UMIN-CTR Clinical Trial

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

Healthy adults

Classification by specialty

Not applicable

Adult

Classification by malignancy

Others

Genomic information

NO

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

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.

Study type

Interventional

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

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

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

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

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

Institute

TES Holdings Co., Ltd.

Institute

Department

Personal name

Organization

Kao Corporation

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

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

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

うえのあさがおクリニック（東京都）

Date of disclosure of the study information

2019

Year

07

Month

31

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related 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