Project co-financed by



 

Participating research organisations

• Nutrition Institute, Ljubljana (leading organisation)
• University of Ljubljana, Faculty of Pharmacy
• Faculty of Health Sciences Celje

Financing

• ARIS - Slovenian Research and Innovation Agency and Valens

Project leader

• prof.dr. Igor Pravst [SICRIS]

Project operation:

1.10.2023 - 30.9.2026

Food supplements (FS) are regulated as foods, which are marketed in pharmaceutical formulations, such as tablets, capsules, drops, sprays, etc. In contrast to medicines, FS are not intended for prevention or treating diseases, but can be legally labelled and marketed with health claims, which need to be approved as provided in Reg. 1924/2006. People use FS as a strategy to combat nutritional deficiencies and to promote general health. It is expected that almost half of the adult population regularly uses food supplements, and use of FS further increased during pandemic. This can be linked with expectations of users, that FS affect functioning of the immune system, but it should be noted that COVID-19 pandemic also affected mental health, and that higher prevalence of anxiety and sleep disorders were observed in some populations. Sleep quality is one of the basic needs of human beings and important for health, and can be affected by wide range of causes including genetic, medical and psychological conditions. Other factors that affect sleep also include age, medications, and environmental factors. Sleep problems are commonly characterized by one or more of symptoms like inability to fall asleep at night, inability to stay asleep at night, excessive daytime sleepiness, etc. Data show that about 20% of the population is experiencing sleep quality difficulties. In medicine sleep disorders are commonly treated with prescription drugs, while many people – particularly those with milder sleep disorders, are not on medical pharmacotherapy and can be also without any medical diagnoses. This population is a major user of food supplements targeting sleep quality. Such FS can be classified into: (a) FS containing melatonin – which is the only constituent for which sleep-related health claim was authorised in the EU at dosage 1 mg, but lower dosages of melatonin are commonly marketed without labelled health claims. Question arises, whether such usage has any meaningful effects. (b) plant based FS, which are commonly formulated with Valerian root (Valeriana officinalis), which has not yet been subject to scientific evaluation of health claims by the EFSA, but its traditional use is established in monographs. Question arises, if the effects of valerian are strong enough to be supported with results of human intervention studies, conducted using EFSA standards for substantiation of health claims.

Abstract

Assessment of labelling data from FS and investigation of possible misleading practices and potential risks for consumers will be performed within the first phase of the project. Labelling data will be collected from FS available in major sale channels, including pharmacies, specialised stores, and on-line stores. Possible misleading labelling practices will be also investigated. Further, the efficiency and safety of food supplements containing standardised Valeriana officinalis extract for improving sleep quality, using melatonin as active comparator will be studied. Placebo-controlled human intervention trial will be conducted on adult participants using validated measures, in line with EFSA recommendations for scientific substantiation of health claims. Investigation of consumer knowledge, behaviour and experiences related to dietary supplementation practices, particularly focusing on herbal products will be carried out. This will enable to identify knowledge gaps and need for additional communications, which will support consumers with informed choices. Food supplement producers will be supported for the responsible development of new products, and policy briefs will be developed to empower policymakers for evidence-based decisions related to food supplements.

Project goals

Applying a highly multidisciplinary approach, the proposed applied research project will address the following objectives:
• O1: Assessment of labelling data from FS and investigation of possible misleading practices and potential risks for consumers.
• O2: Assessment of the efficiency and safety of food supplements containing standardised Valeriana officinalis extract for improving sleep quality, using melatonin as active comparator.
• O3: Investigation of consumer knowledge, behaviour and experiences related to dietary supplementation practices, particularly focusing on herbal products.
• O4: Support of key stakeholders, including producers and policymakers.