UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053187 |
|---|---|
| Receipt number | R000060695 |
| Scientific Title | Verification study on the immunomodulatory effects of continuous consumption of dairy products: a randomized, placebo-controlled, double-blind, parallel-group comparison study |
| Date of disclosure of the study information | 2024/01/12 |
| Last modified on | 2025/04/07 10:48:01 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Verification on the immunomodulatory effects of continuous consumption of dairy products
Acronym
Verification on the immunomodulatory effects of continuous consumption of dairy products
Scientific Title
Verification study on the immunomodulatory effects of continuous consumption of dairy products:
a randomized, placebo-controlled, double-blind, parallel-group comparison study
Scientific Title:Acronym
Verification study on the immunomodulatory effects of continuous consumption of dairy products
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the effect of continuous consumption of dairy products on immune function in healthy adults.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Immune function
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Consume test food once a day for 8 weeks.
Interventions/Control_2
Consume placebo food once a day for 8 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
| 35 | years-old | <= |
Age-upper limit
| 60 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1.Healthy Japanese male and female aged 35-59 years.
2.Subjects experiencing fatigue on a daily basis.
3.Subjects prone to catching colds.
4.Subjects who can understand the purpose and the contents of this study and given written consent to participate in this study.
Key exclusion criteria
1.Subjects suffering from, undergoing treatment for, or with a history of diabetes, renal or hepatic disease, heart disease or other serious illness, thyroid disease, adrenal disease, or other metabolic diseases.
2.Subjects with chronic diseases and use drug regularly.
3.Subjects with a history or current history of drug or alcohol dependence.
4.Subjects who have been regularly using (more than three days a week) food containing lactic acid bacteria such as yogurt, lactic acid bacteria beverages, food for specified health uses, food with nutrient function claims, health food or supplements.
5.Subjects whose average daily alcohol consumption exceeds 40 g per day (1,000 mL of alcohol drink at 5% alcohol).
6.Subjects who are unable to abstain from alcohol for one day prior to each inspection day.
7.Subjects who have habit of smoking.
8.Subjects who have hay fever.
9.Subjects with a history of gastrointestinal diseases affecting digestion and absorption and gastrointestinal surgery (except appendicitis).
10.Subjects with dental or oral problems that involve bleeding and are the symptoms likely to continue during the study period.
11.Subjects who scheduled for vaccination during the study period.
12.Subjects whose hemoglobin levels are below 12 g/dl for male and 11 g/dl for female in the blood test at the time of the screening test.
13.Subjects who test positive for infectious diseases at the time of the screening test.
14.Subjects who are pregnant, planning or wishing to be pregnant during the study period, and are breastfeeding.
15.Subjects prone to diarrhea when consuming dairy products.
16.Subjects with food allergy.
17.Subjects who have participated in other clinical studies in the month prior to the screening test, and plan or wish to participate in other clinical studies during the study period.
18.Subjects who are judged as unsuitable for this study by the investigator for other reasons.
Target sample size
140
Research contact person
Name of lead principal investigator
| 1st name | Takayuki |
| Middle name | |
| Last name | Toshimitsu |
Organization
Meiji Co., Ltd
Division name
R&D division
Zip code
192-0919
Address
1-29-1 Nanakuni, Hachiouji, Tokyo, Japan
TEL
81-42-632-5842
toshihiro.sashihara@meiji.com
Public contact
Name of contact person
| 1st name | Eiji |
| Middle name | |
| Last name | Yoshikawa |
Organization
KSO Corporation
Division name
Clinical Trial Management department
Zip code
105-0023
Address
1-9-7, Shibaura, Minato-ku, Tokyo, the 7th floor of Shibaura omodaka building
TEL
81-3-3452-7733
Homepage URL
eigyou27@kso.co.jp
Sponsor or person
Institute
Meiji Co., Ltd
Institute
Department
Personal name
Funding Source
Organization
Meiji 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
Ethnical Committee of Nihonbashi Cardiology Clinic
Address
Kyodo Bldg. #201, 13-4 Nihonbashi Kodenmacho, Chuo-ku, Tokyo
Tel
81-3-5641-4133
niho-jimucho@well-sleep.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
| 2024 | Year | 01 | Month | 12 | 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
| 2023 | Year | 09 | Month | 20 | Day |
Date of IRB
| 2023 | Year | 09 | Month | 20 | Day |
Anticipated trial start date
| 2024 | Year | 01 | Month | 13 | Day |
Last follow-up date
| 2024 | Year | 04 | Month | 14 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 12 | Month | 21 | Day |
Last modified on
| 2025 | Year | 04 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060695
