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Module:  2.
Nutritional supplements bioactivity, functional properties and safety: in vitro & in vivo studies
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Given the importance of nutritional supplements and their potential impact on human’s overall nutrient intakes, as well as to the significance of investigating their toxicity and bio activity for human organism, it is essential scientists, risk managers, policy makers, industry and many more professionals to possess relevant competence. The aim of this module is to present knowledge about:

• Specifications and important health benefits of several bioactive nutrients

• Importance of reference values for nutrients for dietary intake

• Main aspects of a nutrient source safety evaluation

• Recognition of risk assessment framework

• Application Standards on the models available for testing bioactivity of nutritional supplements

• Methodologies developed to study mechanisms of pathogenesis

• Basic principles on how the knowledge acquired on disease mechanisms, allows understanding the mechanism of action

• Basic steps providing functional evidence for bioactivity of each nutritional supplement

• How to design and conduct clinical studies aiming at establishing the effectiveness of nutritional supplements on human health

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On successful completion of this module students will be able to:

1. Understand relevant EU legislation and regulatory issues of their use.

2. Estimate bioavailability and safety of the nutrients

3. Understand the importance of tolerable upper intake levels, and their safe use

4. Interpret the risk nutritional supplements to pose adverse health effects

5. Realize how to establish food based dietary guidelines.

6. Use multiple cell culture models and cell lines from different tissues

7. Interpret animal models of different human diseases

8. Understand how investigators can select the appropriate model to assess bioactivity of nutritional supplement based on the disease target and expected function of the nutrients

9. Screen bioactivity of isolated compounds or extracts that can be used as nutritional supplements

10. Creates guidelines on how to run the study in a way that ensures valid results

11. Understands all the necessary actions before beginning a clinical study

12. Learn how to analyze the results

13. Assess the impact of nutritional supplements on different health status

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Unit 2.1. Nutritional supplements in general
2.1.1. Bioactivity and functional properties of Nutritional Supplements
2.1.2. Dietary Reference Values (DRVs) for nutrients
2.1.3. Do we need nutritional supplements?
Unit 2.2. Legislation issues about nutritional supplements use
2.2.1. The European Legislative Framework
2.2.2. Vitamins and Minerals
2.2.3. Other substances used in food supplements in the EU
2.2.4. Evaluation of sources of nutrients
2.2.5. A global scope
Unit 2.3 Cell Culture models for bioactivity testing of extracts
2.3.1. Cell culture models of effects on cell proliferation and toxicity
2.3.2. Cell culture models for testing anti-inflammatory action
Unit 2.4. Animal and cell culture models of Obesity, Metabolic Diseases and Intestinal Inflammation
2.4.1. Animal and cell culture models of Obesity, Metabolic Diseases and Intestinal Inflammation
2.4.2. In vivo models of metabolic disease
2.4.3. Models of Intestinal Inflammation
Unit 2.5. Animal and cell culture models of skin homeostasis and repair, and cancer
2.5.1. Models of acute and chronic wound healing
2.5.2. Skin Inflammatory diseases: The model of Psoriasis
2.5.3. Animal models of Wound Healing and cutaneous repair
2.5.4. In vitro cell culture models of wound healing
2.5.5. Conclusion on animal and cell culture models of skin homeostasis and repair
2.5.6. Animal and cell culture models of Cancer
2.5.7. Models for assessing Genotoxicity of bioactive compounds
2.5.8. Animal Models of Cancer for assessing bioactivity of therapeutic compounds
2.5.9. Conclusions on animal and cell culture models of cancer
Unit 2.6 Models for assessing the impact of nutritional supplements in the gut microbiome
2.6.1. Animal models for assessing changes in the gut microbiome
2.6.2. Methods for assessing changes in the gut microbiome
Unit 2.7. Design of human clinical studies
2.7.1. Preparatory steps for a human clinical study on a nutritional supplement
2.7.2. How to conduct a human clinical study on a nutritional supplement
2.7.3. Analyzing the results of a human clinical study on a nutritional supplement
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Animal models of disease

Bioactive nutrients

Cancer

Cardiovascular disease

Cell culture models

Clinical study

Cognitive diseases

Dietary nutrient intake

Double-blind design

EU legislation for nutritional supplements

Evaluation of nutrient sources

Food health claims

Health

Metabolism

Microbiome

Nutrient sources

Nutritional supplement

Nutritional supplements use

Obesity

Performance

Reference values for nutrients

Tolerable upper intake levels for nutrients

Unit:  2.1.
Nutritional supplements in general
Unit:  2.2.
Legislation issues about nutritional supplements use
Unit:  2.3.
Cell Culture models for bioactivity testing of extracts
Unit:  2.4.
Animal and cell culture models of Obesity, Metabolic Diseases and Intestinal Inflammation
Unit:  2.5.
Animal and cell culture models of skin homeostasis and repair, and cancer
Unit:  2.6.
Models for assesing the impact of nutritional supplements in the gut microbiome
Unit:  2.7.
Design of human clinical studies