UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044019 |
|---|---|
| Receipt number | R000050261 |
| Scientific Title | Verification of the effect of test food intake on the intestinal environment for the elderly |
| Date of disclosure of the study information | 2022/07/20 |
| Last modified on | 2023/05/17 13:54:24 |
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Basic information
Public title
Verification of the effect of test food intake on the intestinal environment for the elderly
Acronym
Verification of the effect of test food intake on the intestinal environment for the elderly
Scientific Title
Verification of the effect of test food intake on the intestinal environment for the elderly
Scientific Title:Acronym
Verification of the effect of test food intake on the intestinal environment for the elderly
Region
| Japan |
Condition
Condition
Healthy subjects
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Examining the effect on the intestinal environment by ingesting test foods for Japanese men and women over 70 years old
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Stool test(Intestinal flora, short chain fatty acids, metabolome analysis)
Key secondary outcomes
(Secondary outcomes)
Defecation survey,SF-8 Japanese version,The Philadelphia Geriatric Center Morale Scale
(Safety evaluation)
Vital signs, physical measurement, blood biochemistry, hematology, urinalysis, adverse events
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) 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
6-weeks intake of the test food
Interventions/Control_2
6-weeks intake of the placebo food
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
| 70 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Japanese men and women aged 70 and over at the time of obtaining written consent.
2.Subject with BMI>=18.5 and <25.
3.Subject who has received sufficient explanation of the purpose and content of the research, have the ability to consent, voluntarily volunteered to participate in the examination after understanding it well, and agreed to participate in the examination in writing.
Key exclusion criteria
1.Subject who is taking medication or under medical treatment.However, if it falls under any of the following diseases, it can be incorporated as necessary.Eye disease, hypertension, dyslipidemia, hyperuricemia, osteoporosis
2.Subject who is under exercise therapy or dietetic therapy.
3.Subject who may develop allergies due to test foods.
4.Subject with current or history of drug or alcohol dependence.
5.Subject who is out of the hospital due to mental disorders (depression, etc.) or sleep disorders, or who have a history of mental illness in the past
6.Subject with irregular life rhythms due to night shifts or shift work
7.Subject who has extremely irregular lifestyle habits such as eating and sleeping
8.Subject who has an extremely unbalanced diet.
9.Serious diseases such as brain disease, malignant tumor, immune disease, diabetes, liver disease (hepatitis), renal disease, heart disease, thyroid disease, adrenal disease, and other serious current or past diseases such as metabolic disease those who have.
10.Subject who uses health foods, supplements, and medicines (intestinal regulators, antibiotics, laxatives, etc.) that affect the study.
(Continue to other related information)
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Daisuke |
| Middle name | |
| Last name | Ochitani |
Organization
HUMA R&D CORP
Division name
Public Relations Department
Zip code
108-0014
Address
Round Cross Tamachi 10F 5-31-19 Shiba Minato-ku Tokyo 108-0014 Japan
TEL
03-3431-1260
ochitani@huma-rd.co.jp
Public contact
Name of contact person
| 1st name | Daisuke |
| Middle name | |
| Last name | Ochitani |
Organization
HUMA R&D CORP
Division name
Public Relations Department
Zip code
108-0014
Address
Round Cross Tamachi 10F 5-31-19 Shiba Minato-ku Tokyo 108-0014 Japan
TEL
03-3431-1260
Homepage URL
ochitani@huma-rd.co.jp
Sponsor or person
Institute
HUMA R&D CORP
Institute
Department
Personal name
Funding Source
Organization
Asahi Quality & Innovations, 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
NISHI-UMEDA Clinic for Asian Medical Collaboration Clinical Research Institutional Review Board
Address
West Umeda Building 3F 3-3-45 Umeda Kita-ku Osaka Japan,530-0001
Tel
06-4797-5660
jimukyoku@amc-clinc.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
| 2022 | Year | 07 | Month | 20 | 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
60
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
| 2021 | Year | 04 | Month | 08 | Day |
Date of IRB
| 2021 | Year | 04 | Month | 22 | Day |
Anticipated trial start date
| 2021 | Year | 04 | Month | 26 | Day |
Last follow-up date
| 2021 | Year | 07 | Month | 20 | Day |
Date of closure to data entry
| 2021 | Year | 09 | Month | 01 | Day |
Date trial data considered complete
| 2021 | Year | 09 | Month | 13 | Day |
Date analysis concluded
| 2022 | Year | 12 | Month | 31 | Day |
Other
Other related information
(Exclusion criteria continued)
11.Subject who regularly uses carbonated beverages (including carbonated alcoholic beverages) and other carbonated beverages, and hydrogen water and other functional drinking water for 4 days or more a week.
12.Subject who has participated in other clinical trials (research) within 3 months from the date of consent acquisition, or those who plan to participate in other clinical trials (research) during the trial period.
13.Subject who has collected more than 200 mL of blood or donated more than 400 mL of blood within 1 month or 3 months from the date of consent acquisition.
14.Subject who has difficulty observing records on various survey forms.
15.Persons judged to be inappropriate as subjects based on clinical laboratory test values and measured values at the time of SCR
16.Subject who has diarrheal stools that are difficult to collect
17.Self-reported bowel movements less than twice a week
18.Subject who is prone to diarrhea and have a weak gastrointestinal tract
19.Alcohol polydipsia (drinkers with an average weekly pure alcohol intake of more than 60 grams / day)
20.Others who are judged by the investigator to be inappropriate as subjects
Management information
Registered date
| 2021 | Year | 04 | Month | 23 | Day |
Last modified on
| 2023 | Year | 05 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050261
