UMIN-CTR Clinical Trial

Public title

Effects of Food Ingredient Intake During Me-Time Activities on Psychological and Behavioral Outcomes

Acronym

Effects of Food Ingredient Intake During Me-Time Activities on Psychological and Behavioral Outcomes

Scientific Title

Effects of Food Ingredient Intake During Me-Time Activities on Psychological and Behavioral Outcomes

Scientific Title:Acronym

Effects of Food Ingredient Intake During Me-Time Activities on Psychological and Behavioral Outcomes

Region

Japan

Condition

Healthy adults

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

This study aims to exploratorily investigate the effects of food ingredients contained in beverages consumed during Me-time, defined as the period between dinner and bedtime spent in a private setting after work or school on a day preceding another work or school day, on psychological and behavioral outcomes immediately after consumption and on the following day. Previous survey findings suggested that consuming more stimulating beverages, compared with relaxing beverages, may enhance the value of Me-time, including improvements in sleep quality and motivation the next morning. Through a three-week intervention, this study will evaluate the effectiveness of individual food ingredients rather than beverages as a whole and generate evidence to improve understanding of the effects of beverage ingredients in daily life and to support future product development.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Relaxation level immediately after Me-Time activities
Motivation upon waking
Characteristics of online content viewed during Me-Time activities

Key secondary outcomes

Study type

Interventional

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Cluster

Blinding

Single blind -participants are blinded

Control

Placebo

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

3

Purpose of intervention

Educational,Counseling,Training

Type of intervention

Food

Interventions/Control_1

During Me-Time Activities, the following three conditions will be assigned to each participant in a randomized order over the intervention period:
- A week during which participants consume one bottle of a control beverage (Drink P) per day.
- A week during which participants consume one bottle of a beverage containing added flavoring ingredients (Drink Q) per day.
- A week during which participants do not consume either study beverage.

Interventions/Control_2

During Me-Time Activities, the following three conditions will be assigned to each participant in a randomized order over the intervention period:
- A week during which participants consume one bottle of a control beverage (Drink R) per day.
- A week during which participants consume one bottle of a beverage containing added flavoring ingredients (Drink S) per day.
- A week during which participants do not consume either study beverage.

Interventions/Control_3

During Me-Time Activities, the following three conditions will be assigned to each participant in a randomized order over the intervention period:
- A week during which participants consume one bottle of a control beverage (Drink T) per day.
- A week during which participants consume one bottle of a beverage containing added flavoring ingredients (Drink U) per day.
- A week during which participants do not consume either study beverage.

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

20

years-old

<=

Age-upper limit

60

years-old

>

Gender

Male and Female

Key inclusion criteria

Eligible participants are healthy adult men and women who have understood the contents of this study and provided written informed consent. Participants must habitually use social media or browse the internet during their Me-Time and must be able to receive 10 bottles of the study beverages and store them under refrigerated conditions during the study period (up to 3 weeks).

In this study, participants will be recruited from the NTT Com Research Monitor, a panel managed by NTT Com Online Marketing Solutions. The NTT Com Research Monitor consists of approximately 8 million registered individuals ranging in age from their teens to their seventies. This service regularly conducts web-based surveys and interviews to collect opinions on systems, policies, and other topics. All registered members have agreed to the terms and conditions regarding information provision, including the handling of personal data, through NTT Com Research.
For this study, individuals registered with this service will serve as the target population.

Key exclusion criteria

Individuals who have difficulty consuming beverages containing herbal flavorings or carbonated beverages used in this study, who do not habitually engage in social media use or internet browsing during their Me-Time, or who are considered unable to comply with the study procedures and assessments will be excluded.

Target sample size

90

Name of lead principal investigator

1st name	Mina
Middle name
Last name	Takase

Organization

NTT DATA INSTITUTE OF MANAGEMENT CONSULTING,Inc.

Division name

Neuro-Cognitive Innovation Unit

Zip code

1020093

Address

JA Kyosai Bldg, 10th Fl., 7-9, Hirakawacho 2-chome, Chuyoda-ku Tokyo 102-0093, Japan

TEL

08013666354

Email

takasemi@nttdata-strategy.com

Name of contact person

1st name	Mina
Middle name
Last name	Takase

Organization

NTT DATA INSTITUTE OF MANAGEMENT CONSULTING,Inc.

Division name

Neuro-Cognitive Innovation Unit

Zip code

1020093

Address

JA Kyosai Bldg, 10th Fl., 7-9, Hirakawacho 2-chome, Chuyoda-ku Tokyo 102-0093, Japan

TEL

08013666354

Homepage URL

Email

takasemi@nttdata-strategy.com

Institute

NTT DATA INSTITUTE OF MANAGEMENT CONSULTING,Inc.

Institute

Department

Personal name

Organization

Asahi Quality and Innovations .Inc

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

NTT DATA INSTITUTE OF MANAGEMENT CONSULTING,Inc.

Address

JA Kyosai Bldg, 10th Fl., 7-9, Hirakawacho 2-chome, Chuyoda-ku Tokyo 102-0093, Japan

Tel

08013666354

Email

takasemi@nttdata-strategy.com

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2026

Year

11

Month

13

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

90

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

Recruitment status

No longer recruiting

Date of protocol fixation

2026

Year

10

Month

29

Day

Date of IRB

2026

Year

10

Month

29

Day

Anticipated trial start date

2026

Year

10

Month

29

Day

Last follow-up date

2031

Year

12

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2026

Year

11

Month

11

Day

Last modified on

2026

Year

11

Month

11

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072693