UMIN-CTR Clinical Trial

Basic information
Public title	Effect of edible powder ingestion on postprandial blood parameters.
Acronym	Effect of edible powder ingestion on postprandial blood parameters.
Scientific Title	Effect of edible powder ingestion on Cognitive function and hormones.
Scientific Title:Acronym	Effect of edible powder ingestion on postprandial blood parameters.
Region	Japan

Condition
Condition	Healthy adults
Classification by specialty	Not applicable Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The aim of this study is to compare the effects of edible powder containing diets with control diet on postprandial blood parameters in healthy adults.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Blood parameters at 60, 120, and 240 min after single ingestion of edible powder containing diets or control diet.
Key secondary outcomes	Cognitive function, subjective assessment, etc., after single ingestion of edible powder containing diets or control diet.

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	Control diet consumption > wash out (more than 5 days) > test diet consumption
Interventions/Control_2	Test diet consumption > wash out (more than 5 days) > Control diet consumption
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	50 years-old <=
Age-upper limit	69 years-old >=
Gender	Male
Key inclusion criteria	(1)Age>=50 and <=69years (2)Day workers (3)Subjects who sleep at least five hours per day usually (4)Subjects who can take a test using personal computer (5)Subjects who have given written informed consent prior to start of study
Key exclusion criteria	(1)Subjects who have a history or signs of a neurodegenerative disorder or cerebrovascular disease or cardiovascular disease or thyroid disease (2)Subjects having a liver, kidney or respiratory disease, endocrine disorder, metabolic disorder, organ disorder, autoimmune disease, allergy disease, mental disorder, cancer, diabetes, infection disease, or other diseases (3)Subjects who take a sleeping drug, antipsychotic drug, anti-anxiety drug, antidepressant, antidiabetic drug or antihyperlipidemic drug (4)BMI>=30 (5)Subjects who usually take a functional foods or supplements that affects results (6)Heavy drinker (7)Subjects who have donated over 200 mL of blood within the last one month prior to the current study or over 400 mL of blood within the last three months prior to the study (8)Subjects who have severe anemia (Hb <=7g/dL) (9)Subjects who have been to get sick by collecting venous blood (10)Subjects who have allergic reaction to control or test food (11)Subjects who can't eat served control or test food all (12)Subjects who are planned to participate in other clinical study during current study (13) Subjects who can't keep eating and exercise habits during study (14)Subjects who are judged to be inappropriate for the study by the medical doctor or investigator for other reason
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Takahiro Middle name Last name Ono
Organization	Ueno-Asagao Clinic
Division name	Head
Zip code	110-0015
Address	Kairaku Building 6F, 2-7-5, Higashiueno, Taito-ku, Tokyo, 110-0015, Japan
TEL	03-6240-1162
Email	info@ueno-asagao.clinc

Public contact
Name of contact person	1st name Tamura Middle name Last name Toshiyasu
Organization	TES Holdings Co. Ltd
Division name	Department of Development for Clinical Trials
Zip code	110-0015
Address	Kairaku Building 6F, 2-7-5, Higashiueno, Taito-ku, Tokyo, 110-0015, Japan
TEL	03-6801-8480
Homepage URL
Email	t.tamura@tes-h.co.jp

Sponsor
Institute	TES Holdings Co., Ltd.
Institute
Department

Funding Source
Organization	Kao Corporation
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Ueno-Asagao Clinic Ethical Review Committee
Address	Kairaku Building 6F, 2-7-5, Higashiueno, Taito-ku, Tokyo, 110-0015, Japan
Tel	03-6240-1162
Email	jimukyoku@tes-h.co.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	うえのあさがおクリニック（東京都）

Other administrative information
Date of disclosure of the study information	2019 Year 07 Month 31 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	2019 Year 07 Month 31 Day
Date of IRB	2019 Year 07 Month 31 Day
Anticipated trial start date	2019 Year 08 Month 01 Day
Last follow-up date	2019 Year 10 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2019 Year 07 Month 29 Day
Last modified on	2019 Year 10 Month 11 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042771