UMIN-CTR Clinical Trial

Public title

Effect of a plant derived beverage on energy metabolism

Acronym

Effect of a plant derived beverage on energy metabolism

Scientific Title

Effect of a plant derived beverage on energy metabolism

Scientific Title:Acronym

Effect of a plant derived beverage on energy metabolism

Region

Japan

Condition

Healthy adults

Classification by specialty

Not applicable

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To investigate the effect of a plant derived beverage on energy metabolism

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Medical examination regarding energy expenditure including lipid and carbohydrate prior to intervention and at 4 weeks consumption

Key secondary outcomes

Analysis of blood and urine

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 beverage (product code: P0001) 4 weeks consumption > wash out 4 weeks > test beverage (product code: A0001) 4 weeks consumption

Interventions/Control_2

Test beverage (product code: A0001) 4 weeks consumption > wash out 4 weeks > control beverage (product code: P0001) 4 weeks 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

30

years-old

<=

Age-upper limit

60

years-old

>

Gender

Male

Key inclusion criteria

(1)Subjects who have given written informed consent prior to start of study.
(2)Male workers at Kao Corporation.
(3)Age>=30 and <60 years
(4)BMI>=23 and <30

Key exclusion criteria

(1)Subjects who take a medicine.
(2)Subjects who have a history of heart disease.
(3)Subjects who have a history or signs of a cerebrovascular disease.
(4)Subjects having a liver, kidney, or heart disease, cardiovascular disease, respiratory disorder, endocrine disorder, metabolic disorder, organ disorder, gout, rheumatism, autoimmune disease, allergy disease, mental disorder, cancer, infection disease, or other diseases.
(5)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 current study.
(6)Subjects who have severe anemia (Hb <=7g/dL).
(7)Subjects who have allergic reaction to food.
(8)Subjects who have sensitivity to control or test beverage.
(9)Subjects who are planned to participate in other clinical study during current study.
(10)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	Noriko
Middle name
Last name	Osaki

Organization

Kao Corporation

Division name

Health Care Food Research Laboratories

Zip code

131-8501

Address

2-1-3, Bunka, Sumida-ku, Tokyo, 131-8501, Japan

TEL

03-5630-7224

Email

osaki.noriko@kao.co.jp

Name of contact person

1st name	Shun
Middle name
Last name	Katada

Organization

Kao Corporation

Division name

Health Care Food Research Laboratories

Zip code

131-8501

Address

2-1-3, Bunka, Sumida-ku, Tokyo, 131-8501, Japan

TEL

03-5630-7266

Homepage URL

Email

katada.shun@kao.co.jp

Institute

Kao Corporation

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

Human Research Ethics Committee, Kao Corporation

Address

2-1-3, Bunka, Sumida-ku, Tokyo, 131-8501, Japan

Tel

03-5630-9220

Email

morisaki.naoko@kao.com

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

花王株式会社ヘルスケア食品研究所（東京都）

Date of disclosure of the study information

2015

Year

10

Month

26

Day

URL releasing protocol

Unpublished due to the protocol including the intellectual property rights

Publication of results

Published

URL related to results and publications

https://www.mdpi.com/2072-6643/10/4/525/htm

Number of participants that the trial has enrolled

15

Results

Significant difference in the primary outcome between the groups

Results date posted

2020

Year

02

Month

18

Day

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

healthy male subjects

Participant flow

Fifteen subjects completed the trial and were analyzed.

Adverse events

None associated with the test beverage consumption

Outcome measures

Medical examination regarding energy expenditure including lipid and carbohydrate prior to intervention and at 4 weeks consumption

Plan to share IPD

IPD sharing Plan description

Recruitment status

Main results already published

Date of protocol fixation

2015

Year

10

Month

27

Day

Date of IRB

2015

Year

10

Month

27

Day

Anticipated trial start date

2015

Year

10

Month

29

Day

Last follow-up date

2016

Year

12

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2015

Year

10

Month

26

Day

Last modified on

2020

Year

02

Month

18

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022544