UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000043726
Receipt number R000049928
Scientific Title Effects of test food on subjective symptoms in healthy subjects who exercise regularly: a randomized, double-blind, placebo-controlled trial.
Date of disclosure of the study information 2021/03/24
Last modified on 2021/10/26 17:46:15

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Basic information

Public title

Effects of test food on subjective symptoms in healthy subjects who exercise regularly: a randomized, double-blind, placebo-controlled trial.

Acronym

Effects of test food on subjective symptoms in healthy subjects who exercise regularly.

Scientific Title

Effects of test food on subjective symptoms in healthy subjects who exercise regularly: a randomized, double-blind, placebo-controlled trial.

Scientific Title:Acronym

Effects of test food on subjective symptoms in healthy subjects who exercise regularly.

Region

Japan


Condition

Condition

None (Healthy subjects)

Classification by specialty

Not applicable Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate the effect of test food on subjective symptoms.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Subjective symptoms

Key secondary outcomes

Immune indices


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

YES

Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

Ingestion of test food for 4 weeks.

Interventions/Control_2

Ingestion of placebo 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

18 years-old <=

Age-upper limit

65 years-old >

Gender

Male

Key inclusion criteria

1) Male subjects between 18 to 65 years old.
2) Subjects who exercise regularly.

Key exclusion criteria

1) Subjects who can not stop taking supplements or functional foods which may affect immune functions.
2) Subjects having a milk allergy.
3) Subjects who have a history of serious allergic disease.
4) Subjects who need the application of medicine containing steroids.
5) Subjects who regularly consume foods containing an active ingredients.
6) Extremely heavy drinkers (more than 60g/day of alcohol).
7) Subjects who can not sleep at night due to irregular work or other reasons.
8) Subjects who are being treated for chronic disease.
9) Subjects who are positive in the pathogen test.
10) Subjects who have serious disease in the liver, kidney heart, lung, gastrointestinal tract, blood, endocrine system, or metabolic system etc. Or those who have serious medical history of these.
11) Subjects whose research managers judged inappropriate as subjects.

Target sample size

84


Research contact person

Name of lead principal investigator

1st name Shigeru
Middle name
Last name Saito

Organization

Matsumoto University

Division name

Graduate School of Health Science

Zip code

390-1295

Address

2095-1, Niimura, Matsumoto-city, Nagano

TEL

0263-48-7340

Email

shigeru.saito@t.matsu.ac.jp


Public contact

Name of contact person

1st name Shigeru
Middle name
Last name Saito

Organization

Matsumoto University

Division name

Graduate School of Health Science

Zip code

390-1295

Address

2095-1, Niimura, Matsumoto-city, Nagano

TEL

0263-48-7340

Homepage URL


Email

shigeru.saito@t.matsu.ac.jp


Sponsor or person

Institute

Matsumoto University

Institute

Department

Personal name



Funding Source

Organization

Morinaga Milk Industry 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

Matsumoto University

Address

2095-1, Niimura, Matsumoto-city, Nagano

Tel

0263-48-7340

Email

shigeru.saito@t.matsu.ac.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

2021 Year 03 Month 24 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

2021 Year 03 Month 08 Day

Date of IRB

2021 Year 03 Month 08 Day

Anticipated trial start date

2021 Year 03 Month 25 Day

Last follow-up date

2021 Year 06 Month 30 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2021 Year 03 Month 24 Day

Last modified on

2021 Year 10 Month 26 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049928


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name