UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000044321
Receipt number R000050624
Scientific Title Influence on physical condition by "healthy meal" intake on obese males
Date of disclosure of the study information 2021/05/25
Last modified on 2021/11/24 09:04:26

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Basic information

Public title

Influence on physical condition by "healthy meal" intake on obese males

Acronym

Influence on physical condition by "healthy meal" intake on obese males

Scientific Title

Influence on physical condition by "healthy meal" intake on obese males

Scientific Title:Acronym

Influence on physical condition by "healthy meal" intake on obese males

Region

Japan


Condition

Condition

Not applicable

Classification by specialty

Not applicable Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the change on physical condition by "healthy meal" intake

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

visceral fat area

Key secondary outcomes

BMI, blood triglyceride level


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Self control

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

Intake "healthy meal A" for 20 days

Interventions/Control_2


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

30 years-old <=

Age-upper limit

64 years-old >=

Gender

Male

Key inclusion criteria

1) Males aged between 30 and 64
2) Subjects who equal to or more than 23 kg/m2 of BMI
3) Among the subjects who met the inclusion criteria 1) and 2), select from the subjects with high visceral fat area

Key exclusion criteria

1) Subjects who are unable to continuously intake "healthy meal" during intake period
2) Subjects who are judged as unsuitable for the study based on the results of lifestyle questionnaire and the results of preliminary examination
3) Subjects who are judged as unsuitable for the study based on the medical history
4) Subjects with food allergies
5) Subjects who have difficulty in treatment by participating in the study
6) Subjects who are receiving treatment or use equipment that affects the examination
7) Subjects who are judged as unsuitable for the study based on the results of clinical and physical examination on preliminary examination
8) Subjects who have participated in other clinical study prior to the current study
9) Subjects who routinely take health foods that may affect the results
10) Subjects who has a history of disease that may affect the results
11) Subjects who has a habit of skipping breakfast
12) Subjects who regularly consume large amount of alcohol
13) Subjects who smoke excessively (more than 21 cigarettes a day)
14) Subjects with extremely irregular diet
15) Subjects with irregular life rhythms
16) Subjects who undergoes a medical examination from 2 weeks before the preliminary examination and the end of the study
17) Subjects who plan to donate blood during the study period
18) Subjects who judged as unsuitable for the study by the investigator for other reasons

Target sample size

30


Research contact person

Name of lead principal investigator

1st name Kazuyuki
Middle name
Last name Mizuyama

Organization

Medical Foundation Doujinkinenkai Meiwa Hospital

Division name

Internal medicine

Zip code

101-0041

Address

1-18, Kanda Sudacho, Chiyoda-ku, Tokyo

TEL

03-3251-0263

Email

mizuyama@crux.ocn.ne.jp


Public contact

Name of contact person

1st name Hiroyasu
Middle name
Last name Shimada

Organization

EP Mediate Co., Ltd.

Division name

Development Business Headquarters, TTC Center, Trial Planning Department

Zip code

162-0822

Address

Turuya Bldg.,2-23, Shimomiyabicho, Shinjuku-ku, Tokyo

TEL

03-5657-4983

Homepage URL


Email

shimada767@eps.co.jp


Sponsor or person

Institute

EP Mediate Co., Ltd.

Institute

Department

Personal name



Funding Source

Organization

non-disclosure

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

Medical Station Clinic Research Ethics Committee

Address

3-12-8, Takaban, Meguro-ku, Tokyo

Tel

03-6452-2712

Email

saito876@eps.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

2021 Year 05 Month 25 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

30

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

No longer recruiting

Date of protocol fixation

2021 Year 05 Month 13 Day

Date of IRB

2021 Year 05 Month 13 Day

Anticipated trial start date

2021 Year 05 Month 18 Day

Last follow-up date

2021 Year 08 Month 05 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 05 Month 25 Day

Last modified on

2021 Year 11 Month 24 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050624


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name