UMIN-CTR Clinical Trial

Public title

Effect of the Drink Containing Plant Extract on Fat Metabolism During Exercise (HR-2016-KO14)

Acronym

Effect of the Drink Containing Plant Extract on Fat Metabolism

Scientific Title

Effect of the Drink Containing Plant Extract on Fat Metabolism During Exercise (HR-2016-KO14)

Scientific Title:Acronym

Effect of the Drink Containing Plant Extract on Fat Metabolism

Region

Japan

Condition

N/A(healthy adults)

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

This study examines the effect of the drink containing plant extract on fat metabolism during exercise.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

[1]Fat oxidation during exercise (test period I, test period II)

Key secondary outcomes

*Secondary outcomes
[1]Energy expenditure during exercise (screening, test period I, test period II)
[2]Respiratory quotient during exercise (screening, test period I, test period II)
[3]Fasting energy expenditure (screening, test period I, test period II)
[4]Fasting fat oxidation (screening, test period I, test period II)
[5]Fasting respiratory quotient (screening, test period I, test period II)
[6]Blood examination (screening, test period I, test period II)
[7]Urine analysis (screening, test period I, test period II)

*Safety
[1]Respiratory gas examination except indexes of primary and secondary outcomes (screening, test period I, test period II)
[2]Blood examination (screening, test period I, test period II)
[3]Urine analysis (screening, test period I, test period II)
[4]Adverse event (each day during the test period)
[5]Diagnosis by doctors (each day during the test period)

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

[1]Oral intake of the test product (containing plant extract, 1 bottle in a day; 2 weeks)
[2]Observation
[3]Washout (2 weeks)
[4]Oral intake of the placebo product (not containing plant extract, 1 bottle in a day; 2 weeks)
[5]Observation

Interventions/Control_2

[1]Oral intake of the placebo product (not containing plant extract, 1 bottle in a day; 2 weeks)
[2]Observation
[3]Washout (2 weeks)
[4]Oral intake of the test product (containing plant extract, 1 bottle in a day; 2 weeks)
[5]Observation

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

20

years-old

<=

Age-upper limit

50

years-old

>

Gender

Male

Key inclusion criteria

[1]Healthy males aged 20-49 years
[2]Individuals whose BMIs are over 20 and under 25
[3]Individuals who are healthy and have no disease
[4]Individuals judged appropriate for the study by the principal
[5]Individuals who can come to the designated venue for this study and be inspected
[6]Individuals who are in the habit of walking or running and are capable of stopping these habits and conducting an exercise by ergometer
[7]Individuals whose written informed consent have been obtained

Key exclusion criteria

[1]Individuals using medical products
[2]Individuals who are sensitive to a test product
[3]Individuals who will plan to go long term business trip or trip (more than 6 consecutive days) during test period
[4]Individuals who are shift worker
[5]Individuals who are difficult to participate due to have a liver, kidney and heart disease, or disorder of respiration, endocrine, metabolism, nervous system, consciousness, or diabetes, or other diseases
[6]Individuals with serious anemia
[7]Individuals who excessively take alcohol (expressed in an amount of alcohol: over 30mg/day)
[8]Individuals who are a smoker
[9]Individuals who will be not capable of stopping to intake green tea, coffee and other beverage containing caffeine during the test period
[10]Individuals who participated or will participate in other clinical studies
[11]Individuals who have been medicated or operated in the past 2 months
[12]Individuals who had a habit to ingest health-promoting foods, foods for specified health uses, health foods, or supplements (individuals who will stop to ingesting these foods at the begging of the test can participate into the study)
[13]Individuals who have experience of bad feeling by blood sampling
[14]Individuals who donated blood over 200mL in the past 1 month or have a plan to donate blood over 200mL.
[15]Individuals who cannot intake test foods constantly during the test period
[16]Individuals who cannot record a dietary record (for 6 days)
[17]Individuals who deny to disclose past their own medical examination record
[18]Individuals who cannot agree current informed consent
[19]Individuals judged inappropriate for the study by the principal

Target sample size

22

Name of lead principal investigator

1st name	Takahiro
Middle name
Last name	Ono

Organization

Medical Corporation Wakei-kai Medics Hongo Clinic

Division name

Director

Zip code

113-0023

Address

2-2-6 Mukogaoka Bunkyo-ku Hongo Tokyo 113-0023, JAPAN

TEL

03-6801-9761

Email

info@tes-h.co.jp

Name of contact person

1st name	Ryoma
Middle name
Last name	Shimizu

Organization

TES Holdings Co. Ltd

Division name

Administrative Department of Clinical Trials

Zip code

110-0013

Address

6F University of Tokyo Entrepreneur Plaza 7-3-1 Hongo Bunkyo-ku Tokyo 113-0033, JAPAN

TEL

03-6801-8480

Homepage URL

Email

info@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

The Ethics Committee of the Oriental Ueno Detection Center

Address

Ueno Taito-ku Tokyo 110-0005, JAPAN

Tel

03-5816-0711

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

Date of disclosure of the study information

2016

Year

09

Month

24

Day

URL releasing protocol

N/A

Publication of results

Unpublished

URL related to results and publications

N/A

Number of participants that the trial has enrolled

22

Results

There was no significant difference in the primary outcome.

Results date posted

2019

Year

12

Month

25

Day

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Healthy males.

Participant flow

22 participants were enrolled in this study. One participant dropped out before starting to consume the test (or placebo) products. 21 participants who completed this study were incorporated into the analyses.

Adverse events

No adverse events related to the test products were reported.

Outcome measures

Fat oxidation during exercise.

Plan to share IPD

IPD sharing Plan description

Recruitment status

Completed

Date of protocol fixation

2016

Year

08

Month

31

Day

Date of IRB

2016

Year

08

Month

30

Day

Anticipated trial start date

2016

Year

09

Month

26

Day

Last follow-up date

2016

Year

11

Month

13

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2016

Year

09

Month

23

Day

Last modified on

2020

Year

01

Month

07

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027753