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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02341924
Other study ID # B2014:113
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 2015
Est. completion date September 29, 2017

Study information

Verified date April 2021
Source University of Manitoba
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date September 29, 2017
Est. primary completion date September 29, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 21 Years to 64 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Portfolio of functional foods

Control foods


Locations

Country Name City State
Canada Richardson Centre for Functional Foods and Nutraceuticals Winnipeg Manitoba
United States Mayo Clinic Rochester Minnesota

Sponsors (2)

Lead Sponsor Collaborator
University of Manitoba Manitoba Agri-Health Research Network

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in fasting serum lipids (total cholesterol, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol and triglycerides) Baseline (days 1 and 2) and Endpoint (days 29 and 30)
Secondary Change in fasting serum glucose Homeostasis model of assessment for insulin resistance (HOMA-IR) index will also be calculated Baseline (days 1 and 2) and Endpoint (days 29 and 30)
Secondary Change in fasting insulin Homeostasis model of assessment for insulin resistance (HOMA-IR) index will also be calculated Baseline (days 1 and 2) and Endpoint (days 29 and 30)
Secondary Change in fasting C-reactive protein Baseline (days 1 and 2) and Endpoint (days 29 and 30)
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