UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037516 |
|---|---|
| Receipt number | 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 17:06:52 |
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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
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
t.tamura@tes-h.co.jp
Sponsor or person
Institute
TES Holdings Co., Ltd.
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042771
