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 |
The Effects of Dietary Fiber-Enriched Complete Nutritional Diet on Intestinal Immune Activation and Visceral Fat.
The Effects of Dietary Fiber-Enriched Complete Nutritional Diet on Intestinal Immune Activation and Visceral Fat.
The Effects of Dietary Fiber-Enriched Complete Nutritional Diet on Intestinal Immune Activation and Visceral Fat.
The Effects of Dietary Fiber-Enriched Complete Nutritional Diet on Intestinal Immune Activation and Visceral Fat.
Japan |
No
Not applicable | Adult |
Others
NO
This study aims to effects of dietary fiber-enriched complete nutritional diet on intestinal immune activation and visceral fat.
Safety,Efficacy
[1] Indexes for visceral fat area and genetic analysis.
*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.
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
No treatment
2
Treatment
Food |
Oral intake of test meal A (4 times in a day [eating for breakfast, lunch, dinner, and snacks; 4 weeks.).
Oral intake of normal meals (keeping habit of eating before participating with the study; 4 weeks).
30 | years-old | <= |
65 | years-old | > |
Male
[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.
[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.
40
1st name | Futoshi |
Middle name | |
Last name | Nakamura |
NISSIN FOODS HOLDINGS CO., LTD.
New Business Development Division
192-0001
2100 Tobukimachi, Hachioji-shi, Tokyo
+81-42-696-7606
futoshi.nakamura@nissin.com
1st name | Ryoma |
Middle name | |
Last name | Shimizu |
TES Holdings Co., Ltd.
Administrative Department of Clinical Trials
110-0015
6F Kairaku Building 2-7-5 Higashiueno Taito-ku Tokyo 110-0015, JAPAN
+81-3-6801-8480
r.shimizu@tes-h.co.jp
NISSIN FOOD PRODUCTS CO., LTD.
NISSIN FOOD PRODUCTS CO., LTD.
Profit organization
Ueno-Asagao Clinic Ethical Review Committee
6F Kairaku Building 2-7-5 Higashiueno Taito-ku Tokyo 110-0015, JAPAN
+81-3-6240-1162
i.takahashi@tes-h.co.jp
NO
2023 | Year | 06 | Month | 07 | Day |
Unpublished
Completed
2022 | Year | 04 | Month | 26 | Day |
2022 | Year | 05 | Month | 09 | Day |
2022 | Year | 10 | Month | 20 | Day |
2022 | Year | 11 | Month | 30 | Day |
Due to schedule change
2022 | Year | 05 | Month | 27 | Day |
2023 | Year | 08 | Month | 09 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054507