Esposito, Cristina (2022) Clinical trial management for food supplements: from design to monitoring. [Tesi di dottorato]

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Abstract

Introduction: In the European Union, food supplements fall into the macro-category of foods. Directive 2002/46/EC defines food supplements as “foodstuffs the purpose of which is to supplement the normal diet…”, and establishes harmonized rules for some ingredients, such as vitamins and minerals for the food supplements production. In the past, food supplements were intended only to supplement the deficient diet of some individuals who could not get enough nutrients. During the last twenty years there was an evolution on the role of food supplements. According to Regulation (EC) No 1924/2006, foodstuffs can reduce disease risk factors. The Ministerial guidelines report that the evolution of food Legislation in Europe has led to an increase in the number of efficacy clinical studies on foods to assess health effects. Methods: Like clinical pharmacological studies, the execution of human clinical studies on food supplements must follow the Good Clinical Practice (GCP), the international ethical and scientific quality standards for designing, recording and reporting trials that involve the participation of human subjects; and must take into account prior and binding opinion of the Ethics Committee. During my Ph.D. course, I designed and monitored clinical trials in accordance with GCP. The first two clinical studies reported in this thesis, concern alpha-lipoic acid (ALA). The first of which, tested the safety and the efficacy of ALA in the reduction of different forms of idiopathic pain, in normoglycemic subjects. The second study evaluated the pharmacokinetic parameters of a liquid formulation of ALA. The third clinical trial investigated the effect of E. angustifolium extract (EAE) after the daily intake of hard, gastric-resistant capsules for 6 months in the reduction of the symptoms in subjects with benign prostatic hyperplasia (BPH). The last clinical study was focused on the efficacy of arabinoxylans obtained from barley (AX) to reduce postprandial glycemia, in healthy subjects. Results. The first clinical study showed that after two months of orally treatment of ALA, none of subjects treated with ALA reported a decreased glycemia or adverse effects. Moreover, the treated subjects showed a significant reduction in two validated questionaries for pain. The second clinical trial on a liquid formulation of R-ALA shows that R-ALA was rapidly absorbed. The Cmax value is higher than the commonly recognized ALA therapeutic effect, and the AUC is higher than a racemic solid formulation of ALA. The clinical study on EAE demonstrated that EAE can be used in subjects with BPH, to improve their quality of life. The last clinical trial demonstrated that AX can reduce post-prandial glucose in a statistically significant way, compared to placebo, producing a lower insulinemic response, consequently. Conclusions: Clinical studies on food supplements represent a relatively new approach. Therefore, it is important to consider that only following a right methodological approach, it will be possible to put on the market safe and effective food supplements, tested with the highest scientific rigor.

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