Clinical Trials
Orgaia has extensive experience in developing clinical trials to demonstrate the safety and efficacy of our products (or client products), inventions and solutions.
Overview
Human Intervention Studies
To support a food health claim and in order to prove the safety and bioefficacy of a functional food product, Orgaia team manages clinical trials for food and wellness industries. We specialize in human nutritional intervention studies to support health claims for inflammation and oxidative stress reduction. To provide full solutions from base concept to patent and health claim development, our staff have extensive experience in the design of a wide range of clinical trials in the following therapeutic areas :
- Brain Health
- Obesity and Diabetes
- Cardiovascular Health
- Immune Function
- Skin and Beauty
- Intestinal Health
- Bone, Muscle and Joint Health
Demonstration of clinical bioefficacy for a functional food product represents a critical step to be properly positioned in the marketplace and substantiate health effects and claims.
Our Teams
Our teams work with several leading hospitals, health centres, universities and research centers for the development of the trials. We also perform in vitro evaluations, in different cellular models, to study biological activities of our formulations, in order to identify possible mechanisms of action, useful to target its use in the health and functional food markets. We design nutritional intervention studies following the guideline suggested by the European Food Safety Authority (EFSA) and conduct clinical trials in accordance with the Good Clinical Practice (GCP) and local regulatory requirements.