UMIN-CTR Clinical Trial

Basic information
Public title	Effect of Daily Ingestion of Apple on Improving Minor Ailments: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study
Acronym	Beneficial Effect of Daily Ingestion of Apple on Improving Minor Ailments
Scientific Title	Effect of Daily Ingestion of Apple on Improving Minor Ailments: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study
Scientific Title:Acronym	Beneficial Effect of Daily Ingestion of Apple on Improving Minor Ailments
Region	Japan

Condition
Condition	Healthy adults
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To prove improving minor ailments and safety associated with 2 weeks daily ingestion of apple, in a double-blind, placebo-controlled, parallel group comparison study.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	VAS questionnaire on fatigue at 2 weeks after beginning the intake of test food.
Key secondary outcomes	Intestinal flora, heart rate variability, electroencephalogram during sleeping, sleeping record, survey on subjects' sleeping and mental and physical conditions, urinary metabolites, urinary 8OHdG.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification	YES
Dynamic allocation	NO
Institution consideration
Blocking	YES
Concealment	No need to know

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Daily ingestion 100 g of dried apple A for 2 weeks.
Interventions/Control_2	Daily ingestion 100 g of dried apple B for 2 weeks.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	65 years-old >
Gender	Male and Female
Key inclusion criteria	1. Subjects who fully understand significance, content and purpose of this study and who agree to participate in this study with a written informed consent. 2. Subjects with relatively low score for VAS questionnaire on fatigue.
Key exclusion criteria	1. Subjects who are under treatment or medication for schizophrenia, depression, mania, nervous disorder or chronic fatigue syndrome. 2. Subjects with serious cerebrovascular, cardiac, hepatic, renal, gastrointestinal or affected with infectious diseases which is required to report to the authorities. 3. Subjects who have a major surgical history such as gastrectomy, gastrorrhaphy, enterectomy or other serious gastrointestinal surgeries. 4. Subjects with unusually high and/or low blood pressure, abnormal physical data and/or abnormal hematological data. 5. Subjects with severe anemia. 6. Pre- or post-menopausal women complaining of obvious physical changes. 7. Subjects who are at risk of having allergic reactions to drugs, foods (especially birch pollen, apples, peaches, pears, cherries, strawberries, plums and apricots). 8. Subjects who eat apples frequently. 9. Subjects who regularly take health foods and/or supplements containing polyphenols. 10. Subjects who regularly take foods fortified with oligosaccharides and/or dietary fiber, yogurt, cultured milk drink, and natto. 11. Subjects who took antibacterial drugs within 12 weeks before the start of ingestion. 12. Heavy smokers, alcohol addicts or subjects with irregular lifestyle. 13. Subjects who donated either 400 ml whole blood within 16 weeks (women), 12 weeks (men), 200 ml whole blood within 4 weeks, or blood components within 2 weeks, prior to the current study. 14. Pregnant or lactating women or women who expect to be pregnant during this study. 15. Subjects who currently participate in other clinical trials, or participated within the last 4 weeks prior to the current study. 16. Subjects determined to be ineligible by the principal investigator.
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Jun Middle name Last name NISHIHIRA
Organization	Hokkaido Information University
Division name	Department of Medical Management and Informatics
Zip code	069-8585
Address	59-2, Nishi-nopporo, Ebetsu, Hokkaido, Japan
TEL	011-385-4411
Email	nishihira@do-johodai.ac.jp

Public contact
Name of contact person	1st name Naoyuki Middle name Last name HONMA
Organization	Hokkaido Information University
Division name	Health Information Science Center
Zip code	069-8585
Address	59-2, Nishi-nopporo, Ebetsu, Hokkaido, Japan
TEL	011-385-4430
Homepage URL
Email	hisc-acad.res@s.do-johodai.ac.jp

Sponsor
Institute	Hokkaido Information University
Institute
Department

Funding Source
Organization	NARO Bio-oriented Technology Research Advancement Institution
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	The ethics committee of Hokkaido Information University
Address	59-2, Nishi-nopporo, Ebetsu, Hokkaido, 069-8585, Japan
Tel	011-385-4411
Email	soumu@do-johodai.ac.jp

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	北海道情報大学　保健センター（北海道）

Other administrative information
Date of disclosure of the study information	2021 Year 01 Month 22 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2020 Year 11 Month 25 Day
Date of IRB	2020 Year 11 Month 25 Day
Anticipated trial start date	2021 Year 02 Month 12 Day
Last follow-up date	2021 Year 03 Month 19 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2021 Year 01 Month 22 Day
Last modified on	2021 Year 10 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049174