Clinical trial NCT02341924: Validating the "Foods for Health" Portfolio of Functional Food Products
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypercholesterolemia
Lead sponsor: University of Manitoba
Sponsor class: OTHER
Collaborators: name: Manitoba Agri-Health Research Network
First posted: 2015-01-19
Enrollment: 60
Sex: ALL
Minimum age (years): 21
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change in fasting serum lipids (total cholesterol, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol and triglycerides)
timeFrame: Baseline (days 1 and 2) and Endpoint (days 29 and 30)
Secondary outcomes:
measure: Change in fasting serum glucose
timeFrame: Baseline (days 1 and 2) and Endpoint (days 29 and 30)
measure: Change in fasting insulin
timeFrame: Baseline (days 1 and 2) and Endpoint (days 29 and 30)
measure: Change in fasting C-reactive protein
timeFrame: Baseline (days 1 and 2) and Endpoint (days 29 and 30)
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Winnipeg
country: Canada
facility: Richardson Centre for Functional Foods and Nutraceuticals
state: Manitoba
Study officials:
affiliation: University of Manitoba, Richardson Centre for Functional Foods and Nutraceuticals
name: Rotimi E Aluko, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kopecky SL, Alias S, Klodas E, Jones PJH. Reduction in Serum LDL Cholesterol Using a Nutrient Compendium in Hyperlipidemic Adults Unable or Unwilling to Use Statin Therapy: A Double-Blind Randomized Crossover Clinical Trial. J Nutr. 2022 Feb 8;152(2):458-465. doi: 10.1093/jn/nxab375.