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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000037516
Receipt No. R000042771
Scientific Title Effect of edible powder ingestion on Cognitive function and hormones.
Date of disclosure of the study information 2019/07/31
Last modified on 2019/10/11

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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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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