UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000036296
Receipt number R000041351
Scientific Title A study about feeling of fatigue reduction effect of food containing algae
Date of disclosure of the study information 2020/03/29
Last modified on 2021/08/24 23:45:58

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Basic information

Public title

A study about feeling of fatigue reduction effect of food containing algae

Acronym

A study about feeling of fatigue reduction effect of food containing algae

Scientific Title

A study about feeling of fatigue reduction effect of food containing algae

Scientific Title:Acronym

A study about feeling of fatigue reduction effect of food containing algae

Region

Japan


Condition

Condition

Healthy adults

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The aim of this study is to confirm feeling of fatigue reduction effect for four weeks continuous consumption of test food by comparison with control food.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

VAS questionnaire about feeling of fatigue (whole body feeling of fatigue, physical feeling of fatigue and psychological feeling of fatigue )

Key secondary outcomes

*Profile of Mood States 2nd Edition
*The incidence of side effects and/or adverse events


Base

Study type

Interventional


Study design

Basic design

Parallel

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

Prevention

Type of intervention

Food

Interventions/Control_1

Intake test food once a day at dinner time for 4 weeks.

Interventions/Control_2

Intake control food once a day at dinner time for 4 weeks.

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

20 years-old <=

Age-upper limit

65 years-old >

Gender

Male and Female

Key inclusion criteria

1) Healthy males and females aged 20 to 64 years old when consent acquisition.
2) Subjects who feel fatigue on daily basis.
3) Subjects who have received enough explanation about this study and were able to understand that, then giving written informed consent.

Key exclusion criteria

1) Subjects who have previous and/or current medical history of serious disease (e.g., heart function, blood vessel, liver function, kidney function, pulmonary function, endocrine function, function of digestive organ and/or metabolism).
2) Subjects who have been diagnosed chronic fatigue syndrome, or subjects who are decided having severe fatigue such as idiopathic chronic fatigue by investigator and/or sub-investigator.
3) Subjects who are visiting hospital due to chronic disease.
4) Subjects who have psychiatric disease such as depression and/or schizophrenia.
5) Subjects who have impairment of sleep which need medical treatment.
6) Subjects who are likely to cause allergies against test food especially algae and/or seaweeds.
7) Subjects who constantly use oral medicines and/or quasi-drug having the effect of recovering from fatigue or the effect of supplementation when physical fatigue.
8) Subjects who constantly use food with functional claim about feeling of fatigue.
9) Subjects who excessive alcohol intake.
10) Subjects their BMI is less than 17 kg/m2 or equal and more than 30 kg/m2.
11) Subjects who are participating the other clinical tests. Subjects who participated within three month prior to the current study and/or who plan to participate the other clinical tests.
12) Subjects who donated over 200mL blood and/or blood components within the last one month to the current study.
13) Males who donated over 400mL blood and/or blood components within the last three month to the current study.
14) Females who donated over 400mL blood and/or blood components within the last four month to the current study.
15) Females who are pregnant or lactating, and females who could become pregnant or lactating during test period.
16) Others who have been determined ineligible by principal investigator or sub-investigator.

Target sample size

200


Research contact person

Name of lead principal investigator

1st name Suguru
Middle name
Last name Fujiwara

Organization

CPCC Company Limited

Division name

Division of Clinical Research

Zip code

101-0047

Address

4F Chusin Building, 3-3-5 Uchikanda Chiyoda-ku, Tokyo 101-0047, JAPAN

TEL

03-5297-3112

Email

cpcc-contact@cpcc.co.jp


Public contact

Name of contact person

1st name Makoto
Middle name
Last name Ichinohe

Organization

CPCC Company Limited

Division name

Planning & Sales Department

Zip code

101-0047

Address

4F Chusin Building, 3-3-5 Uchikanda Chiyoda-ku, Tokyo 101-0047, JAPAN

TEL

03-5297-3112

Homepage URL


Email

cpcc-contact@cpcc.co.jp


Sponsor or person

Institute

CPCC Company Limited

Institute

Department

Personal name



Funding Source

Organization

KOBELCO ECO-SOLUTIONS Co.,Ltd.

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

Institutional Review Board of Chiyoda Paramedical Care Clinic

Address

2F Chushin Building, 3-3-5 Uchikanda Chiyoda-ku, Tokyo 101-0047, Japan

Tel

03-5297-5548

Email

IRB@cpcc.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



Other administrative information

Date of disclosure of the study information

2020 Year 03 Month 29 Day


Related information

URL releasing protocol

http://www.pieronline.jp/content/article/0386-3603/47110/1851

Publication of results

Published


Result

URL related to results and publications

http://www.pieronline.jp/content/article/0386-3603/47110/1851

Number of participants that the trial has enrolled

200

Results

A significant reduction in feeling of physical fatigue was confirmed in the test food intake group.

Results date posted

2021 Year 08 Month 24 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

Healthy males and females aged 20 to 64 years old

Participant flow

Completed (n=200)
Analysed (n=197)

Adverse events

No adverse events were observed that be related to test food.

Outcome measures

VAS questionnaire about feeling of fatigue

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Main results already published

Date of protocol fixation

2019 Year 02 Month 18 Day

Date of IRB

2019 Year 02 Month 15 Day

Anticipated trial start date

2019 Year 03 Month 30 Day

Last follow-up date

2019 Year 08 Month 31 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 03 Month 26 Day

Last modified on

2021 Year 08 Month 24 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041351


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name