Validating the "Foods for Health" Portfolio of Functional Food Products
| Status: | Completed |
|---|---|
| Conditions: | High Cholesterol |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 21 - 64 |
| Updated: | 9/22/2018 |
| Start Date: | September 2015 |
| End Date: | September 29, 2017 |
Validating the "Foods for Health" Portfolio of Functional Food Products: Effects on Lipid and Blood Glucose Management in Individuals Intolerant of Statin (HMG-CoA Reductase Inhibitor) Therapy
The objective of this research project is to investigate the ability to affect cardiovascular
disease (CVD) risk factors through a novel, easily implemented functional food-based
approach. The goal of the proposed project is to evaluate the effect of a range of
proprietary products specifically formulated to deliver convenient pre-packaged
condition-specific foods to positively impact blood cholesterol levels in statin intolerant
and/or statin unwilling participants. The specific aim of this project is to evaluate the
changes in serum low-density lipoprotein (LDL)-cholesterol, triglyceride (TG) glucose,
insulin and high-sensitivity C-reactive protein (hsCRP) concentrations over a 4 week regimen
using healthy tasty foods which are self-selected by a statin intolerant patient group.
disease (CVD) risk factors through a novel, easily implemented functional food-based
approach. The goal of the proposed project is to evaluate the effect of a range of
proprietary products specifically formulated to deliver convenient pre-packaged
condition-specific foods to positively impact blood cholesterol levels in statin intolerant
and/or statin unwilling participants. The specific aim of this project is to evaluate the
changes in serum low-density lipoprotein (LDL)-cholesterol, triglyceride (TG) glucose,
insulin and high-sensitivity C-reactive protein (hsCRP) concentrations over a 4 week regimen
using healthy tasty foods which are self-selected by a statin intolerant patient group.
Inclusion Criteria:
Participants aged > 21 to < 65 years will be recruited on the basis of ability to give
informed consent and being unwilling to use or intolerant of at-least one statin
medication.
Exclusion Criteria:
Participants will be excluded if they are unable to speak/read in English or are unable or
unwilling to temporarily hold all statin/lipid lowering therapies including supplements
throughout the study period.
Participants with diabetes or severe obesity (body mass index, BMI, > 35 kg/m2) will be
excluded.
Women who are pregnant or planning to be pregnant during the study period will not be
eligible for the study.
Participants with any food allergies/intolerances, 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.) will be excluded.
Participants will not be eligible if their baseline fasting LDL-C is < 100 mg/dL or > 190
mg/dL; or evidence of tissue cholesterol deposition; if their 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
will also serve as an exclusion criterion.
Smokers will be excluded from the study.
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 will be excluded.
Individuals with uncontrolled hypertension having systolic blood pressure >150 mm Hg or
diastolic blood pressure >100 mm Hg will be excluded from the study.
We found this trial at
2
sites
Click here to add this to my saved trials
Winnipeg, Manitoba R3T 6C5
Phone: 204-474-8883
Click here to add this to my saved trials