HypercholesterolemiaNCT02341924
Validating the "Foods for Health" Portfolio of Functional Food Products
A study testing Portfolio of functional foods in people with Hypercholesterolemia, run by University of Manitoba at 2 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 21 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypercholesterolemia
- What is being tested?
- Portfolio of functional foods
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Sep 2015to 29 Sep 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Canada1 site
Richardson Centre for Functional Foods and Nutraceuticals
Winnipeg, Manitoba, R3T 6C5
About this study
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
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.
- Conditions
- Hypercholesterolemia
- Being tested
- Portfolio of functional foods, Control foods
- Medical subject headings
- Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Portfolio of functional foodsOther
Control foodsOther
| Study group | Role | What they receive |
|---|---|---|
| Portfolio of functional foods | Experimental | 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. Receives: Other: Portfolio of functional foods |
| Control foods | Placebo comparator | Control products will be like-items drawn from the general grocery marketplace. Test and control products will be packaged and coded identically. Receives: Other: Control foods |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in fasting serum lipids (total cholesterol, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol and triglycerides)
Measured: Baseline (days 1 and 2) and Endpoint (days 29 and 30)
Secondary outcomes (3)
Change in fasting serum glucose
Homeostasis model of assessment for insulin resistance (HOMA-IR) index will also be calculated
Measured: Baseline (days 1 and 2) and Endpoint (days 29 and 30)
Change in fasting insulin
Homeostasis model of assessment for insulin resistance (HOMA-IR) index will also be calculated
Measured: Baseline (days 1 and 2) and Endpoint (days 29 and 30)
Change in fasting C-reactive protein
Measured: Baseline (days 1 and 2) and Endpoint (days 29 and 30)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2015 (estimated)
- Study startSep 2015
- Primary completion29 Sep 2017
- Study completion29 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypercholesterolemiaStudies of the same condition, open and under way.
- More trials run by University of ManitobaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Collaborators
- Manitoba Agri-Health Research Network
- Responsible party
- Sponsor
- Investigators
- Rotimi E Aluko, PhD, Principal investigator, University of Manitoba, Richardson Centre for Functional Foods and Nutraceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02341924
- Sponsor's protocol ID
- B2014:113
- Status last verified
- Apr 2021
- First submitted
- 10 Dec 2014
- Last updated
- 20 Mar 2023
- Results posted
- No
Publications
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.
PubMed 35079806
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02341924
- Acronym / sponsor ID
- B2014:113
- Conditions
- Hypercholesterolemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Collaborators
- Manitoba Agri-Health Research Network
- Study start
- Sep 2015
- Primary completion
- 29 Sep 2017 (actual)
- Study completion
- 29 Sep 2017 (actual)
- First posted
- 19 Jan 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Portfolio of functional foods | Experimental | Other: Portfolio of functional foodsA 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. |
| Control foods | Placebo comparator | Other: Control foodsControl products will be like-items drawn from the general grocery marketplace. Test and control products will be packaged and coded identically. |
Who may qualify
- Ages
- 21 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Portfolio of functional foods | Other | Portfolio of functional foods |
| Control foods | Other | Control foods |
Primary outcome
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)
3 secondary outcomes
Change in fasting serum glucose
Time frame: Baseline (days 1 and 2) and Endpoint (days 29 and 30)
Change in fasting insulin
Time frame: Baseline (days 1 and 2) and Endpoint (days 29 and 30)
Change in fasting C-reactive protein
Time frame: Baseline (days 1 and 2) and Endpoint (days 29 and 30)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2023.
- Derived from this study: PubMed 35079806Kopecky 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rotimi E Aluko, PhD principal investigator
University of Manitoba, Richardson Centre for Functional Foods and Nutraceuticals
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Portfolio of functional foods in people with Hypercholesterolemia, run by University of Manitoba at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02341924, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2023.