyperlipidemias
• Hyperlipoproteinemias

Intervention

Dietary Supplement:
• 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.

Locations

Country	Name	City	State
United States	The Ohio State University	Columbus	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Chandan K Sen	Natreon, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (8)

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. — View 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. Review. — View Citation

Carchietti E, Baldassarre M, Penco T, Leonardi M. Iopamidol 300-induced epilepsy: intensive treatment and pathogenic hypothesis. Neuroradiology. 1988;30(3):256-7. — View Citation

Gokce N, Frei B. Basic research in antioxidant inhibition of steps in atherogenesis. J Cardiovasc Risk. 1996 Aug;3(4):352-7. Review. — View 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. — View Citation

Rigaud JL, Gulik-Krzywicki T, Seigneuret M. Freeze-fracture electron microscopy study of bacteriorhodopsin oligomerization. Prog Clin Biol Res. 1988;273:99-104. — View 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. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
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	Baseline and 14 weeks
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	Baseline and 14 weeks
Secondary	C-reactive Protein	C-reactive protein in blood as measured in a standard hospital laboratory. 12 weeks on supplementation data presented.	Baseline and 14 weeks
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	Baseline and 14 weeks