UMIN-CTR Clinical Trial

Basic information
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
Condition	No
Classification by specialty	Not applicable Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
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

Assessment
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

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -participants are blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
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

Eligibility
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

Research contact person
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

Public contact
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

Sponsor
Institute	NISSIN FOOD PRODUCTS CO., LTD.
Institute
Department

Funding Source
Organization	NISSIN FOOD PRODUCTS CO., LTD.
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	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
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	2023 Year 05 Month 20 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
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	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
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.

Management information
Registered date	2022 Year 05 Month 19 Day
Last modified on	2022 Year 09 Month 13 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054269