UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052020 |
|---|---|
| Receipt number | R000059345 |
| Scientific Title | Clinical trial to mineral absorption effect of test food |
| Date of disclosure of the study information | 2023/08/28 |
| Last modified on | 2024/07/08 10:24:05 |
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Basic information
Public title
Clinical trial to mineral absorption effect of test food
Acronym
Clinical trial to mineral absorption effect of test food
Scientific Title
Clinical trial to mineral absorption effect of test food
Scientific Title:Acronym
Clinical trial to mineral absorption effect of test food
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect of mineral absorption ingestion of test food for 8 weeks of continuous intake, using placebo as a control
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1.urine calcium
2.urine magnesium
3.urine iron
at before ingestion and 8weeks ingestion period
Key secondary outcomes
Defecation frequency of before ingestion and 8 weeks ingestion period
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
Ingestion of test food for 8 weeks
Interventions/Control_2
Ingestion of placebo 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
| 18 | years-old | <= |
Age-upper limit
| 64 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.Healthy males and females between the ages of 18 and 64
2.Subjects who can carry out clinical research procedures as prescribed
3.Subjects who can understand the purpose and content of this study and voluntarily agree to participate in this study
Key exclusion criteria
Subjects
1.who undergoing hormone replacement therapy
2.who have a disease that is being treated or who have a disease that is deemed to require treatment
3.who are undergoing medical treatment or have a medical history of malignant tumor, heart failure or myocardial kidney disease etc. infarction
4.who regularly use related to lactic acid bacteria, vitamins, and minerals, health foods, pharmaceuticals, quasi-drugs, over-the-counter drugs, nutritional supplements, and minerals and continue to take them during the study period
5.who regularly use health foods or medicines that promote or inhibit the absorption of calcium, magnesium, and iron
6.who routinely consume foods fortified with calcium, magnesium, and iron
7. who regularly use pharmaceuticals
8.who have a tendency toward diarrhea
9.who have been diagnosed with hyperhidrosis or who are aware of hyperhidrosis
10.who tend to urinate frequently or who urinate extremely infrequently
11.who have possibilities for emerging allergy onset food allergies
12. who regularly engaged in exercise or activities that involve excessive sweating
13.who have physical labor in perspiration
14.who night and day shift worker or manual laborer
15.women with irregular menstruation
16.who drink a lot
17.who with an unbalanced diet or those with irregular eating habits
18.who cannot control their room temperature
19.who cannot drink the prescribed amount of water on the day of the examination
20.who are judged as unsuitable due to lifestyle questionnaire
21.who are judged as unsuitable for the study based on the results of clinical and physical examination screening test
22.who have participated in other clinical study within three months before the screening test or who intend to participate in the study period
23.who are planned to become pregnant or are pregnant or lactating
24.who are judged as unsuitable for the study by the investigator for other reason
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Naoki |
| Middle name | |
| Last name | Nakamura |
Organization
IKEDA FOOD RESEARCH CO.,LTD
Division name
Food Science and Technology Institute
Zip code
721-0956
Address
95-7, Minooki-cho, Fukuyama-city, Hiroshima, Japan
TEL
084-957-3411
n.nakamura@ikedatohka.co.jp
Public contact
Name of contact person
| 1st name | Kei |
| Middle name | |
| Last name | Yasui |
Organization
EP Mediate Co., Ltd.
Division name
Foods Department, Trial Planning
Zip code
162-0821
Address
Kagurazaka AK Bldg., 1-8, Tsukudo-cho, Shinjuku-ku, Tokyo
TEL
080-7710-1158
Homepage URL
yasui.kei475@eps.co.jp
Sponsor or person
Institute
EP Mediate Co., Ltd
Institute
Department
Personal name
Funding Source
Organization
IKEDA FOOD RESEARCH 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
Medical Station Clinic Research Ethics Committee
Address
3-12-8, Takaban, Meguroku, Tokyo
Tel
03-6452-2712
nakagawa.akiko297@eps.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
| 2023 | Year | 08 | Month | 28 | 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 | 02 | Month | 16 | Day |
Date of IRB
| 2023 | Year | 02 | Month | 16 | Day |
Anticipated trial start date
| 2023 | Year | 09 | Month | 03 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 15 | 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 | 08 | Month | 28 | Day |
Last modified on
| 2024 | Year | 07 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059345
