UMIN-CTR Clinical Trial

Public title

A study to confirm the effects of test food consumption on mental health and nutritional status during the growth period.

Acronym

A study to confirm the effects of test food consumption on mental health and nutritional status during the growth period.

Scientific Title

A study to confirm the effects of test food consumption on mental health and nutritional status during the growth period.

Scientific Title:Acronym

A study to confirm the effects of test food consumption on mental health and nutritional status during the growth period.

Region

Japan

Condition

Healthy subjects

Classification by specialty

Child

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To examine the continuous ingestion of test food on psychological stability and nutritional status in growing children.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Developmental phase

Not applicable

Primary outcomes

Psychological examination, blood biochemical tests, blood mineral level, anemia level, physical examination

Key secondary outcomes

observation log

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Single blind -investigator(s) and assessor(s) are blinded

Control

No treatment

Stratification

Dynamic allocation

YES

Institution consideration

Blocking

YES

Concealment

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

Test foods, Continuous intake for 4 weeks

Interventions/Control_2

non-intervention, Continuous 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

12

years-old

<=

Age-upper limit

13

years-old

>

Gender

Male and Female

Key inclusion criteria

(1)Healthy male and female of 12 years of age at the time point of acquiring the informed consent.
(2)Parents of healthy male and female who are 12 years of age at the time point of acquiring the informed consent.
(3) Subjects who are not making regular visits to hospitals, taking medication, nor receiving follow-up care from any physician.
(4) Subjects who are experiencing some kind of stress in their daily lives.
(5) Subjects who agree to have their blood taken (approximately 10 mL) from the arm twice (before and at the end of the test) without any problems.
(6) Subjects who are able to drink the test beverage once daily.
(7) Subjects whose BMI is between male16.5 kg/m^2 and 27.0 kg/m^2, female 17.0 kg/m^2 and 27.0 kg/m^2
(8) Subjects whose body weight is between 35 kg and 55 kg
(9) Parents must cooperate in filling out the diary and questionnaires.
(10) Subjects who have received explanation and understood about this study, and who can consent to the content on the informed consent documents.
(11) Subject who can answer the interview on the day of the study regarding menstruation (female participants only).
(12) Children who are judged by the investigator that they have no problem participating in the study.

Key exclusion criteria

(1) Subjects who have or suspected infectious disease such as COVID-19, or who had close contact with such disease on study entry.
(2) Subjects who have a history of medication, hospitalization, or surgery within a year.
(3) Subjects who have a history of any kind of suggestion or guidance from a physician regarding blood glucose levels or insulin secretion.
(4) Subjects who are currently on any medical treatments, or who are planning some kind of treatments during the study period.
(5) Subjects who constantly take medicines, health foods and/or supplements that may affect the test results. (including vitamins, etc.)
(6) Subjects whose BMI is less than male 16.5 kg/m^2, female 17.0 kg/m^2 and male and female over than 27.0 kg/m^2
(7) Weight less than 35 kg or over 55 kg
(8) Subjects who feel nausea, dizziness, loss of consciousness, extreme nervousness, or fear when having blood test (including reactions such as crying or violent outbursts).
(9) Subjects who cannot intake the foods containing cacao (because of preference, headache, etc.)
(10) Subjects who have a habit of strenuous physical activity such as being a member of an athletic club.
(11) Subjects who have allergy in medicine, foods. (Especially milk, and almonds).
(12) Subjects who are unable to come to the hospital on the day of the examination.
(13) Subjects who have participated in other clinical trials within 3 months prior to the date of consent, are currently participating in a clinical trial of another drug or health food, or are scheduled to participate in another clinical trial after consent to participate in this trial.
(14) Subjects judged by the principal investigator to be unsuitable for participation in the study.

Target sample size

32

Name of lead principal investigator

1st name	Toshihiro
Middle name
Last name	Kawama

Organization

Morinaga & Co., Ltd

Division name

Health Science and Research Center, R&D institute

Zip code

230-8504

Address

2-1-1, Shimosueyoshi, Tsurumi-ku, Yokohama

TEL

045-571-6140

Email

t-kawama-jb@morinaga.co.jp

Name of contact person

1st name	Hiroyuki
Middle name
Last name	Inagaki

Organization

Morinaga & Co., Ltd

Division name

Health Science and Research Center, R&D institute

Zip code

230-8504

Address

2-1-1, Shimosueyoshi, Tsurumi-ku, Yokohama

TEL

045-571-6140

Homepage URL

Email

h-inagaki-jj@morinaga.co.jp

Institute

Morinaga & Co., Ltd

Institute

Department

Personal name

Organization

Morinaga & Co., Ltd

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Japan Conference of Clinical Research

Address

1-13-23 Minamiikebukuro Toshima-ku, Tokyo 171-0022, Japan

Tel

03-6868-7022

Email

jccr-info@jccr.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

赤坂ファミリークリニック（東京都）/ Akasaka Family Clinic (Tokyo)

Date of disclosure of the study information

2023

Year

06

Month

30

Day

URL releasing protocol

https://www.sciencexcel.com/Archives+of+Clinical+Trials/archieve

Publication of results

Published

URL related to results and publications

https://www.sciencexcel.com/Archives+of+Clinical+Trials/archieve

Number of participants that the trial has enrolled

38

Results

We analyzed the GHQ and blood test results of 37 children. There was a significant improvement in stress level from GHQ, and in serum Dihomo-gamma-linolenic acid (DGLA) of children in the
cocoa group compared to those in the control group.

Results date posted

2024

Year

10

Month

22

Day

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

healthy 12 year-old child

Participant flow

The consuming group consumed the test drink at home, which could be dissolved in a glass of hot water daily for four weeks. The non-consuming group lived a normal life. Both groups refrained from eating sweets and foods containing cocoa, such as chocolate and cocoa, during the four weeks of the study.

Adverse events

None

Outcome measures

GHQ-12
Blood test

Plan to share IPD

IPD sharing Plan description

Recruitment status

Main results already published

Date of protocol fixation

2022

Year

08

Month

19

Day

Date of IRB

2022

Year

08

Month

19

Day

Anticipated trial start date

2022

Year

10

Month

16

Day

Last follow-up date

2022

Year

11

Month

27

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2022

Year

08

Month

30

Day

Last modified on

2024

Year

10

Month

22

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055594