UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031907 |
|---|---|
| Receipt number | R000036429 |
| Scientific Title | A confirmatory study examining effects of continuous intake of test food on healthy adults |
| Date of disclosure of the study information | 2018/03/26 |
| Last modified on | 2024/05/27 15:03:24 |
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Basic information
Public title
A confirmatory study examining effects of continuous intake of test food on healthy adults
Acronym
A confirmatory study examining effects of continuous intake of test food on healthy adults
Scientific Title
A confirmatory study examining effects of continuous intake of test food on healthy adults
Scientific Title:Acronym
A confirmatory study examining effects of continuous intake of test food on healthy adults
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine effects on muscle mass, bone density, cognitive function, body composition, and QOL in postmenopausal women aged 50 to 69 after 24 weeks of continuous intake of test food.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
muscle mass, bone density
Key secondary outcomes
Markers in blood (osteocalcin, TRACP-5b, BDNF, FSH, LH, estrone, HDL-C, LDL-C, TC, and TG) and urine (deoxypyridinoline), scores of Cognitrax, vital signs, QOL questionnaire (SF-36, bowel habit questionnaire)
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
Take 4 capsules of test food t.i.d.
Interventions/Control_2
Take 4 capsules of placebo t.i.d.
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
| 50 | years-old | <= |
Age-upper limit
| 69 | years-old | >= |
Gender
Female
Key inclusion criteria
1.Age:50 to 69 years old
2.Gender:Women
3.Healthy adults (We define "healthy adults" as those who currently have neither severe organ damage nor a particular disease, who currently do not receive treatment associated with those disorders, and who currently do not receive any kind of drug treatment. We judge whether or not a candidate meets this definition according to the self-report submitted when a clinical trial is commenced)
4.Postmenopausal women
5.Those who can give their written informed consent
Key exclusion criteria
1.Those who currently receive continuous drug treatment (except for drugs that are taken as needed)
2.Those who currently undergo dietary or exercise therapy under the direction of physicians
3.Those with a past medical history of any of the following: hepatic disease, severe disorder (kidney, endocrine, cardiovascular, gastrointestinal, and lung diseases, and blood and metabolic disorders), or complications
4.Those with a past medical history of mental disorder (such as depression)
5.Those with a past and current medical history of drug or food allergy
6.Those who work night shifts or irregular shifts
7.Those who currently take health food and supplements (except for those who can stop taking them after they have signed an informed consent form)
8.Smokers
9.Those who currently take warfarin product (such as Warfarin, Warlin, Arefarin, Warfarin K, etc.)
10.Those who have metallic orthopedic implants
11.Those who underwent barium enema in 3 days before the commencement of this clinical trial
12.Those who have done fingernail or toenail designs on the day of a bone density test
13.Those who are participating in other clinical trials or participated in the past 1 month and then took their test products
14.Any other conditions, in the opinion of the principal investigator, those who were determined to be unsuitable for participation in this clinical trial
Target sample size
66
Research contact person
Name of lead principal investigator
| 1st name | Kiyoshi |
| Middle name | |
| Last name | Nakamura |
Organization
Higashi Koganei Sakura Clinic
Division name
Chairman
Zip code
184-0011
Address
4-37-26,Higashicho,Koganei-shi,Tokyo,Japan
TEL
042-382-3081
clinical-trial@imeqrd.co.jp
Public contact
Name of contact person
| 1st name | Yoshitada |
| Middle name | |
| Last name | Hira |
Organization
IMEQRD Co., Ltd.
Division name
Planning and Sales Department
Zip code
104-0061
Address
6-2-1 Ginza Chuo-ku Tokyo Japan
TEL
03-6704-5968
Homepage URL
clinical-trial@imeqrd.co.jp
Sponsor or person
Institute
IMEQRD Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
euglena Co.Ltd
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Suda Clinic institutional review board
Address
2-8-14,Takadanobaba,Shinjyuku,Tokyo
Tel
03-6704-5968
jimukyoku@imeqrd.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
| 2018 | Year | 03 | Month | 26 | 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
| 2018 | Year | 02 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 04 | Month | 21 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 03 | Month | 26 | Day |
Last modified on
| 2024 | Year | 05 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036429
