UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053061 |
|---|---|
| Receipt number | R000060546 |
| Scientific Title | A study of the effect of intake of milk-derived products on stress relief -A randomized, double-blind, placebo-controlled, parallel-group comparative test- |
| Date of disclosure of the study information | 2024/10/30 |
| Last modified on | 2024/07/05 09:11:56 |
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Basic information
Public title
A study of the effect of intake of milk-derived products on stress relief -A randomized, double-blind, placebo-controlled, parallel-group comparative test-
Acronym
A study of the effect of intake of milk-derived products on stress relief
Scientific Title
A study of the effect of intake of milk-derived products on stress relief -A randomized, double-blind, placebo-controlled, parallel-group comparative test-
Scientific Title:Acronym
A study of the effect of intake of milk-derived products on stress relief
Region
| Japan |
Condition
Condition
Healthy subjects who are stressed and have problems such as fatigue (Non-chronic, non-illness)
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of intake of milk-derived products on stress relief.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluation of stress by POMS2 and Visual analog scale questionnaire
Key secondary outcomes
1.Salivary IgA
2.Salivary Chromogranin A
3.Salivary sialic acid levels
4.Salivary flow rate
5.Serum BDNF levels
6.Serum sialic acid levels
7.Serum HHV6 levels
8.Serum TGF-B
9.Fecal organic acids
10.Fecal IgA levels
11.Gut microbiota
12.NK cell activity
13.Bowel habit
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
Treatment
Type of intervention
| Food |
Interventions/Control_1
Oral intake of the test foods (6 capsules in a day for 8 weeks)
Interventions/Control_2
Oral intake of the placebo foods (6 capsules in 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
| 20 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1.Japanese healthy adults aged 20 to 65 years old who are stressed
2.Those who get a detailed briefing on this project in advance, can understand the contents, agree with its purpose, and can submit a written consent
3.Subjects who are judged as suitable for the study
Key exclusion criteria
1.Individuals who are, or are under treatment or have a history of serious disease or/and thyroid gland disease, adrenal gland disease, and/or metabolic disorder
2.Subjects who have a disease on treatment or are judged to that medical treatment are necessary by the doctor
3.Subjects who are unable to stop eating foods containing live bacteria during the research period
4.Subjects who has taken health foods, supplements, or drugs that may affect fatigue relief
5.Night and day shift worker or manual laborer
6.Subject who score of Beck Depression Inventory is 20 points or more
7.Subjects diagnosed with chronic fatigue syndrome
8.Subjects who are under treatment or a history of mental illness, sleep apnea syndrome, chronic fatigue syndrome
9.Subjects with VAS of 0 mm
10.Subjects who are unable to stop drinking from 2 days before each test
11.Subject who smokes regularly om a daily (more than 20 cigarettes per day)
12.Subject who has routinely taken large amounts of drinks containing a lot of caffeine (equivalent to 7 cups of coffee /day or more)
13.Subjects having possibilities for emerging allergy related to the study
14.Subjects who are planned to become pregnant
15.Subject who is judged as an inappropriate candidate according to the screening data
16.Subject who has blood drawn 200mL within the past 1 months or 400mL within the past 3 months from the day of the consent acquisition
17.Subject who has or had a history of either medicine or alcohol dependence syndrome
18.Subject who has participated in other clinical studies within the past 3 months from the day of the consent acquisition or who is planning to participate in other clinical studies during the current study
19.Subjects who are a history of xerostomia
20.Subjects who are judged as unsuitable for the study by the investigator for other reason
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Yoshitaka |
| Middle name | |
| Last name | Iwama |
Organization
Nihonbashi Cardiology Clinic
Division name
Director
Zip code
103-0001
Address
Kyodo Bldg. #201, 13 - 4 Nihonbashi Kodenm acho, Chuo-ku, Tokyo
TEL
03-5641-4133
yiwama@well-sleep.jp
Public contact
Name of contact person
| 1st name | Eiji |
| Middle name | |
| Last name | Yoshikawa |
Organization
KSO Corporation
Division name
Sales department
Zip code
105-0023
Address
Shibaura Omodaka Building 7F, 1-9-7 Shibaur a, Minato-ku, Tokyo
TEL
03-3452-7733
Homepage URL
eigyou27@kso.co.jp
Sponsor or person
Institute
KSO Corporation
Institute
Department
Personal name
Funding Source
Organization
MEGMILK SNOW BRAND 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
Ethical Committee of Kobuna Orthopedics Clinic
Address
5-656-17Joutou-machi,Maebashi-shi,Gunma
Tel
027-212-5608
sagawa@mc-connect.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
| 2024 | Year | 10 | Month | 30 | 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 | 06 | Month | 08 | Day |
Date of IRB
| 2023 | Year | 06 | Month | 08 | Day |
Anticipated trial start date
| 2023 | Year | 10 | Month | 14 | Day |
Last follow-up date
| 2024 | Year | 01 | Month | 10 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2024 | Year | 06 | Month | 10 | Day |
Other
Other related information
Management information
Registered date
| 2023 | Year | 12 | Month | 11 | Day |
Last modified on
| 2024 | Year | 07 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060546
