A Study Investigating the Effects of Neprinol Study Product on Vascular Function

NCT02862223 | Completed Phase 2

• 1 other identifier: AAME1000
• Study Type: interventional
• Target: 14
• Locations: 0 countries
• Sites: N/A

Brief Summary

This open-label study investigated the effectiveness of Neprinol on maintaining healthy cardiovascular health in overweight and obese adults. Subjects took 3 capsules, 3 times per day over a period of 12 weeks.

Conditions

Obesity; Overweight

Keywords

Coagulation; Circulatory Function; Blood Pressure; Inflammatory response; Blood Glucose; Healthy vascular function

Outcome Measures

Primary Outcomes (11)

• The change in levels of D-Dimer after 12 weeks of supplementation with the study product.

  12 weeks

• The change in levels of Fibrinogen after 12 weeks of supplementation with the study product.

  12 weeks

• The change in levels of PAI-1 after 12 weeks of supplementation with the study product.

  12 weeks

• The change in levels of Fibrin Monomer after 12 weeks of supplementation with the study product.

  12 weeks

• The change in levels of Thrombin anti-thrombin III after 12 weeks of supplementation with the study product.

  12 weeks

• The change in levels of ESR after 12 weeks of supplementation with the study product.

  12 weeks

• The change in levels of PTT after 12 weeks of supplementation with the study product.

  12 weeks

• The change in levels of PT-INR after 12 weeks of supplementation with the study product.

  12 weeks

• The change in levels of Activated Clotting Time after 12 weeks of supplementation with the study product.

  12 weeks

• The change in levels of Platelet Count after 12 weeks of supplementation with the study product.

  12 weeks

• The change in Whole Blood Viscosity after 12 weeks of supplementation with the study

  12 weeks

Secondary Outcomes (10)

• The change in circulatory function after 12 weeks of supplementation with the study product, measured by EndoPAT analysis

  12 weeks

• The change in blood pressure after 12 weeks of supplementation with the study

  12 weeks

• The change in levels of HS-CRP after 12 weeks of supplementation with the study product

  12 weeks

• The change in levels of Adiponectin after 12 weeks of supplementation with the study product

  12 weeks

• The change in levels of IL-6 after 12 weeks of supplementation with the study product

  12 weeks

Other Outcomes (2)

• The change in CBC levels after 12 weeks of supplementation with the study product

  12 weeks

• The number of Adverse Events reported after 12 weeks of supplementation with the study product

  12 weeks

Study Arms (1)

Neoprinol

EXPERIMENTAL

Dietary Supplement: Neoprinol

Interventions

Neoprinol DIETARY_SUPPLEMENT

Neoprinol

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy male or female ≥ 18 and ≤ 75 years of age.
• Overweight subjects (BMI ≥ 27 and \< 30) and Obese subjects (BMI \> 30 and ≤ 35)
• Subjects with elevated cholesterol.
• Total cholesterol 240 mg/dL.
• Subjects with elevated inflammation
• HS-CRP ≥ 3 mg/L.
• Judged by the Investigator to be in general good health on the basis of medical history.
• Females of child bearing potential must agree to use appropriate birth control methods during the entire study period.
• Agree not to initiate any new exercise or diet programs during the entire study period.
• Agree not to change their current diet or exercise program during the entire study period.
• Understands the study procedures and signs forms providing informed consent to participate in the study and authorization for release of relevant protected health information to the study investigator.

You may not qualify if:

• Subjects with a history of congestive heart failure (any classification), unstable angina, or acute coronary syndrome within the past 30 days.
• Uncontrolled hypertension (blood pressure ≥ 170/100 mm Hg)
• Subjects with a history of gastrointestinal disease or surgery affecting absorption
• Subjects with peripheral arterial disease
• Daily use of NSAIDs, however 81mg of aspirin daily for cardio protection is allowed
• Daily use of anti-inflammatory or omega-3-fatty acid dietary supplements
• week washout is allowed
• Use of any immunosuppressive drugs in the last 12 months (including steroids or biologics)
• Any significant GI condition that would severely interfere with the evaluation of the study product including but not limited to inflammatory bowel disease (Ulcerative Colitis or Chron's), history of frequent diarrhea, history of surgery for weight loss (including gastric bypass or lapband), history of perforation of the stomach or intestines, gastroparesis, clinically important lactose intolerance
• Subjects with a history of using diabetic medications during the prior 4 weeks to study start
• Subjects with a history of using insulin during prior 12 weeks to study start.
• Any active infection, or infection in the last month requiring antibiotics, anti-viral medication, or hospitalization
• History or presence of cancer in the prior two years, except for non-melanoma skin cancer.
• Subjects with a history of seizure
• Recent history of (within 12 months) or strong potential for alcohol or substance abuse.

Sponsors & Collaborators

• KGK Science Inc.: lead
• Arthur Andrew Medical: collaborator

MeSH Terms

Conditions

Obesity; Overweight; Thrombosis

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Aaron Gillam

  Arthur Andrew Medical

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2016
• First Posted: August 10, 2016
• Study Start: March 1, 2012
• Primary Completion: March 1, 2014
• Last Updated: January 9, 2017

Record last verified: 2017-01