Key Information
Project Title: Effectiveness and Safety of Dietary Supplementation for Sleep Quality
Call: Public Call for (Co-)Financing of Research Projects for 2023
Funder: ARIS – Slovenian Research and Innovation Agency
Project Number / Code: L7-50044
Project Duration: 1 October 2023 – 30 September 2026
Project Holder: Nutrition Institute
Funding Information: The project is co-financed by ARIS – Slovenian Research and Innovation Agency and Valens
Project Leader at FZVCE: Assoc. Prof. Dr. Barbara Gnidovec Stražišar
Project Description
According to legislation, dietary supplements (DS) are defined as foods marketed in pharmaceutical formulations such as tablets, capsules, drops, sprays, etc. Unlike medicines, DS are not intended to prevent or treat diseases, but they can be legally labeled and marketed with health claims that must be approved in accordance with Regulation No. 1924/2006. People typically use DS to ensure adequate nutrient intake and to support general health. Approximately half of adults regularly consume dietary supplements, and the prevalence of DS use increased further during the pandemic. This may be linked to users’ expectations that DS could influence immune system functioning. At the same time, it should be noted that the COVID-19 pandemic also affected mental health, with higher prevalence of anxiety and sleep disorders observed in some populations.
Sleep quality is one of the basic human needs and is essential for health, being influenced by various factors, including genetic, medical, and psychological conditions, as well as age, medication, and environmental factors. Sleep problems usually manifest with symptoms such as inability to fall asleep at night, difficulty maintaining sleep, or excessive daytime sleepiness. Data show that approximately 20% of the population experiences problems with sleep quality. In medicine, sleep disorders are usually treated with prescription drugs, while those with milder disturbances or poorer sleep quality are often left undiagnosed and untreated. These individuals are frequent users of dietary supplements aimed at improving sleep quality.Available DS for sleep quality can be broadly divided into:(a) DS containing melatonin – the only ingredient in the EU with an approved health claim at a dose of 1 mg, although lower doses are often marketed without health claims. The question arises whether such use has any significant effects. (b) Herbal DS, most commonly containing valerian root (Valeriana officinalis). Although its health claim has not yet been scientifically assessed by EFSA, its traditional use is described in monographs. The question remains whether the effects of valerian are strong enough to be supported by human intervention studies conducted according to EFSA’s standards for substantiating health claims.
Project Summary
In the first phase, the project will evaluate the labeling of dietary supplements for sleep quality available on the market, with a focus on potential consumer deception and health risks. We will examine the effectiveness and safety of a dietary supplement with standardized valerian root extract (Valeriana officinalis) to support sleep quality, compared with melatonin. For this purpose, a placebo-controlled intervention study will be conducted in adults, monitoring relevant indicators and following EFSA recommendations for substantiating health claims.
We will also investigate consumers’ knowledge, behavior, and experiences regarding dietary supplementation practices, with a focus on herbal products. This will enable the identification of knowledge gaps and the need for additional awareness-raising efforts to support more informed consumer choices. Support will be provided to key stakeholders, including manufacturers and policymakers. Dietary supplement manufacturers will be supported in the responsible development of new products.
The project results will contribute to the responsible development of innovations in the field of herbal dietary supplements, relevant not only in European markets but also globally. By evaluating the current situation regarding available dietary supplements, the project will provide insight into the supply and marketing of supplements intended for sleep quality. Based on project results, it will be possible to raise public awareness more effectively. This will be further supported by a cross-sectional study conducted among dietary supplement users. For policymakers, policy briefs with key findings will be prepared to facilitate evidence-based policy decisions.
Project Objectives
With a distinctly multidisciplinary approach, we aim to:
C1: Evaluate the labeling of dietary supplements for sleep quality with respect to potential consumer deception and health risks.
C2: Determine the effectiveness and safety of a dietary supplement with standardized valerian root extract (Valeriana officinalis) for supporting sleep quality, compared with melatonin.
C3: Explore consumers’ knowledge, behavior, and experiences regarding dietary supplementation practices, with a focus on herbal products.
C4: Support key stakeholders, including manufacturers and policymakers.
The project objectives are aligned with national strategic documents and those of the European Union, including the EU Strategic Framework for Health Promotion, which emphasizes improving the health and well-being of European citizens. Furthermore, the project addresses the Slovenian National Programme on Nutrition and Physical Activity 2015–2025, where one of the key goals is to support non-misleading labeling and communication practices.
