We are always looking for people who are willing to take part in clinical studies involving food supplements and pharmaceuticals

Why run studies involving food supplements and pharmaceuticals in stress research? Of course, it would be best if stress never actually happened. But it's not always possible to avoid stressful situations which, occasionally, can lead to stress-related health problems. Food supplements and pharmaceuticals can have a positive effect on these disorders and significantly improve quality of life. Clinical studies help us to translate research findings to the patient. It usually takes about 10 years to develop a drug, and the total costs of each can amount up to 500 million euros until the new substance is available to patients.

Independent ethics commissions (consisting of medical practitioners, theologists, lawyers and lay members) and health authorities supervise various aspects including:

  • the safety, tolerance and therapeutic effects of the new product
  • ensuring that a reasonable ratio between risk and benefit is maintained
  • the principle of the patients' voluntariness, which includes the right to withdraw from a study at any time
  • appropriate remuneration and fees

International guidelines such as the Declaration of Helsinki and the Principles of Good Clinical Practice also guarantee the high quality of the study and secure the participants' safety.

Carrying out the study

In principal, studies consist of:

Phase I – the safety and tolerance of a new pharmaceutical is tested on healthy younger adults (above 18 years of age) and later on healthy older participants (above 60 years of age).

Phase II – pharmaceuticals are used in patient studies, as in Phase I.

Phase III – the area of application and the interactions of this pharmaceutical with others are tested on several thousand participants.

Phase IV – these studies are carried out using approved pharmaceuticals and are often post-marketing observation studies.

A study is preceded by:

  • Your telephone or postal contact with our institute.
  • A detailed description of the proposed study, which is also known as the Declaration of Helsinki, provided by us. This contains detailed descriptions of the tested substance, the criteria for participation, the sequence of events, possible risks, the volunteer's rights and obligations, and his or her coverage.
  • A meeting with the principal investigator. Your questions will be answered during this meeting. Any necessary examinations will not commence until you have given your written agreement.

Three steps in the course of the study

  • 1.  The preliminary examination consists of an initial discussion and a thorough medical examination. This is when the base data is collected, such as the patient's height, weight and blood pressure as well as samples of blood, saliva and urine. Our primary interest are hormones changing under stress.
  • 2. Participation in the study is done on an out-patient basis and the course of events is based on the study report. Here too, stress-related hormonal changes in the saliva and blood are recorded. Blood pressure, temperature and heart rate readings help in the monitoring. Experienced staff carefully record the collected data and any specific events.
  • 3. Prior to ending your study visit, we check your status to ensure that your leave our institute as you arrived.

We are always looking for new participants for our studies!

Are you interested in new findings in stress medicine, and would you like to support our scientific activities? We will be pleased to inform you about our current studies. Please contact us via phone +49 (0) 651 9120 494 or e-mail: info(at)daacro.com.