I7160001 Clinical food science

Hiroshima University Syllabus

Japanese

Academic Year 2025Year School/Graduate School School of Pharmaceutical Sciences Program of Pharmaceutical Sciences

Lecture Code I7160001 Subject Classification Specialized Education

Subject Name 食品臨床評価学

Subject Name
（Katakana）ショクヒンリンショウヒョウカガク

Subject Name in
English Clinical food science

Instructor NODA MASAFUMI,DANSHIITSOODOL NARANDALAI

Instructor
(Katakana) ノダ　マサフミ,ダンシーツオーダロ　ナランダライ

Campus Kasumi Semester/Term 4th-Year, First Semester, First Semester

Days, Periods, and Classrooms (1st) Weds9-10：霞R301講義室

Lesson Style Lecture Lesson Style
(More Details) Face-to-face, Online (simultaneous interactive)

PC slides with handout, statistical analysis training

Credits 2.0 Class Hours/Week 2 Language of Instruction B : Japanese／English

Course Level 3 : Undergraduate High-Intermediate

Course Area（Area） 27 : Health Sciences

Course Area（Discipline） 03 : Pharmaceutical Sciences

Eligible Students

Keywords clinical trial for functional materials, functional food, biostatistics

Special Subject for Teacher Education 　 Special Subject 　

Class Status
within Educational
Program
(Applicable only to targeted subjects for undergraduate students)
Criterion referenced
Evaluation
(Applicable only to targeted subjects for undergraduate students) Pharmaceutical Sciences
（Knowledge and Understanding）
・Knowledge and understanding of the biological maintenance system of homeostasis and the ability to adjust to the environment ●quality⑤
・Abilities・skills of citing speculated major diseases from aberration of clinical test values. ●quality ⑥

Medicinal Sciences
（Knowledge and Understanding）
・Knowledge of human and biological bodies.
（Abilities and Skills）
・Development of knowledge about human and biological bodies. (advance)

Class Objectives
/Class Outline This course aims to provide fundamental knowledge on the scientific evaluation methods of food functionality, covering study design and result analysis through concrete examples. Additionally, it focuses on developing applied skills required for a clinical trial specialist for functional foods.

Class Schedule Session 1: Orientation
Development of functional foods and clinical research
Session 2: Introduction to Food Clinical Evaluation I
History of pharmaceuticals and food
Session 3: Introduction to Food Clinical Evaluation II
Relevant regulations surrounding health foods
Current state of the health food market
Session 4: Introduction to Food Clinical Evaluation III
Issues related to health foods
Medical ethics
Session 5: Background of Ethical Guidelines Formulation I
Session 6: Background of Ethical Guidelines Formulation II
Session 7: Preparing a Research Protocol I
Clinical research design
Session 8: Preparing a Research Protocol II
Explanation of research protocols and informed consent documents using real-life examples
Session 9: Midterm Examination
Session 10: Fundamentals of Various Pathologies and Clinical Test Items I
Explanation of efficacy claims recognized under the Foods for Specified Health Uses (FOSHU) system
Session 11: Fundamentals of Various Pathologies and Clinical Test Items II
Explanation of various peptide hormones and biomarkers that have gained attention in recent years
Session 12: Targets for Drug Discovery and Functional Foods I
Session 13: Targets for Drug Discovery and Functional Foods II
Discussion over two sessions on the gut microbiota, an emerging research focus, and its correlation with diseases
Session 14: Academic Paper Writing I
Session 15: Academic Paper Writing II
Explanation of real-life product development cases over two sessions

(Session 16: Final Examination)

Text/Reference
Books,etc. nothing in particular

PC or AV used in
Class,etc. Text, Handouts, Microsoft Teams

(More Details) handout, PC slides

Learning techniques to be incorporated Discussions

Suggestions on
Preparation and
Review Lectures will be conducted using slides and handouts, so purchasing the reference materials is not required for attendance. However, students are encouraged to supplement their understanding with additional resources after the lectures.

Requirements This lecture is one of the lectures provided in “Training program for clinical trial specialist to evaluate functional foods

Grading Method Grading Criteria (Total: 100 points)
Class participation: 20 points
Midterm examination: 40 points
Final examination: 40 points
A minimum score of 60 points is required to pass the course.

Practical Experience

Summary of Practical Experience and Class Contents based on it

Message

Other This program provides following SBOs.
D-3-3 (1)〜(7)
E-2-1 (1)〜(3)
F-4-1 (1)

Please fill in the class improvement questionnaire which is carried out on all classes.
Instructors will reflect on your feedback and utilize the information for improving their teaching.

Academic Year	2025Year	School/Graduate School	School of Pharmaceutical Sciences Program of Pharmaceutical Sciences
Lecture Code	I7160001	Subject Classification	Specialized Education
Subject Name	食品臨床評価学
Subject Name （Katakana）	ショクヒンリンショウヒョウカガク
Subject Name in English	Clinical food science
Instructor	NODA MASAFUMI,DANSHIITSOODOL NARANDALAI
Instructor (Katakana)	ノダ　マサフミ,ダンシーツオーダロ　ナランダライ
Campus	Kasumi	Semester/Term	4th-Year, First Semester, First Semester
Days, Periods, and Classrooms	(1st) Weds9-10：霞R301講義室
Lesson Style	Lecture	Lesson Style (More Details)	Face-to-face, Online (simultaneous interactive)
PC slides with handout, statistical analysis training
Credits	2.0	Class Hours/Week	2	Language of Instruction	B : Japanese／English
Course Level	3 : Undergraduate High-Intermediate
Course Area（Area）	27 : Health Sciences
Course Area（Discipline）	03 : Pharmaceutical Sciences
Eligible Students
Keywords	clinical trial for functional materials, functional food, biostatistics
Special Subject for Teacher Education		Special Subject
Class Status within Educational Program (Applicable only to targeted subjects for undergraduate students)
Criterion referenced Evaluation (Applicable only to targeted subjects for undergraduate students)	Pharmaceutical Sciences （Knowledge and Understanding）・Knowledge and understanding of the biological maintenance system of homeostasis and the ability to adjust to the environment ●quality⑤ ・Abilities・skills of citing speculated major diseases from aberration of clinical test values. ●quality ⑥ Medicinal Sciences （Knowledge and Understanding）・Knowledge of human and biological bodies. （Abilities and Skills）・Development of knowledge about human and biological bodies. (advance)
Class Objectives /Class Outline	This course aims to provide fundamental knowledge on the scientific evaluation methods of food functionality, covering study design and result analysis through concrete examples. Additionally, it focuses on developing applied skills required for a clinical trial specialist for functional foods.
Class Schedule	Session 1: Orientation Development of functional foods and clinical research Session 2: Introduction to Food Clinical Evaluation I History of pharmaceuticals and food Session 3: Introduction to Food Clinical Evaluation II Relevant regulations surrounding health foods Current state of the health food market Session 4: Introduction to Food Clinical Evaluation III Issues related to health foods Medical ethics Session 5: Background of Ethical Guidelines Formulation I Session 6: Background of Ethical Guidelines Formulation II Session 7: Preparing a Research Protocol I Clinical research design Session 8: Preparing a Research Protocol II Explanation of research protocols and informed consent documents using real-life examples Session 9: Midterm Examination Session 10: Fundamentals of Various Pathologies and Clinical Test Items I Explanation of efficacy claims recognized under the Foods for Specified Health Uses (FOSHU) system Session 11: Fundamentals of Various Pathologies and Clinical Test Items II Explanation of various peptide hormones and biomarkers that have gained attention in recent years Session 12: Targets for Drug Discovery and Functional Foods I Session 13: Targets for Drug Discovery and Functional Foods II Discussion over two sessions on the gut microbiota, an emerging research focus, and its correlation with diseases Session 14: Academic Paper Writing I Session 15: Academic Paper Writing II Explanation of real-life product development cases over two sessions (Session 16: Final Examination)
Text/Reference Books,etc.	nothing in particular
PC or AV used in Class,etc.	Text, Handouts, Microsoft Teams
(More Details)	handout, PC slides
Learning techniques to be incorporated	Discussions
Suggestions on Preparation and Review	Lectures will be conducted using slides and handouts, so purchasing the reference materials is not required for attendance. However, students are encouraged to supplement their understanding with additional resources after the lectures.
Requirements	This lecture is one of the lectures provided in “Training program for clinical trial specialist to evaluate functional foods
Grading Method	Grading Criteria (Total: 100 points) Class participation: 20 points Midterm examination: 40 points Final examination: 40 points A minimum score of 60 points is required to pass the course.
Practical Experience
Summary of Practical Experience and Class Contents based on it
Message
Other	This program provides following SBOs. D-3-3 (1)〜(7) E-2-1 (1)〜(3) F-4-1 (1)
Please fill in the class improvement questionnaire which is carried out on all classes. Instructors will reflect on your feedback and utilize the information for improving their teaching.

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