Eligibility Details:
Inclusion Criteria:
- Men: Total HDL of equal to or less than 38 mg / dL in men AND a low HDL-P of less than
or equal to 7200 by Spectracell LPP Plus.
- Women: Total HDL equal to or less than 45 mg/dl in women, AND a low HDL-P of less than
or equal to 7200 by Spectracell LPP Plus.
- Willingness to maintain current lifestyle (diet and exercise) practices
- Willingness to eat fish no more than twice per week and keep intake stable throughout
the study
- Willingness to give written informed consent to participate in the study
- Willingness to follow lifestyle instructions for 24 hours prior to the study visit.
- No known food allergy or intolerance to the ingredients in the study product (fish,
shellfish)
- Not currently taking (washout of at least 30 days required) any other supplements that
would interfere with the study results
- Not currently taking (washout of at least 30 days required) any other supplements
designed to support HDL.
Exclusion Criteria:
- Use of medications classified as narcotics 30 days prior to Screening and for the
duration of the study.
- Use of an investigational drug or participation in an investigational study within 30
days prior to Day 1 and for the duration of the study.
- Current use (at least 30 days wash-out required) of any lipid lowering medication
which, in the view of the PI, may interfere with the results.
- Known allergy or hypersensitivity to study product.
- No initiation of a new or change of an existing exercise regimen within 15 days prior
to Day 1 and for the duration of the study.
- No initiation of a new or change of an existing food plan 30 days prior to Day 1 and
for the duration of the study.
- No current involvement or within 30 days of Day 1 of a significant diet or weight loss
program such as Atkin's or other Low-Carb diet programs, very low calorie liquid diet
programs (such as Optifast, Medifast and/or HMR) or any diet that has led to a weight
loss of 5% of body weight over a period of 10 weeks.
- No serious, unstable illnesses including cardiovascular, hepatic, renal,
gastrointestinal, respiratory, endocrine, neurologic, immunologic, or hematologic
disease.
- Known infection with Human Immunodeficiency Virus (HIV), Tuberculosis or Hepatitis B
or C.
- Subjects with a current diagnosis or personal history of:
- Previous myocardial infarction within 5 years, Unstable angina, Previous stroke
or transient ischemic attack (TIA) within 5 years, Uncompensated congestive heart
failure, Previous percutaneous transluminal coronary angioplasty (PCTA) or stent
within 5 years, Previous coronary artery bypass grafts (CABG) within 5 years
- Type 1 diabetes mellitus
- Any significant liver or kidney disease such as cirrhosis or non-alcoholic fatty
liver disease, glomerulonephritis, and/or undergoing dialysis treatment. Cr over
2.5 mg/dL.
- Any malignancy (with the exception of basal or squamous cell carcinoma of the
skin if adequately treated and no recurrence for >5 years).
- Any serious mental illness including depression, manic episodes, post-traumatic
disorder, obsessive-compulsive disorder, personality disorders, history of
attempted suicide or violence within 12 months prior to Screening and for the
duration of the study.
- Any personal history of bipolar disorders, schizophrenia or psychotic behaviors.
- Personal history of seizure disorder other than a single childhood febrile
seizure that fully resolved.
- Known presence of raised intraocular pressure or history of narrow angle
glaucoma.
- A major medical or surgical event requiring hospitalization within the preceding
3 months
- The presence of any disease which influences digestion and absorption of
nutrients
- History of any bariatric surgery procedure
- Consumption of alcohol the evening prior to any study visit
- Use of drugs of abuse (such as marijuana, cocaine, phencyclidine [PCP] and
methamphetamine) within 12 months prior to Screening and for the duration of the
study.
- History of alcohol abuse or a diagnosis of alcoholism within 12 months prior to
Screening and for the duration of the study.
- Inability to comply with study and/or follow-up visits.
- Any other concurrent condition which, in the opinion of the Investigator, would
preclude participation in this study or interfere with compliance.
- Pregnancy
- Females of child bearing age not on an accepted contraception control method
common.study.methods.has-drugs-no
common.study.methods.is-healthy-no
