UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000043895
Receipt number R000050060
Scientific Title Effect of "healthy diet" intake on health awareness and physical condition
Date of disclosure of the study information 2021/04/12
Last modified on 2022/04/14 13:59:06

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Basic information

Public title

Effect of "healthy diet" intake on health awareness and physical condition

Acronym

Effect of "healthy diet" intake on health awareness and physical condition

Scientific Title

Effect of "healthy diet" intake on health awareness and physical condition

Scientific Title:Acronym

Effect of "healthy diet" intake on health awareness and physical condition

Region

Japan


Condition

Condition

Healthy subjects

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The objective this study examines changes in health consciousness and physical condition by eating a "healthy diet" that is a balanced combination of multiple nutritional components that are considered to be good for healthy at breakfast and lunch, compared with before intake.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Vital signs,Body measurements (weight, BMI),Bone density measurement,Visceral fat measurement,WLQ-J,University of Tokyo 1 item version of presenteeism,Dietary habits awareness survey,Blood biochemistry,Intestinal flora test,Defecation survey.

Key secondary outcomes

Adverse events


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

4-weeks intake of the test food

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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1)Employees working in cooperative company.
2)Subject who can be inspected on the specified inspection date.
3)Subject with a BMI of 23 kg/m2 or more.
4)Subject who has understood the purpose of the study, and agreed to participate it by signing the written informed consent.

Key exclusion criteria

1)Subject who cannot continue to take the test food due to business trips during the intake period (sbject who is known in advance that the eating rate will be less than 80%).
2)Subject who is taking medication or under medical treatment.
3)Subject who is under exercise therapy or dietetic therapy.
4)Subject who has an allergy for test food.
5)Subject who has or had a history of either medicine or alcohol dependence syndrome.
6)Subject who has or had a history of mental illness (depression) or sleep disturbance.
7)Subject who has irregular work rhythms such as working at night and shift work.
8)Subject who has extremely irregular lifestyle such as eating and sleeping.
9)Subject who has an unbalanced diet.
10)Subject who has or had a history of severe diseases such as brain disease, malignant tumor, immune disease, diabetes, liver disease (hepatitis), kidney disease, heart disease, thyroid disease, adrenal disease, other metabolic diseases (including subject who uses implantable medical electrical equipment such as pacemakers, subject who uses implantable metal medical equipment, and subject who is undergoing artificial dialysis).
11)Subject who has participated in other clinical studies within the past 3 months from the day of the consent acquisition or who is planning to participate in other clinical studies during the current study.
12)Subject who has blood drawn or blood component more than 200mL within the past 1 months or more than 400mL within the past 3 months from the day of the consent acquisition.
13))Subject who is planning to get pregnant after the day of informed consent or is currently pregnant and lactating.
14)Subject who can't keep the daily records.
15)Subject who is judged as an inappropriate candidate according to the screening data.
16)Subject who is considered as an inappropriate candidate by the doctor in charge.

Target sample size

100


Research contact person

Name of lead principal investigator

1st name Daisuke
Middle name
Last name Ochitani

Organization

HUMA R&D CORP

Division name

Clinical Development Division

Zip code

108-0014

Address

Round Cross Tamachi 10F 5-31-19 Shiba Minato-ku Tokyo 108-0014 Japan

TEL

03-3431-1260

Email

ochitani@huma-rd.co.jp


Public contact

Name of contact person

1st name Daisuke
Middle name
Last name Ochitani

Organization

HUMA R&D CORP

Division name

Clinical Development Division

Zip code

108-0014

Address

Round Cross Tamachi 10F 5-31-19 Shiba Minato-ku Tokyo 108-0014 Japan

TEL

03-3431-1260

Homepage URL


Email

ochitani@huma-rd.co.jp


Sponsor or person

Institute

HUMA R&D CORP

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

NISHI-UMEDA Clinic for Asian Medical Collaboration Clinical Research Institutional Review Board

Address

West Umeda Building 3F 3-3-45 Umeda Kita-ku Osaka Japan,530-0001

Tel

06-4797-5660

Email

jimukyoku@amc-clinc.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 04 Month 12 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

67

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 11 Day

Date of IRB

2021 Year 03 Month 25 Day

Anticipated trial start date

2021 Year 04 Month 13 Day

Last follow-up date

2021 Year 06 Month 25 Day

Date of closure to data entry

2021 Year 09 Month 03 Day

Date trial data considered complete

2021 Year 09 Month 22 Day

Date analysis concluded

2021 Year 12 Month 08 Day


Other

Other related information



Management information

Registered date

2021 Year 04 Month 12 Day

Last modified on

2022 Year 04 Month 14 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050060


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name