UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054368 |
|---|---|
| Receipt number | R000062095 |
| Scientific Title | A study to evaluate the effect of the test food intake on stress |
| Date of disclosure of the study information | 2024/05/10 |
| Last modified on | 2025/02/03 09:08:20 |
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Basic information
Public title
A study to evaluate the effect of the test food intake on stress
Acronym
A study to evaluate the effect of the test food intake on stress
Scientific Title
A study to evaluate the effect of the test food intake on stress
Scientific Title:Acronym
A study to evaluate the effect of the test food intake on stress
Region
| Japan |
Condition
Condition
Healthy subjects
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of the test food intake on stress in healthy Japanese men and women
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
State-Trait Anxiety Inventory
Key secondary outcomes
(Secondary outcomes)
Visual Analog Scale, salivary test (cortisol), heart rate variability (LF/HF)
(Safety evaluation)
Vital signs, physical measurements (body weight and BMI), biochemical test, hematology test, urinalysis, adverse events
Base
Study type
Interventional
Study design
Basic design
Cross-over
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
Test food intake for 4 weeks
Washout (28 days or more )
Placebo food intake for 4 weeks
Interventions/Control_2
Placebo food intake for 4 weeks
Washout (28 days or more )
Test food intake for 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
| 20 | years-old | <= |
Age-upper limit
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.Japanese males and females who are between 20 and 60 years of age at the time of written informed consent.
2.Subjects who are aware of stress on a daily basis.
3.Subjects with the Beck Depression Inventory-II (BDI-II) score of < 20.
4.Subjects who are systolic blood pressure between 101 mmHg and 139 mmHg, and diastolic blood pressure between 61 mmHg and 89 mmHg.
5.Subjects who have a regular or part-time job.
6.Subjects who are fully explained the purpose and details of the study, have ability to consent, are volunteering to participate in the study with a full understanding of the explanation, and have consented to participate in the study in writing.
Key exclusion criteria
1.Subjects receiving medication or outpatient treatment for a serious disease.
2.Subjects receiving exercise or diet therapy under the supervision of a physician.
3.Subjects who may develop an allergy to the ingredient of the test food (rosemary) or aspirin.
4.Subjects with current or previous history of drug dependence or alcohol dependence.
5.Subjects who are currently seeing a doctor for the treatment of a psychiatric disorder (e.g., depression) and/or sleep disorder (e.g., insomnia, sleep apnea syndrome) or have previous history of a psychiatric disorder.
6.Subjects who have extremely irregular life rhythms due to night work, shift work, etc.
7.Subjects whose eating, sleeping, and other habits are extremely irregular.
8.Subjects who are having a very unbalanced diet.
9.Heavy users of alcohol (the mean consumption of pure alcohol is 60 g/day or more) or excessive smokers (21 cigarettes/day or more).
10.Subjects with current or previous history of a brain disease, malignancy, immunological disease, diabetes mellitus, hepatic disease (hepatitis), renal disease, cardiac disease, thyroid disease, adrenal disease, metabolic disease, or other serious diseases.
11.Subjects who use or are unable to stop using health foods, supplements (e.g., GABA, rosemary, caffeine, and theanine), and drugs that may affect stress.
12.Subjects who regularly drink energy drinks.
13.Subjects who anticipate a major change or stressful situation in their home or working environment (e.g., job change, move, marriage) from one month before screening to study completion.
14.Subjects who participated in another clinical study/research within 3 months before the date of informed consent or who plan to participate in another clinical study/research during the study period.
15.Subjects who donated more than 200 mL of whole blood, plasma, or platelets within 1 month before the date of informed consent or 400 mL within 3 months before the date of informed consent.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Satoshi |
| Middle name | |
| Last name | Fukumitsu |
Organization
NIPPN CORPORATION
Division name
Innovation Center, Central Research Laboratory
Zip code
243-0041
Address
5-1-3 Midorigaoka Atsugi Kanagawa 243-0041, Japan
TEL
046-222-6963
sfukumitsu@nippn.co.jp
Public contact
Name of contact person
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Miyazawa |
Organization
HUMA R&D CORP
Division name
Clinical Development Department
Zip code
108-0023
Address
NAKANO SPRING Bld 5F, 4-11-17 Shibaura, Minato-ku, Tokyo 108-0023 Japan
TEL
03-3431-1260
Homepage URL
rd@huma-rd.co.jp
Sponsor or person
Institute
HUMA R&D CORP
Institute
Department
Personal name
Funding Source
Organization
NIPPN CORPORATION
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
AMC Shinjuku Clinic Ethics Committee
Address
5F,SIL Shinjuku-building ,2-46-3,Kabukicho,Shinju-ku,Tokyo,160-0021,Japan
Tel
03-6709-6071
amcshinjuku@amc-clinic.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 | 05 | Month | 10 | 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
40
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
| 2024 | Year | 04 | Month | 04 | Day |
Date of IRB
| 2024 | Year | 04 | Month | 12 | Day |
Anticipated trial start date
| 2024 | Year | 05 | Month | 13 | Day |
Last follow-up date
| 2024 | Year | 09 | Month | 27 | Day |
Date of closure to data entry
| 2024 | Year | 10 | Month | 21 | Day |
Date trial data considered complete
| 2024 | Year | 10 | Month | 24 | Day |
Date analysis concluded
| 2025 | Year | 01 | Month | 28 | Day |
Other
Other related information
(Exclusion criteria continued)
16.Subjects who are currently pregnant or lactating, may become pregnant during the study period, or are planning to become pregnant during the study period.
17.Subjects who have difficulty complying with recording of each survey form.
18.Subjects whose laboratory test values or measurements at screening indicate their ineligibility to participate in the study.
19.Other Subjects who are considered ineligible for participation in the study by the investigator.
Management information
Registered date
| 2024 | Year | 05 | Month | 10 | Day |
Last modified on
| 2025 | Year | 02 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062095
