Effect Of Capros Supplementation On Cardiovascular Disease Risk Factors In Humans

NCT01858376 | Completed Results

• 1 other identifier: 2012H0381
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Hyperlipidemia

Keywords

LDL cholesterol; anti-hyperlipidemic; hyperlipidemic; Capros; Natural Supplement

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Changes in High-Sensitivity C-reactive Protein

  Baseline and 14 weeks

• C-reactive Protein

  Baseline and 14 weeks

• Changes From Baseline in Platelet Aggregometry

  Baseline and 14 weeks

Study Arms (1)

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.

Dietary Supplement: Capros dietary supplement

Interventions

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.

Capros dietary supplement

Eligibility Criteria

• Age: 21 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chandan K Sen: lead
• Natreon, Inc.: collaborator

Study Sites (1)

The Ohio State University

Columbus, Ohio, 43210, United States

Location

Related Publications (9)

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  PMID: 22458571 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.

  PMID: 15464042 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.

  PMID: 8946264 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.

  PMID: 22701284 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.

  PMID: 3371432 RESULT

• 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.

  PMID: 25756303 DERIVED

MeSH Terms

Conditions

Hyperlipidemias

Condition Hierarchy (Ancestors)

Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Results Point of Contact

• Title: Chandan K. Sen
• Organization: The Ohio State University

chandan.sen@osumc.edu

6142477786

Study Officials

• Chandan K Sen, PhD.

  Ohio State University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 9, 2013
• First Posted: May 21, 2013
• Study Start: March 1, 2013
• Primary Completion: January 1, 2015
• Study Completion: January 1, 2015
• Last Updated: July 27, 2018
• Results First Posted: November 9, 2015

Record last verified: 2017-10

Locations

US (1)