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OpenTrials
Completed

NCT Number: NCT01858376

Effect Of Capros Supplementation On Cardiovascular Disease Risk Factors In Humans

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.

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Key information

Age range

21 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Ohio State University

Columbus, Ohio, 43210, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Change From Baseline in Lipid Profile

    Time frame: Baseline and 14 weeks

    Blood lipid panel including HDL, LDL, total cholesterol. Looking at Baseline to 12 weeks on supplement with a two week washout period

Secondary outcomes

  1. Changes in High-Sensitivity C-reactive Protein

    Time frame: Baseline and 14 weeks

    High-Sensitivity C-reactive Protein analysis in blood. Looking at Baseline to 12 weeks on supplement with a two week washout period

  2. C-reactive Protein

    Time frame: Baseline and 14 weeks

    C-reactive protein in blood as measured in a standard hospital laboratory. 12 weeks on supplementation data presented.

  3. Changes From Baseline in Platelet Aggregometry

    Time frame: Baseline and 14 weeks

    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

Sponsors and collaborators

Lead sponsor

Chandan K Sen

Other

Collaborators

  • Natreon, Inc.

Registry information

Acronym: Capros

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
May 21, 2013
Registry last updated
Jul 27, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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