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ObesityPhase 2NCT02862223

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

A Phase 2 study testing Neoprinol in people with Obesity and Overweight, run by KGK Science Inc..

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 yearsHealthy volunteers can take part
Conditions the study is for
Obesity, Overweight
What is being tested?
Neoprinol
Could I receive a placebo?
No, everyone receives an active treatment
How many people
14 participants
Where
No sites listed yet
Study dates
Mar 2012to Mar 2014
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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
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  • 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

About this study

Official title: Neprinol for Cardiovascular Health

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
Being tested
Neoprinol
Keywords
Coagulation, Circulatory Function, Blood Pressure, Inflammatory response, Blood Glucose, Healthy vascular function
Medical subject headings
Obesity, Overweight, Thrombosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NeoprinolDietary supplement

Study groups in NCT02862223
Study groupRoleWhat they receive
NeoprinolExperimentalNot described
Receives: Dietary Supplement: Neoprinol

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 12 weeks

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

    Measured: 12 weeks

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

    Measured: 12 weeks

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

    Measured: 12 weeks

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

    Measured: 12 weeks

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

    Measured: 12 weeks

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

    Measured: 12 weeks

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

    Measured: 12 weeks

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

    Measured: 12 weeks

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

    Measured: 12 weeks

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

    Measured: 12 weeks

Secondary outcomes (10)

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

    Measured: 12 weeks

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

    Measured: 12 weeks

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

    Measured: 12 weeks

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

    Measured: 12 weeks

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

    Change in inflammatory markers after 12 weeks of supplementation with Neprinol. Inflammatory markers: HS-CRP, Adiponectin, IL-6, TNF-alpha, VEGF

    Measured: 12 weeks

  6. The change in levels of VEGF after 12 weeks of supplementation with the study product

    Measured: 12 weeks

  7. The change in levels of TNF-alpha after 12 weeks of supplementation with the study product

    Measured: 12 weeks

  8. The change in NK Cell Cytotoxicity after 12 weeks of supplementation with the study product

    Measured: 12 weeks

  9. The change in lipid levels after 12 weeks of supplementation with the study product, measured as LDL, HDL and TG

    Measured: 12 weeks

  10. The change in Glucose AUC after 12 weeks of supplementation with the study product

    Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Aug 2016 (estimated)
  2. Study startMar 2012
  3. Primary completionMar 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
14 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02862223
Sponsor's protocol ID
AAME1000
Status last verified
Jan 2017
First submitted
28 Jul 2016
Last updated
9 Jan 2017
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Neoprinol in people with Obesity and Overweight, run by KGK Science Inc..

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The change in levels of D-Dimer after 12 weeks of supplementation with the study product. (time frame: 12 weeks). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02862223.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2017.

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