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Clinical Trials for Foods and Food Products (Human Clinical Study )

Evaluation of the efficacy of foods and food products in human clinical study

The efficacy of foods and food product must be evaluated in human clinical trials to apply for TOKUHO, which is a label for foods for specified health use, and submit the notification of Foods with Functional Claims.
Based on our extensive experiences, we propose required protocols (condition of feeding, condition of patients, number od patients, outcome, and more).

Evaluation of the safety of foods and food products in human clinical study (long-term feeding/overfeeding)

The safety of foods and food product must be evaluated in human clinical trials to apply for TOKUHO.
Also, to evaluate and explain the safety of the foods with functional claims and other food products is one of the roles that food company takes.
We consult on food trials for applying for TOKUHO, necessity of conduction of safety research, and more.
We have been entrusted with around 320 the safety researches since 2001

Cases of clinical trials ・ human clinical studies

Knee Joint
Testing used biomarkers and subjective data in clinical trials, and more
Fatigue ・ Stress ・ Sleep
Testing used biomarkers, EEG (electroencephalogram) , and subjective data in clinical trials, and more
Immune Function
Testing of s-IgA secretion rate, neutrophils, activation of natural killer cells, and more
Metabolic syndrome
① Cholesterol level (Testing designed for patients who have high total cholesterol level or high low-density lipoprotein level)
② Blood glucose level (Testing designed for patients who have a high blood glucose level when fasting or the rapid increase in a blood glucose level after eating)
③ Blood pressure (Testing designed for patients with hypertension )
④ BMI ・ Body fat (Testing designated for patients with high body fat percentage or visceral fat area scaled by BMI, abdominal circumference, the computed tomography, the impedance method)
⑤ Neutral fat level (Testing designed for patients who have a high neutral fat level when fasting or the rapid increase in a neutral fat level after eating)
Skin
① Testing such as moisture ( amount of water, transepidermal water loss), skin color, skin elasticity (viscoelasticity), blemish, wrinkles, pore, skin image analysis, acne, hair, the usage of subjective data
② Patch safety Testing(light irradiated irritation Testing, allergic inflammation, and more)
③ UV protection Testing (measurements of SPF and UVA on human skin, and more)
Prevention of Infectious Diseases
Testing that evaluate the efficacy of prevention of upper respiratory tract infection designated for patients who easily get cold, and other testing
Eye function
Testing that evaluate the effect in ameliorating asthenopia caused by Visual Display Terminals syndrome, Testing that evaluate the effect in ameliorating dry eyes, and more
Cognitive function
Testing applied higher brain function evaluation, Electroencephalography (EEG) measurements testing, and more
Antiallergy
Testing in pollinosis exposure to antigen in an environmental exposure chamber, Testing to assess the value of symptom relies for perennial allergic rhinitis or atopic dermatitis, and more
Uric acid
Testing designated for patients with high uric acid level, and more
Blood circulation improvement ・ Oversensitivity to cold
Laser Doppler flowmetry, Thermography testing, and more
Swelling reduction
Testing designated for patients with leg swelling or get swollen easily, and more
Constipation improvement
Testing designated for patients with constipation to assess the improvement of intestinal environment, intestinal flora testing, and more
Menopause symptoms
Testing designated for female patients have subjective perimenopause symptom, and more
Osteoporosis prevention
Testing designated for female patients during the menopause to assess the effectiveness for maintenance of bone density using biomarker or DXA method, and more
Dysuria
Testing to assess the effectiveness with I-PSS, QOL score, OABSS, and more
Others
Liver function, Antioxidant, the GI level measurement, Blood coagulation / fibrinogenolysis system, Anemia, PMS, Cramps, Pylori, Body order, Gum disease, Cavity prevention, Oral bacteria testing, and more

For detailed documents, any inquiries or comments about Clinical Trials for Foods and Food Products (Human Clinical Study ) , please contact us via the inquiry form below.

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