- What is a clinical trial?
They are research studies that explore whether a medical strategy or treatment is effective or if the health claims associated with the product are accurate.
The only way that this can be tested for effectiveness and tolerance is with the help of volunteers.
- What is a Placebo-controlled trial?
A placebo- controlled trial is a type of trial in which a sub-population of the trial do not receive any of the product being tested. The placebo is generally a food production additive such as maltodextrin.
- Who oversees trials?
Our qualified Atlantia team of GPs, Nurses & Nutritionists in addition to an internationally recognised Scientific Committee.
- Why participate?
Free health check-up – At visits we accurately measure your BMI , Blood Pressure & perform blood analysis so we can inform you on health markers such as cholesterol. The blood drawing is performed by one of our research nurses or trained phlebotomists. Some trials also have added benefits such as free x-rays, DXA scans or MRI scans.
Compensation – You are compensated for your time and expenses for taking part in any of our study
Contributing to the advancement of science – Without trials it would not be possible for companies to show foods have any beneficial effect on health. So, by taking part in trials you are enabling these companies to create new health products for everyone. Provide health information & sometimes create a health product which can benefit everyone
- What happens during a trial
Trials can vary hugely in length, number of visits & the length of visits.
The majority of visits take no more than 1 hour and involve taking your anthropometric measurements (weight, height, BMI, waist-hip ratio) and your vitals (blood pressure, heart rate & temperature), along with a blood sample.
- What kind of products do you work with?
We use only foods, food derivatives & food extracts for our trials.
- What about your safety?
Yes, the majority of our trials use products which have no known risks or side effects. If there are any known risk associated with the product they are clearly stated in your Informed Consent which is given to you prior to the beginning of your first visit to our clinic.
All our staff are trained to conduct research trials according to ICH-GCP standards which ensure each participant is treated in the appropriate manner and a strict set of procedures is followed.
We focus solely on food products.
All trials approved by our local ethics committee which is a rigorous process – made up of consultants, regulatory specialists, nurses & the general public
- Who is eligible to participate in a trial?
We require people that are generally healthy for studies, but we often have trials aimed at people with certain conditions such as high cholesterol, asthma, indigestion and high blood pressure.
- What are the steps in taking part in a trial?
First, we ask volunteers to fill out a Pre-Screening Questionnaire which we then review for their eligibility. You are then contacted by one of our Recruitment Officers and if you are eligible a Telephone Screening Questionnaire will be carried out.
If you remain eligible, the next step is to attend a visit at our clinic in Blackpool.
Another assessment of your eligibility is then carried out and if you remain eligible, you are given a place on the study.
- Do I get compensated for participating?
Yes, all our participants are reimbursed for their time on Our studies, the payment amount varies for each study, however. Payment is in the form of a check and you are reimbursed when you have fully completed a study.
- What is informed consent?
Before you begin a clinical trial, you will be asked to read a document known as the Informed Consent Form. This document contains important details about the trial that you have expressed an interest in participating in. All Volunteers are required to sign this before they can be enrolled onto a trial.
- What are inclusion & exclusion criteria?
Inclusion criteria are requirements that participants must have in order to qualify for a study.
Exclusion criteria are characteristics that disqualify participants from a study.
Each trial has its own set of Inclusion & Exclusion criteria.
- What is a “washout”?
A washout refers to a period of time where you are asked to stop taking any foods, supplements and/or medicinal products in order to qualify you for a study.
A washout can also refer to the period between finishing one study and beginning a new one.
- I am participating in a study, can I leave?
- You can leave at any time during a study, please note however, you may not receive any reimbursement fee.
- I am planning a pregnancy/pregnant/breastfeeding, can I participate?
Unfortunately, unless specifically stated you are not eligible to participate on any studies.
- I have IBS/Coeliac disease, can I participate?
If you have been diagnosed with IBS or Coeliac disease you are unfortunately not eligible to participate on any of our studies, unless specifically stated. This is due to the permeability of the gut lining differing from the general population which can cause results of the study to be skewed.
- What other medical conditions are ineligible for studies?
The following are excluded from all studies unless otherwise stated;
- Eating disorders
- Psychiatric diseases
- Immunocompromised (HIV, antirejection medication, steroids >30 days)
- I filled out the Pre-Screening Questionnaire but heard nothing back?
- Due to the level of interest in trials, it can take some time to get in contact with everyone that has applied, so please be patient with us. If you are particularly interested in a trial, you can get in contact with us directly by phone or email and we will be happy to help.
- How long do I have to wait after completing one trial to begin another?
- Generally, we recommended 60 days between finishing one trial and beginning another, this length can differ between trials however. This is known as a “washout”.
- What type of samples do I need to provide?
Depending on the trial you may have to provide different types of samples, these include; Blood, saliva, stool, urine.
- Who is funding the trials?
Different sponsors (food-based companies) from around the world come to Atlantia and request us to conduct a trial on their behalf.
- Is my data confidential?
Yes, all your information is protected according to GDPR standards.
- How do I get removed from your database?
If you wish to not be contacted by us in the future, please contact firstname.lastname@example.org with your request.