A Study Validating the "Foods for Health" Portfolio of Functional Food Products, for People Unable to take Statin Drugs
Tab Title Description
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
- Rochester, Minnesota: 15-000304
NCT ID: NCT02341924
Sponsor Protocol Number: B2014:113
About this study
The purpose of this study is to evaluate the ability of a range of new, easy to use, proprietary food based products to affect cardiovascular disease (CVD) risk factors by positively impacting blood cholesterol levels in statin intolerant and/or statin unwilling participants.
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
- Age > 21 to < 65 years
- Able to give informed consent
- Unwilling to use or intolerant of at-least one statin medication
- Unable to speak/read in English
- Unable or unwilling to temporarily hold all statin/lipid lowering therapies including supplements throughout the study period
- Has diabetes or severe obesity (body mass index, BMI, > 35 kg/m2)
- Pregnant or planning to be pregnant during the study period
- Any food allergies/intolerances, or food restrictions due to medical, religious or philosophical reason - including Kosher, vegan, vegetarian, high protein, low-carbohydrate, low-phosphorus, etc. other than attempting to follow an eating plan as generally advocated by the American Heart Association (low sodium, low cholesterol, reduced fat, etc.)
- Baseline fasting LDL-C is < 100 mg/dL or > 190 mg/dL
- Evidence of tissue cholesterol deposition
- Baseline fasting TG is > 400 mg/dL or baseline fasting blood glucose is > 126 mg/dL
- Consumption of more than 2 alcoholic drink/day or history of alcoholism or drug dependence
- History of non-skin cancer
- History of melanoma
- History of rheumatoid arthritis or other chronic rheumatologic condition
- History of advanced cardiovascular disease
- Moderate or greater valvular disease
- History congestive heart failure
- Known coronary artery disease
- History dysrhythmias requiring medical or surgical intervention
- Known chronic liver or renal disease, diabetes, inflammatory bowel disease, celiac disease, uncontrolled thyroid disease, hormonal supplementation(other than thyroid), pancreatitis, gallbladder or biliary disease, neurological/psychological disease, and gastrointestinal disorders that could interfere with fat absorption
- Uncontrolled hypertension having systolic blood pressure >150 mm Hg or diastolic blood pressure >100 mm Hg
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
|Mayo Clinic Location
Mayo Clinic principal investigator
Stephen Kopecky, M.D.
Closed for enrollment
Publications are currently not available
Study Results Summary
Not yet available
Supplemental Study Information
Not yet available