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Validating the "Foods for Health" Portfolio of Functional Food Products

Primary Purpose

Hypercholesterolemia

Status

Completed

Phase

Not Applicable

Locations

International

Study Type

Interventional

Intervention

Portfolio of functional foods

Control foods

About this trial

This is an interventional other trial for Hypercholesterolemia

Eligibility Criteria

21 Years - 64 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Mayo Clinic
Richardson Centre for Functional Foods and Nutraceuticals

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Portfolio of functional foods

Control foods

Arm Description

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.

Control products will be like-items drawn from the general grocery marketplace. Test and control products will be packaged and coded identically.

Outcomes

Primary Outcome Measures

Change in fasting serum lipids (total cholesterol, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol and triglycerides)

Secondary Outcome Measures

Change in fasting serum glucose

Homeostasis model of assessment for insulin resistance (HOMA-IR) index will also be calculated

Change in fasting insulin

Homeostasis model of assessment for insulin resistance (HOMA-IR) index will also be calculated

Change in fasting C-reactive protein

Full Information

NCT ID

NCT02341924

First Posted

December 10, 2014

Last Updated

March 16, 2023

Sponsor

University of Manitoba

Collaborators

Manitoba Agri-Health Research Network

1. Study Identification

Unique Protocol Identification Number

NCT02341924

Brief Title

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

2. Study Status

Record Verification Date

April 2021

Overall Recruitment Status

Completed

Study Start Date

September 2015 (undefined)

Primary Completion Date

September 29, 2017 (Actual)

Study Completion Date

September 29, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Manitoba

Collaborators

Manitoba Agri-Health Research Network

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hypercholesterolemia

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

60 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Portfolio of functional foods

Arm Type

Experimental

Arm Description

Arm Title

Control foods

Arm Type

Placebo Comparator

Arm Description

Control products will be like-items drawn from the general grocery marketplace. Test and control products will be packaged and coded identically.

Intervention Type

Other

Intervention Name(s)

Portfolio of functional foods

Intervention Type

Other

Intervention Name(s)

Control foods

Primary Outcome Measure Information:

Title

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 Outcome Measure Information:

Title

Change in fasting serum glucose

Description

Homeostasis model of assessment for insulin resistance (HOMA-IR) index will also be calculated

Time Frame

Baseline (days 1 and 2) and Endpoint (days 29 and 30)

Title

Change in fasting insulin

Description

Homeostasis model of assessment for insulin resistance (HOMA-IR) index will also be calculated

Time Frame

Baseline (days 1 and 2) and Endpoint (days 29 and 30)

Title

Change in fasting C-reactive protein

Time Frame

Baseline (days 1 and 2) and Endpoint (days 29 and 30)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Maximum Age & Unit of Time

64 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Rotimi E Aluko, PhD

Organizational Affiliation

University of Manitoba, Richardson Centre for Functional Foods and Nutraceuticals

Official's Role

Principal Investigator

Facility Information:

Facility Name

Mayo Clinic

City

Rochester

State/Province

Minnesota

ZIP/Postal Code

55905

Country

United States

Facility Name

Richardson Centre for Functional Foods and Nutraceuticals

City

Winnipeg

State/Province

Manitoba

ZIP/Postal Code

R3T 6C5

Country

Canada

12. IPD Sharing Statement

Citations:

PubMed Identifier

35079806

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.

Results Reference

derived

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Validating the "Foods for Health" Portfolio of Functional Food Products

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