functional foods exam 1

Functional Food (General Form)

Must be an actual food consumed in normal dietary amounts (not a pill or capsule).

Functional Food (General Purpose)

Provides physiological health benefits beyond basic nutrition.

Functional Food (US / FDA Legal Status)

Has no formal statutory definition under US law; regulated as conventional food.

Functional Food (European / FuFoSE Definition)

Beneficially affects target bodily functions beyond nutrition to lower disease risk.

Functional Food (Health Canada Definition)

Similar to conventional food, consumed in normal diet, with demonstrated health benefits.

Nutraceutical (Origin of Term)

Coined by Stephen DeFelice in 1989 ("nutrition" + "pharmaceutical").

Nutraceutical (Form & Function)

Isolated bioactive food components sold in dosage forms (pills/liquids) for medical benefits.

Dietary Supplement (Form)

Dosage forms (pills, capsules, powders, liquids) taken to supplement the diet.

Dietary Supplement (Intended Purpose)

Maintains normal health and prevents nutrient deficiencies (cannot treat or cure disease).

Functional Food vs. Nutraceutical vs. Supplement (Form Distinction)

Functional foods are conventional foods; nutraceuticals and supplements are dosage forms (pills/capsules).

Bioactive Compound / Phytochemical

Non-nutrient plant/animal constituents present in small amounts that exert biological activity

Bioavailability

The fraction of an ingested compound that is absorbed and reaches systemic circulation.

Bioefficacy

The ability of an absorbed compound to produce a specific biological response in tissues.

Biomarker (Definition & Examples)

Measurable biological parameter (e.g., blood pressure, blood glucose, CRP) monitoring health outcomes.

Chronic Disease (CDC Definition)

Non-contagious medical condition lasting $\ge 1$ year requiring ongoing medical care.

Modifiable Risk Factors

Changeable behaviors influencing disease risk (poor diet, inactivity, smoking, obesity).

Non-Modifiable Risk Factors

Unchangeable traits influencing disease risk (age, sex, genetics, family history, race).

Free Radical

Unstable atom/molecule with an unpaired electron (O2*-) that damages cells.

Reactive Oxygen Species (ROS / RNS)

Chemically reactive oxygen/nitrogen molecules that induce cellular oxidative stress.

Oxidative Stress

Imbalance between excess free radical production and inadequate antioxidant defenses.

Antioxidant (Mechanism of Action)

Neutralizes free radicals by donating electrons without becoming unstable.

Capsinoids (Botanical Source)

Non-pungent compounds extracted from CH-19 Sweet pepper fruit (Capsicum annuum L.)

Capsinoids (Extracted Active Components)

Capsiate, dihydrocapsiate, and nordihydrocapsiate in a 63:27:10 ratio

Capsinoid vs. Capsaicin (Chemical Structure)

Capsinoids have an ester bond; capsaicin has an amide bond

Capsinoid Non-Pungency (Mechanism)

Hydrolyzed in oral mucosa before activating oral TRPV1 heat receptors

Capsinoids Study (Design & Duration)

12-week, randomized, double-blind, placebo-controlled trial

Capsinoids Study (Dose & Diet)

6 mg/day oral capsinoids alongside a 300–600 kcal/day calorie deficit

Capsinoids Study (Participants & BMI)

80 overweight/obese adults (40 men, 40 women) with BMI 25-35 kg/m²

Capsinoids Study (Capsule Dosing Schedule)

6 softgels daily (3 before breakfast, 3 before dinner) containing $1\text{ mg}$ capsinoids each

Capsinoids Study (Color Masking Additive)

0.015% marigold oil added to both active and placebo capsules to match yellow color

Capsinoids Study (Body Weight Outcome)

-0.92 kg (capsinoids) vs. -0.49 kg (placebo); NOT statistically significant (p=0.86)

Capsinoids Study (Total Body Fat Outcome)

DXA total body fat change did not differ significantly between groups (p=0.67)

Capsinoids Study (Abdominal Adiposity Outcome)

Abdominal fat decreased significantly more in capsinoid group (-1.11%) vs. placebo (-0.18%, p=0.049)

Capsinoids Study (Lean Mass Outcome)

-156g (capsinoids) vs. -41g (placebo; p=0.74), suggesting lean-mass sparing

Capsinoids Study (Resting Energy Expenditure- REE)

trended 54 kcal/day higher capsinoid men at week 12 (non-significant, p=0.19)

Capsinoids Study (Fat Oxidation Outcome)

Borderline significantly higher at week 12 in capsinoid group (+21.0 mg/min, p=0.06)

Capsinoids Study (Plasma Lipids Outcome)

No significant changes in cholesterol, HDL, LDL, or triglycerides

Capsinoids Study (Feasibility for Weight Loss)

Would take 1 to 2 years to achieve medically significant weight loss (5-10%)

Capsinoids (Prior Animal Model Mechanisms)

Activates gut TRPV1, increases sympathetic activity, up-regulates UCPs, and stimulates thermogenesis

Pharmacogenetics: TRPV1 Val585Ile Variant

Val/Val and Val/Ile carriers lost double the abdominal fat vs. Ile/Ile carriers (p=0.0008)

Pharmacogenetics: UCP2 -866 G/A Variant

Promoter SNP in uncoupling protein 2 correlated with abdominal fat loss response (p=0.02)

FD&C Act of 1938

Authorizes FDA safety/labeling oversight; regulates functional foods as conventional foods

Nutrition Labeling and Education Act (NLEA of 1990)

Federal law authorizing health claims and nutrient content claims on food labels

Significant Scientific Agreement (SSA) Standard

Highest FDA evidentiary standard requiring broad consensus among qualified scientific experts

Authorized NLEA Health Claim (Osteoporosis)

Links Calcium and Vitamin D to reduced risk of Osteoporosis

Authorized NLEA Health Claim (Hypertension)

Links low Sodium intake to reduced risk of Hypertension

Authorized NLEA Health Claim (Heart Disease & Fiber/Sterols)

Links soluble fiber (oats/psyllium) and plant sterols to reduced Coronary Heart Disease risk

Authorized NLEA Health Claim (Neural Tube Defects)

Links adequate Folic Acid intake in pregnancy to reduced risk of Neural Tube Defects

Nutrient Content Claims

Characterizes nutrient levels using standardized terms like “low”, “high”, “free” or “lite”

"Healthy" Label Claim

Implied claim requiring food to meet strict FDA limits on fat, sat fat, cholesterol, and sodium

FDA Modernization Act (FDAMA of 1997)

Permits health claims based on authoritative statements from official scientific bodies (e.g., NIH)

FDAMA Authoritative Health Claims Limitation

Cannot be used on dietary supplement labels (conventional foods only)

Qualified Health Claims (Interim 2003)

Permitted when evidence is emerging (below SSA); requires explicit qualifying disclaimer text

Dietary Supplement Health and Education Act (DSHEA of 1994)

Regulates supplements as a special food category and governs structure/function claims

Structure/Function Claims

Describes role in supporting normal body structure/function; MUST NEVER mention a disease

Mandatory DSHEA Disclaimer

"This statement has not been evaluated by the FDA... not intended to diagnose, treat, cure, or prevent disease."

Conventional Food Structure/Function Exception

Conventional functional foods making structure/function claims do NOT require the DSHEA disclaimer

FOSHU (Full Name & Year)

Foods for Specified Health Uses; established in Japan in 1991 (world's first system)

Three FOSHU Approving Government Bodies

Consumer Affairs Agency (CAA), Food Safety Commission, and Council on Pharmaceutical Affairs

FOSHU Scientific Testing Requirement

Demands brand new, original human clinical trials on the final finished food product

FOSHU Cost and Timeline

Extremely expensive ($1–$2 million) and takes several years per product approval

FFC (Full Name & Year)

Foods with Function Claims; introduced in Japan in 2015

FFC Approval Process

Notification-based system requiring existing literature/systematic reviews submitted to the CAA

FFC Final Product Testing

No original clinical trials on the final product are required

FFC Manufacturer Responsibility

Manufacturers bear 100% full legal responsibility for safety, efficacy, and claim accuracy

FFC Scope Advantage over FOSHU

Allows wellness/symptom claims not permitted in FOSHU (e.g., fatigue reduction, stress relief)

FFC Market Impact & Public Risk

Sales surpassed FOSHU quickly, but lack of final-product testing led to safety incidents

Functional Food Category 1: Conventional Foods

Unmodified whole foods naturally rich in bioactives (e.g., garlic, blueberries, oats)

Functional Food Category 2: Modified Foods

Foods fortified or enriched with extra nutrients (e.g., calcium-fortified orange juice)

Functional Food Category 3: Enhanced Commodities

Foods enhanced via altered feed or growing conditions (e.g., Omega-3 enriched eggs)

Functional Food Category 4: Food Ingredients

Isolated, purified preparations of active compounds (e.g., soy isoflavones, prebiotics)

Transformation Approach: Elimination

Removing a harmful or allergenic component (e.g., protein removal in hypoallergenic rice)

Transformation Approach: Dose Manipulation

Increasing concentration of an existing natural nutrient to therapeutic levels

Transformation Approach: Adding Components

Incorporating a beneficial non-native ingredient (e.g., prebiotic fructans in bread)

Transformation Approach: Replacement

Substituting a macronutrient with a healthier alternative (e.g., replacing sat fat with fiber)

Transformation Approach: Improving Functionality

Enhancing bioavailability or stability of a functional ingredient

Steps 1–3 of Functional Food Market Development

Establish GOAL; FIND bioactive compound (BC); Establish DOSAGE

Steps 4–6 of Functional Food Market Development

Establish mechanisms; Find biomarkers; Create food vehicle/matrix

Steps 7–9 of Functional Food Market Development

Pre-clinical studies; Human clinical trials; Create functional label

Steps 10–12 of Functional Food Market Development

Market to EDUCATE; Epidemiological studies; Submit for agency approval

Steps 13–15 of Functional Food Market Development

Release product to market; After-market research; Final establishment

Plant Sterols/Stanols (Early Commercial Example)

Added to margarines (e.g., Benecol) as an early functional food innovation

Plant Sterols/Stanols (Mechanism 1: Intestines)

Displaces cholesterol in digestive micelles, reducing LDL absorption by 30%–50%

Plant Sterols/Stanols (Mechanism 2: Gene Expression)

Modifies enterocyte transporters to increase trans-intestinal cholesterol excretion

Lycopene

Red carotenoid antioxidant in tomatoes reducing risk of prostate cancer and CVD

Lutein & Zeaxanthin

Carotenoids in dark greens and corn that concentrate in the macula for eye health

Beta-Carotene

Orange pigment in carrots/sweet potatoes acting as Vitamin A precursor and antioxidant

Anthocyanins & Pterostilbene

Blueberry polyphenols supporting vascular/brain health; operates via AMPK/mTOR pathway

Glucosinolates & Isothiocyanates

Organosulfurs in cruciferous vegetables (broccoli/kale) enhancing liver detoxification

Garlic Organosulfur Compounds

Low-molecular-weight thiols in garlic providing antimicrobial and cardioprotective effects

Gingerols

Active principles in ginger providing anti-nausea and anti-inflammatory benefits

Fenugreek Bioactives (4-Hydroxyisoleucine & Galactomannan)

Active principles in fenugreek seed responsible for anti-diabetic glycemic control

Insoluble Dietary Fiber

Cellulose/wheat bran that increases fecal bulk and maintains GI bowel regularity

Soluble Fiber & Beta-Glucans

Viscous fibers in oats/barley that lower LDL cholesterol and slow gastric emptying

Probiotics

Live microorganisms (Lactobacillus, Bifidobacteria) conferring gut and immune health

Prebiotics

Non-digestible fermentable fibers (Inulin, FOS) selectively feeding beneficial gut bacteria

Synbiotics

Products combining both probiotics and prebiotics in a single formulation

Vitamin C (Biological Roles & Deficiency)

Collagen synthesis cofactor and antioxidant; deficiency causes scurvy

Vitamin A (Biological Role & Deficiency)

Essential component of visual pigment rhodopsin; deficiency causes night blindness

Vitamin K (Biological Roles)

Required for gamma-carboxylation of blood clotting factors and bone mineralization