NCT02765516

Genetic Basis for Prediction of Non-responders to Dietary Plant Sterol Intervention

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 43 (actual)
• Sponsor: University of Manitoba · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

Summary

The objective of this study is to utilize information on associations between genetic predisposition pertaining to multiple single nucleotide polymorphisms (SNPs) and the degree of responsiveness of low-density lipoprotein cholesterol (LDL-C) lowering to plant sterols (PS). The predictive potential of SNPs associated with PS responsiveness will be evaluated using a randomized human intervention trial examining responsiveness of lowering blood LDL-C levels to PS intervention.

Detailed description

On average plant sterol (PS) consumption of 2-3 grams a day leads to a \~10% decrease in low-density lipoprotein cholesterol (LDL-C). However, inter-individual response to PS consumption varies, with some individuals showing low or no reductions in LDL-C levels, while some even showing an increase in levels. Determining factors that predict the direction of response of LDL-C to PS would be helpful in identifying individuals who should consume PS and individuals who should seek another method of treating hypercholesterolemia. The objective of this research proposal is to test the a priori predictive potential of a combination of three single nucleotide polymorphisms (SNPs), i.e., genosets, previously associated with response to PS in a post-hoc manner. A clinical trial with a priori recruitment of participants based on genoset which will test LDL-C response to PS consumption using a randomized, double blind, placebo controlled crossover design is proposed.

Conditions

• Hypercholesterolemia
• Cardiovascular Disease

Interventions

Type	Name	Description
OTHER	Plant sterols	2.0g/day of plant sterols incorporated into margarine to be consumed for 28 days
OTHER	Placebo	Identical margarine without additional plant sterols to be consumed for 28 days

Timeline

• Start date: 2017-07-05
• Primary completion: 2019-12-31
• Completion: 2019-12-31
• First posted: 2016-05-06
• Last updated: 2020-06-01

Locations

1 site across 1 country: Canada