Chapter 6 & Chapter 7

GTU 2030 Global Technopreneur University 2030

  • JUTHM: Universiti Tun Hussein Onn Malaysia 1993-2023

  • Theme: Amanah Profesional Inovatif

  • Course: BWD 32603 Functional Foods and Nutraceuticals

  • Instructor: Dr. Mohamad Zulhafiz Shafiq Bin Zulhilmi Cheng

  • Rating: Excellent QS STARS™ Rating System

  • Media: Subscribe to UTHM TV

6.0 Efficacy & Safety of Functional Food & Nutraceuticals

  • Overview of antioxidant and health

  • Relationship of bioactive compounds to health benefits and disease treatment

  • Evaluation through animal models and human clinical trials

  • Identification of appropriate biomarkers

6.1 Overview: Antioxidants and Health

  • Antioxidant Sources:

    • Vitamin C (Ascorbic Acid): Found in citrus fruits, strawberries, bell peppers, broccoli.

      • Mechanism: Neutralizes free radicals by donating electrons.

      • Benefits: Boosts immunity, promotes skin health, supports collagen synthesis.

      • Associated Diseases: Cardiovascular diseases, scurvy.

    • Vitamin E: Found in nuts, seeds, vegetable oils, spinach.

      • Mechanism: Protects cell membranes from oxidative damage.

      • Benefits: Reduces inflammation, supports eye health, slows aging.

      • Associated Diseases: Alzheimer’s disease, macular degeneration.

    • Polyphenols: Found in green tea, berries, dark chocolate, red wine.

      • Mechanism: Scavenge free radicals, modulate signaling pathways.

      • Benefits: Anti-inflammatory, anti-cancer, neuroprotective.

      • Associated Diseases: Cancer, neurodegenerative diseases.

    • Carotenoids: Found in carrots, sweet potatoes, tomatoes, spinach.

      • Mechanism: Quench singlet oxygen and neutralize free radicals.

      • Benefits: Supports vision, reduces risk of certain cancers.

      • Associated Diseases: Macular degeneration, skin cancer.

    • Selenium: Found in Brazil nuts, seafood, eggs.

      • Mechanism: Component of antioxidant enzymes (e.g., glutathione peroxidase).

      • Benefits: Supports thyroid function, protects against oxidative stress.

      • Associated Diseases: Thyroid disorders, cardiovascular diseases.

    • Flavonoids: Found in citrus fruits, onions, tea, soybeans.

      • Mechanism: Inhibit lipid peroxidation and reduce oxidative stress.

      • Benefits: Cardiovascular protection, anti-inflammatory effects.

      • Associated Diseases: Cardiovascular diseases, cancers.

    • Coenzyme Q10: Found in meat, fish, whole grains.

      • Mechanism: Participates in mitochondrial energy production.

      • Benefits: Improves heart health, reduces oxidative damage.

      • Associated Diseases: Heart failure, neurodegenerative diseases.

    • Zinc: Found in meat, shellfish, legumes, nuts.

      • Mechanism: Stabilizes cell membranes, prevents oxidative damage.

      • Benefits: Boosts immunity, promotes wound healing.

      • Associated Diseases: Immune deficiencies, chronic inflammation.

Case Study: Vitamin A

  • Safety Concerns: Excessive intake can lead to toxicity (symptoms: nausea, dizziness).

  • Case Examples:

    • High-dose supplements or large animal liver consumption increased toxicity risks.

    • Regulatory bodies established RDAs to guide safe intake levels.

  • Conclusion: Highlights the need for safe upper limits and clear guidelines to prevent excessive consumption.

Interaction Types

  1. Nutrient-Nutrient Interactions:

  • Competition for absorption may affect bioavailability.

  • Synergistic effects can enhance absorption or utilization.

  1. Nutrient-Drug Interactions:

  • Bioactive compounds may alter drug absorption and metabolism.

  1. Drug-Drug Interactions:

  • Altered pharmacokinetics can change absorption, distribution, metabolism, or elimination.

  • Pharmacodynamic interactions may enhance/diminish drug effects.

Factors Influencing Interactions

  1. Dosage and Timing: Timing and amount can influence interactions.

  2. Individual Variability: Genetic, age, and health factors affect processing of substances.

Clinical Implications

  • Reduced medication efficacy and adverse effects from interactions.

6.2 Relationship of Bioactive Compounds to Health Benefits and Disease Treatment

  • Definition: Naturally occurring substances in food that exert physiological effects.

  • Examples: Polyphenols, flavonoids, carotenoids, omega-3 fatty acids.

Bioactive Compounds and Health Benefits

  1. Antioxidant Properties: Neutralize free radicals, protecting against chronic diseases.

  2. Anti-Inflammatory Effects: Modulate pathways, reducing inflammation risk.

  3. Cardiovascular Health: Improve lipid profiles, regulate blood pressure, support heart health.

  4. Cognitive Function: Enhance brain function, reduce cognitive decline risk.

Disease Treatment and Prevention

  1. Cancer: Anti-cancer properties, potential in prevention and treatment.

  2. Metabolic Disorders: Manage diabetes and obesity, influencing insulin sensitivity.

  3. Neurological Disorders: Potential neuroprotective effects, aiding symptom management.

Recommended Dietary Sources

  1. Fruits and Vegetables: Rich in bioactive compounds; diverse and colorful diets promote health.

  2. Fish and Nuts: Source of omega-3 fatty acids, supporting cardiovascular and cognitive health.

  3. Whole Grains: Provide fiber, B-vitamins, and antioxidants (examples: quinoa, oats, brown rice).

  4. Lean Proteins: Sources of protein, iron, zinc, and B-vitamins (examples: chicken, turkey, lean beef).

  5. Tea and Coffee: Contain polyphenols, catechins, and caffeine with health benefits.

6.3 Evaluation through Animal Models, Human Clinical Trials

  1. Animal Models: Assess safety, efficacy, mechanisms of action.

  2. Human Clinical Trials: Essential for evaluating functional foods' health impact, including phases I-IV.

Phases of Human Clinical Trials

  • Phase I: Focus on safety, dosage, adverse effects.

  • Phase II: Expands to larger groups for efficacy testing.

  • Phase III: Confirms efficacy in large populations, monitors side effects.

  • Phase IV: Post-marketing surveillance for long-term effects.

Example Studies in Human Clinical Trials

  1. Cardiometabolic Health: Evaluating functional beverages on cholesterol and blood pressure.

  2. Cognitive Function: Assessing nutraceuticals on memory and cognitive decline in elderly.

  3. Joint Health: Investigating functional food's efficacy in arthritis symptoms reduction.

Example Studies on Cinnamon

In-vitro Studies

  1. Sun et al. (2019): Procyanidin C1 enhances insulin sensitivity via AKT pathway activation.

  2. Azimian et al. (2023): Ceylon cinnamon water extract effects compared to metformin in HepG2 cells.

In-vivo Studies

  1. Liu et al. (2023): Cinnamon powder regulates glucose metabolism in diabetic mice.

  2. Adiga (2019): Cinnamomum zeylanicum extracts improve insulin sensitivity and metabolic risk factors.

  3. Fard et al. (2012): Swimming training and cinnamon increase GLUT4 and insulin receptor expression in diabetic rats.

Fruit & Vegetable Research Studies

In-vitro

  • Evaluate influence of fruit and vegetable extracts versus red meat on cancer cells.

In-vivo

  • Implement dietary interventions observing cancer incidence and tumor growth.

Human Trial

  • Conduct RCT on increased fruit and vegetable consumption effects on cancer development.

6.4 Identification of Appropriate Biomarkers

  • Definition: Measurable indicators reflecting biological processes or responses to treatments.

  • Function: Assess efficacy and safety; objective measures of biological responses.

Criteria for Selecting Biomarkers

  1. Relevance to health outcome.

  2. Sensitivity and specificity to induced changes.

  3. Feasibility of collection and analysis.

Types of Biomarkers

  1. Surrogate biomarkers (e.g., Hemoglobin A1c for blood sugar control).

  2. Response biomarkers (e.g., inflammatory markers).

  3. Predictive biomarkers (e.g., genetic markers for dietary response).

Example Biomarkers in FFN

  1. Inflammation Biomarkers: CRP, IL-6 indicating anti-inflammatory effects.

  2. Cardiometabolic Biomarkers: Cholesterol, blood pressure changes reflecting functional food impacts.

  3. Oxidative Stress Biomarkers: MDA, SOD indicating oxidative stress response.

  4. Gut Health Biomarkers: Microbial diversity, SCFAs reflecting prebiotics/probiotics impact.

6.5 Safety and Toxicity Issues in FFN

Safety Assessment Parameters

  1. Acute Toxicity: Evaluate immediate adverse effects post-consumption.

  2. Subchronic and Chronic Toxicity: Assess long-term exposure effects.

  3. Genotoxicity and Mutagenicity: Evaluate DNA impact for carcinogenic potential.

  4. Allergenicity: Identify potential allergic reactions using in vitro tests.

Regulatory Compliance

  • FDA and EFSA Guidelines: Adherence to safety regulations ensures consumer confidence.

  • GRAS Status: Demonstrates a history of safe use or scientific evidence of safety.

Case Studies on Safety Concerns

Case Study 1: Ephedra

  • Popular for purported weight loss effects but associated with significant cardiovascular risks.

  • Banned in 2004 due to adverse events including heart attacks and strokes.

Case Study 2: Melamine

  • Illegally added to infant formula causing serious health crises, leading to recalls.

7.0 Issues in Functional Food and Nutraceuticals

7.1 Food Fraud

  • Intentional substitution or misrepresentation of food products.

  • Examples: Mislabeling ingredients, dilution, false geographical claims.

  • Impact: Loss of consumer trust, health risks, financial losses.

7.2 Product Overclaim

  • Exaggerated claims about health benefits of nutraceuticals.

  • Examples: "Cures all diseases", guaranteed weight loss without effort.

  • Impact: Misinformation, legal consequences, credibility harm.

Regulatory Measures

  • Stricter regulations on claims, ensuring transparency and evidence-based marketing.

Actionable Recommendations

  • Enhanced regulatory oversight and consumer education on recognizing credible certifications.