Clinical Studies

Genetic basis for Prediction of non-responders to dietary Plant Sterol intervention (GenePredict-PS) 
NFH and Unilever R&D, Vlaardingen have come together collaborating on a study called “Genetic basis for Prediction of non-responders to dietary Plant Sterol intervention (GenePredict-PS)” with a mutual research interest through the Mitacs Converge pilot program. The study will be conducted at the Richardson Centre for Functional Foods and Nutraceuticals (RCFFN).

The objective of the double blind, placebo controlled, randomized two-period crossover clinical trial is to investigate and validate the genetic basis of LDL-cholesterol responsiveness to controlled administration of plant sterols in healthy volunteers with LDL-cholesterol levels >3.0 mmol/L.

The clinical study will recruit 64 individuals with specific single nucleotide polymorphisms (SNPs) associated with responsiveness to plant sterols from the general population by following a prospective recruitment scheme based on genotype. Using a priori recruitment, the study intends to recruit 8 individuals in each of the 8 most common combinations, also called genosets.

Study participants will consume two daily single portions of margarine providing a total of 2 g of plant sterols or a placebo margarine (without any added plant sterols) in a crossover fashion for 28 days, with a 28 day washout between phases.

LDL-cholesterol responsiveness to plant sterol consumption will be tested in these precisely selected individuals with specific genosets. These responsiveness characterization tests will generate the required data to validate the genoset based classifications of responders and non-responders.

The concept of a predictive responsiveness test for plant sterol supplementation is based on the findings of previously completed human nutrition intervention trials by Dr. Peter Jones’ research group at RCFFN1, 2. In a recent intervention trial, the response of LDL-cholesterol to plants sterol consumption was associated with SNPs in cholesterol 7 alpha-hydroxylase (CYP7A1, rs3808607) and apolipoprotein E (ApoE, rs7412 and rs429358) genes3.

A key discovery was that combinations of these SNPs (known as genosets) were found to interact with each other to form stronger associations with the magnitude of LDL-C lowering in response to plant sterol consumption than did each individually3.

The research outcomes of this study will provide valuable information on the associations between SNPs and the degree of responsiveness to plant sterol intervention. Such knowledge will propel the development of predictive responsiveness tests, thereby enabling health care professionals to offer client-specific cholesterol management recommendations.

Predicting the direction of response of LDL-cholesterol to plant sterol consumption would be helpful in identifying individuals who should consume plant sterols and individuals who should seek an alternative method of treatment for hypercholesterolemia.

Hypercholesterolemic individuals who are identified as responders using the predictive test will be advised to take plant sterol products for cholesterol lowering, while non-responders will be recommended to either modify the plant sterol doses or use other natural health products that may lower cholesterol.


  1. Rideout TC, Harding SV, Mackay D et al. (2010) High basal fractional cholesterol synthesis is associated with nonresponse of plasma LDL cholesterol to plant sterol therapy. Am J Clin Nutr 92, 41-46.
  2. Mackay DS, Gebauer SK, Eck PK et al. (2015) Lathosterol-to-cholesterol ratio in serum predicts cholesterol-lowering response to plant sterol consumption in a dual-center, randomized, single-blind placebo-controlled trial. Am J Clin Nutr 101, 432-439.
  3. Mackay DS, Gebauer SK, Eck PK et al. (2015) CYP7A1-rs3808607 and APOE isoform associate with LDL cholesterol lowering after plant sterol consumption in a randomized clinical trial. Am J Clin Nutr 102, 951-957.

Hypotensive actions of hemp protein hydrolysate in moderately hypertensive individuals
Elevated blood pressure is an established risk factor for the development of several cardiovascular diseases and renal failure. Bioactive peptides prepared from plant proteins have been shown to exhibit renin and angiotensin I-converting enzyme (ACE)-inhibitory properties for effective blood pressure management. Hemp seed protein (HSP), a byproduct from the industrial production of edible oil has been identified as an excellent source for antihypertensive peptide production.

NFH has been successful in engaging naturopathic clinics to support a clinical research study titled “Hypotensive actions of hemp protein hydrolysate in moderately hypertensive individuals”.

This pilot study examines the effects of 3 g/day hemp protein hydrolysate on systolic and diastolic blood pressure in healthy individuals with mild/moderately elevated blood pressure. The clinical study was modelled using a multi-centre randomized crossover human trial design, involving two 30-day intervention periods each separated by a 30-day washout period.

Volunteers from Dr.Michael Traub’s Lokahi Health Center and Dr. Tori Hudson’s A Woman’s Time participated in this clinical study. During one intervention, participants were provided with 3 capsules/day each containing 1 g of hemp hydrolysate (1000 mg hemp protein isolate caps-dose 1 TID); during the other they consumed 3 capsules/day each containing 1 g of cellulose powder TID.

Capsules were prepared at the NFH manufacturing facility under GMP. The research outcomes of this pilot research study will lead to the development of plant based peptide formulation that helps effectively combat hypertension and its associated disorders.

Other NFH products being studied using HUMAN clinical trials:

  • Inositol SAP
  • Trident SAP
  • Coriolus versicolor SAP
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