Efficacy Test
As per Taiwan FDA requests, health foods that claim functions as below should obtain approval of Health Food Registration before importing, manufacturing, or launching:
- Blood lipid regulation
- Blood glucose regulation
- Immune modulation
- Liver function protection
- Gastrointestinal function improvement
- Reduction of body fat accumulation
- Bone health
- Dental health
- Anti-aging
- Anti-fatigue
- Assist in regulating blood pressure
- Assist in modulating allergy constitution
- Promotion of iron availability
Medgaea provides efficacy evaluation tests for Health Foods registration. According to the function design of the food product, we also deliver pilot studies for formula screening and dose range finding for our clients to reduce the cost and risk of new product development. Welcome to contact us.
Evaluation Method of Hepatoprotective Effect of Health Food
- Method
1. CCl4-induced liver damage model
2. APAP-induced liver damage model
3. TAA-induced liver fibrosis model
4. Alcohol-induced fatty liver disease model
5. High fat diet-induced nonalcoholic fatty liver disease model
- Item
Test items are different depending on the animal model:
1. Plasma or serum: AST, ALT, TG, TC, etc
2. Liver: glutathione, glutathione peroxidase, superoxide dismutase, catalase, TG, TC, glutathione reductase, glutathione S-transferase, collagen, liver fibrosis markers, etc
3. Pathological examination
Blood Lipid Regulation
- Guideline
Evaluation Method of Blood Lipid Regulation Effect of Health Food
- Test system
Male hamsters
- Method
1. High fat diet-induced hyperlipidemia model (induction in advance)
2 .High fat diet-induced hyperlipidemia model (induction and treatment at the same time)
- Item
Serum TG, TC, LDL-C, HDL-C, fecal lipids, liver lipids, etc.
Immune Modulation
- Guideline
Evaluation Method of Immuno-modulatory Effect of Health Food
- Test system
Male Balb/c mice
- Method
1. Non-specific immune response
2. OVA-specific immune response
- Item
Immune cell proliferation ability, natural killer cell activity, phagocytic cell activity, cytokine analysis, serum antibody analysis, cell surface marker analysis of spleen lymphocyte, etc.
Blood Glucose Regulation
- Guideline
Evaluation Method of Blood Glucose Regulation Effect of Health Food
- Test system
Male db/db mice
- Method
spontaneously hyperglycemia db/db mice
- Item
Fasting and postprandial blood glucose, glucose tolerance test, fasting and postprandial plasma insulin, urine glucose, etc
Gastrointestinal Function Improvement
- Guideline
Evaluation Method of Gastrointestinal Function Improvement Effect of Health Food
- Test system
SD or Wistar rats
- Method
To evaluate whether the test article has one of the following four GI functions through different animal models:
1. Improve digestion and absorption
2. Improve intestinal microbiota
3. Improve gastrointestinal motility
4. Contribute to the protection of gastric mucosa
- Item
1. Improve digestion and absorption: body weight, digestibility, enzyme activity
2. Improve intestinal microbiota: Bifidobacterium, Clostridium perfringens
3. Improve gastrointestinal motility: gastrointestinal motility (activated carbon), gastric mucosal protection, observation of the dry weight, grain number, moisture, and shape of feces
4. Contribute to the protection of gastric mucosa:
(1) in vitro: survival rate of rat gastric mucosal cells
(2) in vivo: determination of gastric acid secretion in rats (Shay’s ulcer method)
Bone Health Protection
- Guideline
Evaluation Method of Bone Health Protection Effect of Health Food
- Test system
SD or Wistar rats
- Method
1. Growing animal model
2. Ovariectomized (OVX) animal model
- Item
Body weight, body length, femoral length or femoral plus tibia length, and at least 2 of the following 5 indexes: bone density, determination of trabecular bone, assessment of trabecular mineral apposition rate (MAR), biomechanical analysis, and metabolic biochemical indexes of osteoblast (OB) and osteoclast (OC).
Anti-fatigue Effect
- Guideline
Evaluation Method of Anti-fatigue Effect of Health Food (Exercise-induced Fatigue)
- Subject
Healthy adults over 20 years old and have similar biological age
- Method
Randomized double-blind crossover study design
- Item
1. Physical performance index: anaerobic exercise, maximum aerobic exercise, endurance, muscle strength, muscle endurance, muscle endurance strength, and power.
2. Mechanism index: endocrine pressure index of physiological pressure, muscle tissue damage index, muscle tissue energy storage index.
Anti-aging Effect
- Guideline
Evaluation Method of Anti-aging Effect of Health Food
- Test system
Animal models of senescence:
1. aging rats or mice
2. long-term experiment using young rats or mice
3. senescence accelerate mouse (SAM)
4. drug-induced aging animal:
(1) D-galactose induced senescence model
(2) Parkinson’s disease animal model (PD)
(3) Alzheimer’s disease animal model (AD)
- Method
Select an appropriate animal model of senescence for further experiment.
- Item
Test items are different depending on the animal model:
1. Bioactive index of brain aging
2. Bioactive index of liver, cardiovascular, blood, or kidney aging
3. Anti-oxidant index
Reduction of Body Fat Accumulation
- Guideline
Evaluation Method of Body Fat Accumulation Reducing Effect of Health Food
- Test system
Male SD rats
- Method
1. High energy diet-induced obesity model (induction in advance)
2. High energy diet-induced obesity model (induction and treatment at the same time)
- Item
Body weight, fat percentage, serum TC, free fatty acid, LDL-C, HDL-C, liver lipids, blood glucose, liver function index, kidney function index, etc.
Assist in Modulating Allergy Constitution
- Guideline
Evaluation Method of Allergy Constitution Modulating Effect of Health Food
- Test system
Balb/c or B6 mice
- Method
1. Allergic model induced by intraperitoneal injection of allergen
2. Respiratory allergy model
3. allergic rhinitis model
- Item
serum antibody analysis, Immune cell proliferation ability, cytokine analysis, pulmonary function measurement or other allergy-related index, natural killer cell activity, phagocytic cell activity, etc.
Assist in Regulating Blood Pressure
- Guideline
Evaluation Method of Blood Pressure Regulating Effect of Health Food
- Subject
Adults over 20 years old who have been diagnosed with higher blood pressure or mild hypertension by a physician and are not taking medication to control blood pressure
- Method
Double-blind, randomized, parallel-controlled
- Item
Blood pressure, safety monitoring