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

KGK Science

Status and phase

Completed

Phase 2

Conditions

Overweight

Obesity

Treatments

Dietary Supplement: Neoprinol

Study type

Interventional

Funder types

Industry

Other

Identifiers

NCT02862223

AAME1000

Details and patient eligibility

About

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.

Enrollment

14 patients

Sex

All

Ages

18 to 75 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

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.

Exclusion criteria

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
- 2 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.
Participation in a clinical study with exposure to any non-registered drug product within 30 days prior.
Individual has a condition the Investigator believes would interfere with his or her ability to provide informed consent, comply with the study protocol, which might confound the interpretation of the study results or put the person at undue risk. Including subjects who are Bed or wheelchair-bound
Untreated or unstable Hypothyroidism
Subjects with active eating disorder including anorexia nervosa, bulimia, and/or obsessive compulsive eating disorders
Pregnant, lactating, or unwilling to use adequate contraception during the duration of the study