MedTrace Logo

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

NCT02341924 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2023-03-20

No results posted yet for this study

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.

Conditions

Interventions

OTHER

Portfolio of functional foods

OTHER

Control foods

Sponsors & Collaborators

  • Manitoba Agri-Health Research Network

    collaborator OTHER

  • University of Manitoba

    lead OTHER

Principal Investigators

  • Rotimi E Aluko, PhD · University of Manitoba, Richardson Centre for Functional Foods and Nutraceuticals

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
21 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-09-30
Primary Completion
2017-09-29
Completion
2017-09-29

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02341924 on ClinicalTrials.gov