Hyperlipidemia
Conditions
Keywords
LDL cholesterol, anti-hyperlipidemic, hyperlipidemic, Capros, Natural Supplement
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.
Interventions
DIETARY_SUPPLEMENTCapros 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.
Sponsors
Natreon, Inc.
Chandan K Sen
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 70 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Lipid Profile | 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
| Measure | Time frame | Description |
|---|---|---|
| Changes in High-Sensitivity C-reactive Protein | 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 |
| C-reactive Protein | Baseline and 14 weeks | C-reactive protein in blood as measured in a standard hospital laboratory. 12 weeks on supplementation data presented. |
| Changes From Baseline in Platelet Aggregometry | 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 24 |
| Total | 24 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Dropped d/t lab work not fitting criter | 4 |
Baseline characteristics
| Characteristic | Capros Dietary Supplement |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 24 Participants |
| Age, Continuous | 34.5 years STANDARD_DEVIATION 11.53 |
| Blood Pressure Diastolic | 76.91 mm Hg STANDARD_DEVIATION 6.92 |
| Blood Pressure Systolic | 116.87 mm Hg STANDARD_DEVIATION 7.19 |
| BMI (Body Mass Index) | 28.57 kg/m^2 STANDARD_DEVIATION 2.71 |
| Height | 171 cm STANDARD_DEVIATION 9.38 |
| Region of Enrollment United States | 24 participants |
| Sex: Female, Male Female | 12 Participants |
| Sex: Female, Male Male | 12 Participants |
| Weight | 185.19 lbs. STANDARD_DEVIATION 27.67 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 24 |
| serious Total, serious adverse events | 0 / 24 |
Outcome results
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
Time frame: Baseline and 14 weeks
Population: 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.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Capros Dietary Supplement | Change From Baseline in Lipid Profile | HDL cholesterol | 4.20 mg/dl |
| Capros Dietary Supplement | Change From Baseline in Lipid Profile | LDL cholesterol | 3.37 mg/dl |
| Capros Dietary Supplement | Change From Baseline in Lipid Profile | Total Cholesterol | -0.06 mg/dl |
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
Time frame: Baseline and 14 weeks
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Capros Dietary Supplement | Changes From Baseline in Platelet Aggregometry | ADP | 3.34 maximum % aggregation |
| Capros Dietary Supplement | Changes From Baseline in Platelet Aggregometry | AA | -9.56 maximum % aggregation |
| Capros Dietary Supplement | Changes From Baseline in Platelet Aggregometry | Collagen | 15.76 maximum % aggregation |
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
Time frame: Baseline and 14 weeks
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Capros Dietary Supplement | Changes in High-Sensitivity C-reactive Protein | 0.07 mg/dl |
Secondary
C-reactive Protein
C-reactive protein in blood as measured in a standard hospital laboratory. 12 weeks on supplementation data presented.
Time frame: Baseline and 14 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Capros Dietary Supplement | C-reactive Protein | 1.61 mg/L | Standard Deviation 1.18 |