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Clinical Studies

Thoracic Peri-Operative Integrative Surgical Care Evaluation (TPOISE) Trial

Elevated blood pressure is an established risk factor for the The Patterson Institute for Integrative Oncology Research at the Canadian College of Naturopathic Medicine (CCNM) in partnership with the Ottawa Hospital (TOH) is conducting a multi-centre pragmatic Clinical Trial. NFH is supporting this study through the provision of specified natural health products which will be used as part of the intervention. The objective of the Thoracic Peri-Operative Integrative Surgical Care Evaluation (TPOISE) trial is to investigate the effects of adding pre- and post-surgery complementary therapies alongside standard care for patients undergoing surgery for lung, gastric or esophageal cancer.

The arm receiving integrative care will receive recommendations for physical activity, dietary changes, mental health support, and natural health product interventions, administered under the care of a naturopathic doctor (ND) alongside normal conventional treatments. More specifically, this study will examine the impact of integrative care vs. standard care alone in cancer patients and will assess the impact on quality of life including symptoms, fatigue, and anxiety, surgical complications, immune function, as well as the impact, if any, on cancer recurrence and mortality. Costs associated with this type of care will also be assessed. A total of up to 400 participants will be enrolled and randomized to either integrative care with a naturopathic doctor or standard care alone.

The interventions used in this pragmatic clinical trial include recommendations for physical activity using guidelines from the Canadian Society for Exercise Physiology; nutritional recommendations centred around the Mediterranean diet; mental health recommendations individualized to each participant that might include meditation, yoga, nature walks, time with family, and others; the natural health products being used in this study include vitamin D, Coriolus, fish oil, probiotics, whey protein, curcumin, and green tea extract. NFH Inc is providing the Coriolus and fish oil used in this study. The study is being carried out at the OICC (Ottawa Integrative Cancer Center) now known as the CHI (Center for Health Innovation) under the direction of Drs Dugald Seely and Andrew Seely. The study has been approved by Health Canada as well as the ethics review boards at the Canadian College of Naturopathic Medicine and the Ottawa Hospital.

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 by product 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.

Determination of Pharmacokinetics of Different Turmeric Extract Formulations

Project lead: Dr Shatha Hammad, Assistant Professor, University of Jordan

Project objective: The aim of this trial is to assess the pharmacokinetics of a novel water-soluble curcuminoid-rich turmeric extract preparation compared with two other conventional turmeric extract formulations.

Clinical trial details: The study is a double-blind crossover study of three arms of different turmeric extract preparations standardized to curcuminoids to determine the pharmacokinetics of curcuminoids of each preparation. Pharmacokinetics of a novel water-soluble curcuminoids standardized turmeric extract preparation with suggested high bioavailability are being compared with two other standard turmeric extract formulations. The novel water-soluble curcuminoid-rich turmeric extract as well as the other conventional formulations are NFH products. Participants are being recruited via flyers, social media, and campus mail. Twenty-five males and females are participating.

Study treatments: On each test day, participants consume each of three turmeric extract preparations, provided in the form of capsules. Sequence of treatment is randomized using computer-generated tables. Each arm consists of one day with the study arms separated by a one-week washout period. To increase the consistency among participants, all participants consume the same evening meal on the day before each test day. This meal is provided to them on the day that precedes the test day. On the evening before test day, participants are instructed not to perform exercise, and to consume the same evening meal before fasting for 12 hours. On each test day, fasting blood samples are being collected, followed by the consumption of one of the three treatments, followed by further blood sampling. The day after, participants return to the experiment site to collect an additional fasting blood sample.

Ethics: This study is being conducted at the University of Jordan where the Institutional Review Board reviews and approves the proposal. The protocol of this study conforms to the ethical standards of the responsible committee on human experimentation. Written informed consent is completed and obtained before starting data collection.

Data collection: Personal and anthropometric data are being collected from each participant. Anthropometric data include body weight and height. Weight is measured using a calibrated portable scale with minimal clothing and without shoes. Standing height is measured, without shoes, using a calibrated portable measuring rod. Body mass index (BMI) is calculated as the ratio of weight in kilograms to the square of height in meters.

Sample analysis: Extraction of curcuminoids is conducted and then analyzed by LC-MS/MS.

Effects of Plant Sterol Supplementation on Lipid Profiles and Liver Enzymes in Patients with Nonalcoholic Fatty Liver Disease: A Double-Blind, Placebo-Controlled, Randomized Clinical Trial

Project lead: Dr Shatha Hammad, Assistant Professor, University of Jordan

Project objective: The aim of this trial is to explore the therapeutic potential of plant sterol supplementation against nonalcoholic fatty liver disease (NAFLD).

Clinical trial details: The study is a double-blind crossover trial involving 70 adult patients, male and female, diagnosed with NAFLD by liver ultrasonography, and who meet the inclusion criteria. The 70 patients are being randomly divided into two groups: the plant sterol and control groups with enrolment targets of n=35 each.

Study treatments: Participants in the study treatment group receive 1.6 g oral plant supplement which will be consumed with meals daily. The plant sterol is that used in the NFH Chol-SAP product. Those in the control group receive a placebo capsule daily. Each treatment extends for eight weeks and the actual treatment phases are preceded by a two-week run-in period, in which the participants consume their regular diets with normal food items. Body weight, BMI, and body composition are assessed at the end of the study. Dietary intake is being assessed using three-day food records at the beginning and at the end of the study and analyzed using Food Processor Nutrition Analysis Software. Blood pressure is being measured by a registered nurse with subjects resting using electronic monitors. Two readings are conducted and the mean calculated. Fasting blood samples are being collected from each participant after fasting for 10-12 hours at baseline (week 0) and at the end of the study (week 8) by a registered nurse. Participants are instructed to abstain from consuming caffeinated beverages, as well as from any type of exercise for 12 hours prior to blood draws.

Ethics: This study is being conducted at the University of Jordan where the Institutional Review Board reviews and approves the proposal. The protocol of this study conforms to the ethical standards of the responsible committee on human experimentation and is in compliance with the Helsinki declaration. Written informed consent is being completed and obtained from each participant before starting data collection.

Data collection: Personal and anthropometric data are being collected from each participant. Anthropometric data include body weight and height. Plasma lipid and enzyme activity assessment testing is being carried out.

Sample analysis: Alanine aminotransferase (ALT), aspartate aminotransferase (AST), as well as lipid profiles including (plasma HDL, TG, total cholesterol), insulin, and glucose levels in plasma are being analyzed by autoanalyzer.

Evaluation of Current Strength of Evidence for Single Nuclear Polymorphisms (SNPs) used in Nutrigenetic Studies Examining Effects of Genetic Profiling on Responsiveness of Health Risk Biomarkers to Natural Product Supplementation.

Project lead: Dr Charles Desmarchelier, Assistant Professor, University of Marseilles

Project objective: The aim of this project is to carry out a systematic review of standards of evidence available in support of single nuclear polymorphisms within genes coding for enzymes and transporters predicting responsiveness of health risk markers to nutrition and natural health product consumption. 

Research project details:  This project issurveying SNPs currently being utilized by commercial service providers in the personalized health arena including MyChrome Inc, then systematically evaluating the scientific data in support of any asserted link between individual SNPs and responsiveness of a disease risk biomarkers to supplementation with specific nutritional or natural health product interventions. Currently, several companies offer genetic testing services with the aim of optimizing lifestyle and nutritional recommendations based on patients’ ancestral/genetic profiles. Many of these providers look at minor structural base-pair building block substitutions termed SNPs in genes coding for important enzyme/transporter/signaling molecules that are situated at critical regulatory points within substrate pathways. For any given gene, certain SNP profiles will predict suboptimal substrate flow along a metabolic pathway compared with alternate SNP profile, necessitating a greater amount of nutrient or natural health product supplement to enable normal flux for that pathway. The problem with this very recent area of science is that the amount of peer-reviewed published evidence is uneven across the various gene-natural product associations. Accordingly, the present undertaking involves a team of objective third-party skilled investigators in the field who are first identifying the list of SNPs currently being marketed as predictive of nutritional/natural product usage, then reviewing, evaluating, and scoring the available evidence in support of each suggested SNP-natural product association. Using a pre-established matrix grid, multiple criteria surrounding quality and relevance of individual published peer-reviewed studies are being assessed for at least 138 individual SNPs. It is anticipated that the output of this research will enable practitioners and patients to use genetic profiling service providers with greater confidence, based on the quality of evidence backstopping individual SNP tests these providers offer.

Effect of Protein Source during a Ketogenic Weight Loss Intervention on Lipid Metabolism and Inflammation

Ketogenic Weight Loss

Project lead: Dr Sylvia Santosa, Associate Professor, Concordia University

Project objective: The objective of this clinical nutrition interventional study is to systematically investigate how lipid levels and inflammatory pathways are affected during a plant- or animal-based ketogenic weight loss dietary intervention. The hypothesis is that highly polyunsaturated triglycerides and inflammatory markers will be higher in the group consuming plant protein than animal protein, by comparing pre- and post-intervention lipid levels of more than 500 measured lipids.

Clinical trial details:

Study treatments:  Obese individuals (n=16 per group) are being fed a hypocaloric ketogenic diet, supplemented with either animal-based or plant-based protein, for 12 weeks. The plant-based diet is utilizing NFH lupine and pea-based proteins. All participants are undergoing two study visits, before and after a 12-week weight loss period. Prior to each study visit, participants undergo a 2-week weight stabilization period after which 24-hour urine is collected for measurement of protein oxidation. For each study visit, participants arrive in the morning fasted and have a baseline indirect calorimetry measurement and blood draw. Participants then consume a protein shake containing either NFH whey-based protein or the plant-based protein. Hourly resting indirect calorimetry measurements are then performed for 6 hours during peak fat absorption. Whole body dual x-ray absorptiometry (DXA) is conducted for measurement of regional body composition.

Ethics: Ethics approval is being obtained from Concordia University and informed consent obtained prior to any of these procedures.

Data collection: Calorimetry, DXA, and traditional clinical markers including insulin, inflammatory markers (IL6, TNFα), and hormones/adipokines (eg leptin, adiponectin) are being measured to monitor weight loss and overall health status. Fasting blood samples are being used to examine the differences in lipid profiles before and after diet intervention and based on the protein source.

Sample analysis: Body composition is being measured via DXA scan. Resting metabolic measurements are being conducted for 30 minutes after an overnight fast and a 90-minute rest period by indirect calorimetry. After each protein supplement, 10-minute indirect calorimetry measurements continue hourly for a six-hour period. Insulin, inflammatory cytokines, and adipokines are analyzed in blood via Luminex or ELISA. Immune cells are being characterized by flow cytometry using established procedures.

Other NFH products being studied using HUMAN clinical trials: