NCT Number: NCT02341924
Validating the "Foods for Health" Portfolio of Functional Food Products
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.
Looking for future studies?
Notify MeKey information
Conditions
Age range
21 year–64 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
Richardson Centre for Functional Foods and Nutraceuticals, Winnipeg, Manitoba, Canada
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
Control foods
OtherPrimary outcomes
-
Change in fasting serum lipids (total cholesterol, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol and triglycerides)
Time frame: Baseline (days 1 and 2) and Endpoint (days 29 and 30)
Secondary outcomes
-
Change in fasting serum glucose
Time frame: Baseline (days 1 and 2) and Endpoint (days 29 and 30)
Homeostasis model of assessment for insulin resistance (HOMA-IR) index will also be calculated
-
Change in fasting insulin
Time frame: Baseline (days 1 and 2) and Endpoint (days 29 and 30)
Homeostasis model of assessment for insulin resistance (HOMA-IR) index will also be calculated
-
Change in fasting C-reactive protein
Time frame: Baseline (days 1 and 2) and Endpoint (days 29 and 30)
Sponsors and collaborators
Lead sponsor
University of Manitoba
Other
Collaborators
- Manitoba Agri-Health Research Network
Registry information
Official study 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
Important dates
- Study start
- 2015
- Primary completion
- 2017
- Study completion
- 2017
- First posted
- Jan 19, 2015
- Registry last updated
- Mar 20, 2023
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Related clinical trials
Published trials that share one or more normalized conditions with this study.
Alleviation of Hypercholesterolemia Through Newly Developed Cookies Supplementedwithpumpkin (Cucurbita Pepo L.) Seeds and Walnuts (Juglans Regia L.) Among Arthrosclerosispatients.
NCT07737067
Arthrosclerosis, Dyslipidemias
Lahore, Punjab Province, Pakistan
View Trial DetailsA Clinical Study in Children With Heterozygous Familial Hypercholesterolemia (HeFH) Aged 6 to 17 Treated Once Daily With Bempedoic Acid Oral Dosing (CLEAR Path 1)
NCT05694260
Dyslipidemias, Hypercholesterolemia
Los Angeles, California, United States
View Trial DetailsTo Evaluate the Safety and Pharmacokinetic Characteristics of AJU-C716 and C716R in Healthy Adults
NCT07655960
Dyslipidemia, Dyslipidemias
Seoul, South Korea
View Trial DetailsAssessing Outcomes of Enhanced Chronic Disease Care Through Patient Education and a Value-based Formulary Study
NCT02579655
Brain Diseases, Cardiovascular Diseases
Calgary, Alberta, Canada
View Trial Details