UMIN-CTR Clinical Trial

Public title

A study to evaluate the effect of multi-supplement intake on attenuating fatigue sensation

Acronym

The effect of multi-supplement intake on attenuating fatigue sensation

Scientific Title

A study to evaluate the effect of multi-supplement intake on attenuating fatigue sensation

Scientific Title:Acronym

The effect of multi-supplement intake on attenuating fatigue sensation

Region

Japan

Condition

Healthy volunteers

Classification by specialty

Not applicable

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To investigate the effect of the multi-supplement on attenuating fatigue in daily life : a randomized, double-blind, placebo-controlled, 2-way crossover study

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Visual analogue scale (VAS),
Chalder Fatigue Scale

Key secondary outcomes

Advanced trail making test (ATMT), 10-second high power test, spectrum analysis a-a interval of accelerated plethysmography, POMS 2 Adult Short, OSA sleep inventory MA version, oxidative stress markers, safety evaluation

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

Prevention

Type of intervention

Food

Interventions/Control_1

Intake of Test food (4 weeks) -> Washout (4 weeks) -> Intake of Placebo (4 weeks)

Interventions/Control_2

Intake of Placebo (4 weeks) -> Washout (4 weeks) -> Intake of Test food (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

Age-lower limit

30

years-old

<=

Age-upper limit

60

years-old

>=

Gender

Male and Female

Key inclusion criteria

1) Healthy males and females aged from 30 to 60 years (bounds included)
2) Subject whose total score of Chalder Fatigue Scale is 21 or more
3) Subject having a briefing of the content of the present study, fully understanding and agreeing to its objective and being able to personally sign a written informed consent

Key exclusion criteria

1) Subject receiving a medical treatment for serious renal, hepatic, cardio-vascular, respiratory, endocrine or metabolic disorders or having a medical history of these disorders
2) Subject having the chronic fatigue syndrome (CFS), or subject deemed to have severe fatigue like idiopathic chronic fatigue by the investigator
3) Subject having food allergy (gelatin)
4) Subject having a medical history of chest pain or syncope
5) Subject having an abnormality in the electrocardiogram
6) Subject having a subjective symptom of low back pain, arthralgia or lumbar hernia, disease of lower limbs, palpitations
7) Subject who regularly takes medicine or quasi-drugs having the efficacy on recovery of fatigue or nutrition disorder at physical fatigue
8) Subject who regularly takes processed food containing ingredients known to attenuate fatigue sensation
9) Subject who regularly takes food containing large amounts of carotenoid
10) Subject having blood sample of 200 ml or more taken within 1 month, or 400 ml or more within 3 months prior to the start of the present study (e.g. donated blood)
11) Subject who took part in another clinical study within 3 months prior to the start of the present study or who is currently taking part in another clinical study
12) Female subject who is pregnant or lactating, or intending to become pregnant during the study
13) Subject deemed unsuitable by the investigator

Target sample size

20

Name of lead principal investigator

1st name
Middle name
Last name	Osami Kajimoto

Organization

Osaka City University Graduate School of Medicine

Division name

Department of Medical Science on Fatigue

Zip code

Address

1-4-3 Asahi-machi, Abeno-ku, Osaka

TEL

06-6645-6171

Email

kajimoto@med.osaka-cu.ac.jp

Name of contact person

1st name
Middle name
Last name	Tomohiro Sugino

Organization

Soiken Inc.

Division name

R&D Division

Zip code

Address

Senri Life Science Center 13F, 1-4-2,Shinsenri-higashimachi,Toyonaka,Osaka

TEL

06-6871-8888

Homepage URL

Email

sugino@soiken.com

Institute

Soiken Inc.

Institute

Department

Personal name

Organization

FUJIFILM Corporation

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

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

2018

Year

05

Month

14

Day

URL releasing protocol

Publication of results

Published

URL related to results and publications

https://www.mdpi.com/2072-6643/10/3/281/htm

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

2016

Year

06

Month

18

Day

Date of IRB

Anticipated trial start date

2016

Year

08

Month

27

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2016

Year

08

Month

25

Day

Last modified on

2019

Year

03

Month

01

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027359