UMIN-ICDS Clinical Trial

Public title

Effects of Consumption of Complete Nutritional Diets with Different PFC Balance on Biological Rhythms and Visceral Fat.

Acronym

Effects of Consumption of Complete Nutritional Diets with Different PFC Balance on Biological Rhythms and Visceral Fat.

Scientific Title

Effects of Consumption of Complete Nutritional Diets with Different PFC Balance on Biological Rhythms and Visceral Fat.

Scientific Title:Acronym

Effects of Consumption of Complete Nutritional Diets with Different PFC Balance on Biological Rhythms and Visceral Fat.

Region

Japan

Condition

No

Classification by specialty

Not applicable

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

This study aims to examine the effects of the ingestion of the test food on biological rhythms and visceral fat.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

[1]Indexes for biological rhythm and visceral fat (biological rhythm, stress, sleep, FatScan visceral fat area using CT scan images).

Key secondary outcomes

*Secondary indexes
[1] Indexes for body composition.
[2] Physical and clinical examinations.
[3] Specific blood test
[4] Specific fecal test
[5] Specific urinary test
[6] Measurement of subcutaneous fat area by FatScan using CT scan images.
[7] Heart rate variability test under orthostatic load.
[8] Blood glucose measurement with Free Style Libre.
[9] Food frequency questionnaire:FFQ
[10] State-Trait Anxiety Inventory-JYZ
[11] The Japanese version of the Pittsburgh Sleep Quality Index.

*Safety
[1] Doctor's questions
[2] Side effects and adverse events
[3] Subject's diary

*Other indexes
[1]Evaluation of visceral fat mass area by impedance method

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Single blind -participants are blinded

Control

No treatment

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

3

Purpose of intervention

Treatment

Type of intervention

Food

Interventions/Control_1

Oral intake of the control meal (4 times in a day [eating for breakfast, lunch, dinner, and snacks; 4 weeks.).

Interventions/Control_2

Oral intake of test meal A (4 times in a day [eating for breakfast, lunch, dinner, and snacks; 4 weeks.).

Interventions/Control_3

Oral intake of test meal B (4 times in a day [eating for breakfast, lunch, dinner, and snacks; 4 weeks.).

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

30

years-old

<=

Age-upper limit

65

years-old

>

Gender

Male and Female

Key inclusion criteria

[1]Healthy Japanese males and females aged 30-64 years.
[2] Individuals whose BMI is more than 23.0 kg 2 and less than 30.0 Kg 2.
[3] Individuals who consume alcohol regularly in terms of frequency and quantity, and have a habit of daily consuming about 20 g/day of pure alcohol equivalent.
[4]Individuals whose written informed consent has been obtained.
[5]Individuals who can visit an inspection facility and be inspected in designated days.
[6]Individuals judged appropriate for the study by the principal.

Key exclusion criteria

[1] Individuals who cannot continue to eat a test meal for 4 weeks.
[2] Individuals whose eating habit for breakfast, lunch, and dinner is irregular and has an unbalanced diet.
[3] Individuals who are in constipation.
[4] Individuals using medical products.
[5] Individuals who are patient or have a history of psychiatric disease, high blood pressure, diabetes, and hyperlipidemia.
[6] Individuals with arrhythmias including atrial fibrillation.
[7] Individuals with a history of syncope.
[8] Individuals who are patient or have a history of psychiatric disease, high blood pressure, diabetes, and hyperlipidemia.
[9] Individuals who have a history of serious hepatopathy, kidney damage, heart disease, hematological and blood disease.
[10] Individuals who contract or have a history of serious endocrine disease.
[11] Individuals with metal in their body that cannot be removed. Individuals with a cardiac pacemaker.
[12] Individuals who recorded weight gain and loss (+-2 kg) in the past 1 month.
[13] Individuals who donated blood over 200mL in the past 1 month or over 400mL in the past 3 months.
[14] Individuals who are sensitive to test product or other foods, and medical products.
[15] Individuals who are undergoing dietary therapy
[16] Individuals who are allergic to metals or who are at risk of developing allergies to metals
[17] Individuals with possible changes of lifestyle, such as conducting a long-term travel, during the test period.
[18] Individuals who have or had a habit to ingest health-promoting foods, foods for specified health uses, or health foods in the past 3 months, or will ingest those foods during the test period.
[19] Individuals who are or are possibly pregnant, or are lactating.
[20] Individuals who participated in other clinical studies in the past 3 months.
[21] Individuals who are or whose family is engaged in health foods of functional foods.
[22] Individuals judged inappropriate for the study by the principal.

Target sample size

300

Name of lead principal investigator

1st name	Futoshi
Middle name
Last name	Nakamura

Organization

NISSIN FOODS HOLDINGS CO., LTD.

Division name

New Business Development Division

Zip code

192-0001

Address

2100 Tobukimachi, Hachioji-shi, Tokyo

TEL

+81-42-696-7606

Email

futoshi.nakamura@nissin.com

Name of contact person

1st name	Ryoma
Middle name
Last name	Shimizu

Organization

TES Holdings Co., Ltd.

Division name

Administrative Department of Clinical Trials

Zip code

110-0015

Address

6F Kairaku Building 2-7-5 Higashiueno Taito-ku Tokyo 110-0015, JAPAN

TEL

+81-3-6801-8480

Homepage URL

Email

r.shimizu@tes-h.co.jp

Institute

NISSIN FOOD PRODUCTS CO., LTD.

Institute

Department

Personal name

Organization

NISSIN FOOD PRODUCTS CO., LTD.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Ueno-Asagao Clinic Ethical Review Committee

Address

6F Kairaku Building 2-7-5 Higashiueno Taito-ku Tokyo 110-0015, JAPAN

Tel

+81-3-6240-1162

Email

i.takahashi@tes-h.co.jp

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

2023

Year

05

Month

20

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Terminated

Date of protocol fixation

2022

Year

03

Month

28

Day

Date of IRB

2022

Year

03

Month

30

Day

Anticipated trial start date

2022

Year

06

Month

18

Day

Last follow-up date

2022

Year

08

Month

16

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

A fire broke out in the warehouse, where the test food was stored, made the test food unusable. Therefore it was difficult to continue the test and the test was cancelled.

Registered date

2022

Year

05

Month

19

Day

Last modified on

2022

Year

09

Month

13

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000054269