What is a clinical study?
Research
What is a clinical study?
Clinical studies
In nutrition
Clinical studies involve analyzing how foods, food constituents, or diets may contribute to the development or prevention of health problems such as cardiovascular diseases, obesity, diabetes, gastrointestinal and immune disorders, cognitive decline, and other conditions associated with aging or not. When conducted in accordance with a rigorous protocol, their results can be generalized to a large portion of the population.
Our clinical investigation unit has modern facilities and equipment that could be used to carry out all steps of a human clinical nutrition research project. All INAF clinical studies are in addition approved by the Health Science Research Ethics Board at Université Laval.
In order to participate in a clinical study, you must:
- meet the eligibility criteria;
- go to a pre-screening visit;
- give your consent to take part in the study;
- be willing to do the testing and measurements that will yield data, which are then analyzed by the research team;
- be available for meetings and follow-up visits.
Process
Recruitment
Projects are announced in local media (social media, newspapers, radio, and advertising inserts) and by email to a distribution list that can be registered free. These announcements include the project title and objectives, eligibility criteria, name of the scientist responsible, approval number by the ethics committee, as well as contact information for taking part in the project.
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Eligibility Criteria
In order to participate in a study, you must meet the eligibility criteria indicated in the advertisement. These, which vary from study to study, are determined to answer specific research questions. Participants are selected on the basis of characteristic required for each project (age, gender, blood cholesterol levels, whether or not they are taking certain medications, etc.).
Pre-Screening of Participants
If you meet the eligibility criteria and wish to participate in the study, you must contact the project coordinator who will determine, through additional questions, whether you are eligible. If that is the case, you will be invited to a pre-screening visit where more precise measurements (blood sample, weight and height measures, etc.) are taken to confirm your eligibility or not.
Meetings and Follow-Up Visits
Once your acceptance into the study is confirmed, you will be expected to sign a consent form confirming your wish to participate in the study. This consent is voluntary, and allows you to reconsider and change your mind at all times.
You will then need to follow the research protocol guidelines throughout the study. Each one has a separate protocol that dictates the type of intervention, testing and measurements done, recommendations to be complied during the study, number of scheduled visits, post-study follow-up, etc. The study can last from a few days to several months, according to the protocol.
Qualified
personnel
Clinical studies are supervised at INAF by experienced research staff. The teams consist of researchers, physicians, research professionals, nutritionists, nurses, and highly skilled technicians. The security and well-being of the participants are central to the research team’s concerns.
All clinical studies at INAF are approved by the Research Ethics Committee at Université Laval and are conducted in accordance with current ethical rules.
Consult ongoing studies
And what about ethics?
Each clinical study must respect important ethical standards. Listen in this video to a participant’s testimony about his or her experience, as well as clarifications made by INAF research professionals Louise Corneau and Amélie Charest, and researcher Sophie Desroches.
A high-tech
environment
The INAF’s Clinical Investigation Unit has modern facilities and equipment that could be used to carry out all steps of a clinical research project to be done at the same location. It includes a kitchen and dining room that are enabling to prepare and consume meals on site as well as a large sampling room with comfortable chairs for blood collecting. Certain research protocols require participants to spend several hours in the Clinical Unit.
They have access to amenities that make their stay at the clinic more enjoyable:
- Computers with Internet access;
- Television;
- Closed rooms for reading, working or resting.
It is advantageous
to contribute to research
The benefits of taking part in a clinical study in nutrition generally include:
- A dietary assessment and/or personalized nutritional advice by a nutritionist;
- The participation in group workshops/one-on-one meetings facilitated by health professionals;
- The dietary supplements, foods, or complete meals are provided free of charge (in certain studies only);
- An assessment of health status, and a health check-up given upon completion of the study.
- A financial compensation (for some studies only)
- A medical referral if needed.
Participating in a clinical study helps enrich his or her knowledge, and make an important contribution to the advancement of research in the area of human nutrition!
Consult ongoing studies
Frequently asked questions
Can I participate in multiple studies?
You can take part in several studies, but only one at a time. The delay between the end of one study and the beginning of another varies according to the research project nature. It can be from a few weeks to a few months, depending on the type of intervention received.
Am I eligible if I live outside the Quebec City region?
It depends on the constraints related to the research protocol in time investment and travel. The number of visits during the protocol and at a follow-up has great variability between studies. The project coordinator will determine with you whether it is possible or not to participate in the study.
Why do the eligibility criteria vary from study to study?
Eligibility criteria are established on the basis of scientific data. Clinical studies are designed to meet one or more specific objectives. In order to do so, selected participants must therefore have certain characteristics that will allow researchers to adequately respond to these objectives. Including people who do not meet the eligibility criteria may complicate the interpretation of results.
How do I proceed if I wish to participate in a clinical study?
You must first ensure that you meet the eligibility criteria mentioned in the recruitment advertisement. If this is the case, you must approach the project coordinator whose contact information appears in the announcement. By asking you some supplementary questions, the coordinator will verify your eligibility and, if applicable, invite you to a pre-screening visit.
Who funds clinical studies?
Funding sources come from Canadian and Quebec government agencies and non-governmental organizations (associations, foundations, private companies, etc.). Research funds at INAF come mainly from the following:
Canada
Natural Sciences and Engineering Research Council of Canada (NSERC)
Canadian Institutes of Health Research (CIHR)
Agriculture and Agri-Food Canada
Quebec
Fonds de recherche du Québec – Nature et technologies (FRQNT)
Fonds de recherche du Québec – Santé (FRQS)
Non-governmental or private organizations:
Canadian Diabetes Association
Heart and Stroke Foundation of Canada and Quebec
Dairy Farmers of Canada
Etc.
Is my medical practitioner can obtain a copy of the blood test results made as part of the research project?
You automatically receive medical follow-up, as a participant in a clinical study, from the physician on the research team. This person ensures that people who need particular medical attention over the duration of the study are followed adequately by their treating physician or any other qualified health professional.
Can I be followed up with a nutritionist once the clinical study ended?
Private nutrition services are available at the INAF’s Clinic at CEPIA. It is possible to consult a nutritionist from this clinic located in our premises following your participation in the research project. The clinic’s nutritionists offer a range of nutrition counseling services such as individual consultations, educational and interactive workshops, conferences, and small-group intervention programs. For additional information about these services, visit the CEPIA website.
If I am not eligible for one project, can I participate in another?
Not qualifying for a clinical study does not mean that you cannot take part in others. Each research protocol has its own eligibility criteria. In order to make sure you are eligible, you must contact the project coordinator who will confirm whether or not you can participate in the study.
Do I have to be perfectly healthy to participate in a clinical study? Am I eligible if I take medications?
It depends on the study type and the eligibility criteria for each study. Participants are selected based on certain characteristics that will allow the research team to meet specific objectives. For example, a study aimed at mitigating disease risk factors through a dietary shift will target at-risk individuals to develop the condition.
Being on medications does not necessarily constitute an exclusion from the project. Some potentially interfere with the measurements done during the study, while others are not a problem. It is also possible, with the agreement of your treating physician, to stop use of a medicine over the duration of the study. In order to ensure your eligibility, you must contact the project coordinator who will confirm whether or not you can participate in the study.
