UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000047873 |
|---|---|
| Receipt number | R000054507 |
| Scientific Title | The Effects of Dietary Fiber-Enriched Complete Nutritional Diet on Intestinal Immune Activation and Visceral Fat. |
| Date of disclosure of the study information | 2023/06/07 |
| Last modified on | 2023/08/09 10:09:28 |
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Basic information
Public title
The Effects of Dietary Fiber-Enriched Complete Nutritional Diet on Intestinal Immune Activation and Visceral Fat.
Acronym
The Effects of Dietary Fiber-Enriched Complete Nutritional Diet on Intestinal Immune Activation and Visceral Fat.
Scientific Title
The Effects of Dietary Fiber-Enriched Complete Nutritional Diet on Intestinal Immune Activation and Visceral Fat.
Scientific Title:Acronym
The Effects of Dietary Fiber-Enriched Complete Nutritional Diet on Intestinal Immune Activation 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 effects of dietary fiber-enriched complete nutritional diet on intestinal immune activation and visceral fat.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
[1] Indexes for visceral fat area and genetic analysis.
Key secondary outcomes
*Secondary indexes
[1] Specific fecal test
[2] Specific blood test
[3] Indexes for body composition.
[4] Physical and clinical examinations.
[5] Measurement of subcutaneous fat area by FatScan using CT scan images.
[6] Food frequency questionnaire:FFQ
*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
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Oral intake of test meal A (4 times in a day [eating for breakfast, lunch, dinner, and snacks; 4 weeks.).
Interventions/Control_2
Oral intake of normal meals (keeping habit of eating before participating with the study; 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
Eligibility
Age-lower limit
| 30 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male
Key inclusion criteria
[1] Healthy Japanese males aged 30-64 years.
[2] Individuals whose visceral fat area is over 100cm2.
[3] Individuals who do not have a habit of drinking.
[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 who are patient or have a history of psychiatric disease, high blood pressure, diabetes, and hyperlipidemia.
[7] Individuals who have a history of serious hepatopathy, kidney damage, heart disease, hematological and blood disease.
[8] Individuals who contract or have a history of serious endocrine disease.
[9] Individuals with metal in their body that cannot be removed. Individuals with a cardiac pacemaker.
[10] Individuals who recorded weight gain and loss (+-2 kg) in the past 1 month.
[11] Individuals who donated blood over 200mL in the past 1 month or over 400mL in the past 3 months.
[12] Individuals who are sensitive to test product or other foods, and medical products.
[13] Individuals who are undergoing dietary therapy
[14] Individuals with possible changes of life style, such as conducting a long-term travel, during the test period.
[15] 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.
[16] Individuals who have difficulty conducting tests using mobile applications.
[17] Individuals who are unable to properly store or consume the test foods due to reasons such as inability of setting the distributed freezer or non-possession of a microwave oven.
[18] Individuals who participated in other clinical studies in the past 3 months.
[19] Individuals who are or whose family is engaged in health foods of functional foods.
[20] Individuals judged inappropriate for the study by the principal.
Target sample size
40
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
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
r.shimizu@tes-h.co.jp
Sponsor or person
Institute
NISSIN FOOD PRODUCTS CO., LTD.
Institute
Department
Personal name
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
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 | 06 | Month | 07 | 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
Completed
Date of protocol fixation
| 2022 | Year | 04 | Month | 26 | Day |
Date of IRB
| 2022 | Year | 05 | Month | 09 | Day |
Anticipated trial start date
| 2022 | Year | 10 | Month | 20 | Day |
Last follow-up date
| 2022 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Due to schedule change
Management information
Registered date
| 2022 | Year | 05 | Month | 27 | Day |
Last modified on
| 2023 | Year | 08 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000054507
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