- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02341924
Validating the "Foods for Health" Portfolio of Functional Food Products
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 Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Manitoba
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Winnipeg, Manitoba, Canada, R3T 6C5
- Richardson Centre for Functional Foods and Nutraceuticals
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-
-
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Minnesota
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Rochester, Minnesota, United States, 55905
- Mayo Clinic
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Portfolio of functional foods
A portfolio of functional foods provided as packaged shelf-stable food products (Step One Treatment) which will include foods such as oatmeal, pancakes, cranberry bars, chocolate bars, smoothies, and a sprinkle offering which can be added to almost any food to enhance its nutritional impact. All products are interchangeable in terms of their nutrients of interest and contain a minimum of 5 g of fibre, 1800 mg of omega-3 fatty acids, 1000 mg of phytosterols and 1800 µmol antioxidants per serving. Calorie counts range from 110-190 kcal per serving. |
|
Placebo Comparator: Control foods
Control products will be like-items drawn from the general grocery marketplace.
Test and control products will be packaged and coded identically.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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)
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Baseline (days 1 and 2) and Endpoint (days 29 and 30)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in fasting serum glucose
Time Frame: Baseline (days 1 and 2) and Endpoint (days 29 and 30)
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Homeostasis model of assessment for insulin resistance (HOMA-IR) index will also be calculated
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Baseline (days 1 and 2) and Endpoint (days 29 and 30)
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Change in fasting insulin
Time Frame: Baseline (days 1 and 2) and Endpoint (days 29 and 30)
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Homeostasis model of assessment for insulin resistance (HOMA-IR) index will also be calculated
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Baseline (days 1 and 2) and Endpoint (days 29 and 30)
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Change in fasting C-reactive protein
Time Frame: Baseline (days 1 and 2) and Endpoint (days 29 and 30)
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Baseline (days 1 and 2) and Endpoint (days 29 and 30)
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Rotimi E Aluko, PhD, University of Manitoba, Richardson Centre for Functional Foods and Nutraceuticals
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- B2014:113
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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