UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000033892
Receipt number R000038656
Scientific Title A clinical study to evaluate the effects of imidazole dipeptides on improving fatigue sensation
Date of disclosure of the study information 2019/12/02
Last modified on 2023/03/24 10:00:15

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Basic information

Public title

A clinical study to evaluate the effects of imidazole dipeptides on improving fatigue sensation

Acronym

A clinical study to evaluate the effects of imidazole dipeptides on improving fatigue sensation

Scientific Title

A clinical study to evaluate the effects of imidazole dipeptides on improving fatigue sensation

Scientific Title:Acronym

A clinical study to evaluate the effects of imidazole dipeptides on improving fatigue sensation

Region

Japan


Condition

Condition

Healthy Volunteers

Classification by specialty

Not applicable Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate the effects of imidazole dipeptides on improving fatigue sensation: a randomized, double-blind, placebo-controlled, crossover study

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

VAS (fatigue sensation)

Key secondary outcomes

Chalder fatigue scale, T score of "fatigue-inertia" in subscale of POMS2 short version, Performance test (10-second high power test) after 4-week intake


Base

Study type

Interventional


Study design

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



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Food

Interventions/Control_1

Intake of test food for 4 weeks -> Washout for 4 weeks -> Intake of Placebo for 4 weeks

Interventions/Control_2

Intake of Placebo for 4 weeks -> Washout for 4 weeks -> Intake of test food 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

40 years-old <=

Age-upper limit

65 years-old >

Gender

Male and Female

Key inclusion criteria

1) Subjects whose age of 40 years or more and less than 65 years
2) Subjects who were evaluated 40 or more in T score of "fatigue-inertia" in subscale of POMS2 short version
3) Subjects receiving a sufficient briefing of the objective and content of the present study, fully understanding and agreeing to voluntary participate in the study and being able to personally sign a written informed consent

Key exclusion criteria

1) Subjects receiving a medical treatment for serious renal, hepatic, cardio-vascular, respiratory, endocrine or metabolic disorders or having a medical history of these disorders
2) Subjects having the chronic fatigue syndrome (CFS), or subjects deemed to have severe fatigue like idiopathic chronic fatigue by the investigator
3) Subjects having a medical history of chest pain or syncope
4) Subjects deemed unsuitable in the electrocardiogram by the investigator
5) Subjects having a subjective symptom of low back pain, arthralgia or lumber hernia, disease of lower limbs, palpitations
6) Subjects who have the possibility of developing allergic symptoms by the test food
7) Subjects who take regularly pharmaceuticals or quasi-drugs which having the efficacy for recovery from fatigue or nutrient replenishment in case of physical fatigue
8) Subjects who take regularly supplements of protein or amino acid drink
9) Subjects who take regularly Foods with Function Claims labeled the effect of attenuating fatigue sensation
10) Subjects 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) Subjects who took part in another clinical study within 1 month prior to the start of the present study or who is currently taking part in another clinical study
12) Female subjects who are pregnant or lactating, or intending to become pregnant during the study
13) Subjects deemed unsuitable by the investigator

Target sample size

12


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Mikako Sato

Organization

NH Foods Ltd.

Division name

R&D Center

Zip code


Address

3-3 Midorigahara, Tsukuba, Ibaraki

TEL

029-847-7815

Email

m.satou@nipponham.co.jp


Public contact

Name of contact person

1st name
Middle name
Last name Tomohiro Sugino

Organization

Soiken Inc.

Division name

Representative Director

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


Sponsor or person

Institute

Soiken Inc.

Institute

Department

Personal name



Funding Source

Organization

NH Foods 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


Address


Tel


Email



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

2019 Year 12 Month 02 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

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



Progress

Recruitment status

Completed

Date of protocol fixation

2018 Year 08 Month 18 Day

Date of IRB

2018 Year 08 Month 18 Day

Anticipated trial start date

2018 Year 08 Month 25 Day

Last follow-up date

2018 Year 12 Month 02 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2018 Year 08 Month 25 Day

Last modified on

2023 Year 03 Month 24 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038656


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name