UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044449 |
|---|---|
| Receipt number | R000050763 |
| Scientific Title | Preliminary survey of iron absorption-enhancing effects caused by co-ingestion of iron medicine and lactic acid bacterium-containing food on college athletes with anemic tendency |
| Date of disclosure of the study information | 2022/06/07 |
| Last modified on | 2023/12/19 13:01:49 |
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Basic information
Public title
Preliminary survey of iron absorption-enhancing effects caused by co-ingestion of iron medicine and lactic acid bacterium-containing food on college athletes with anemic tendency
Acronym
Preliminary survey of iron absorption-enhancing effects caused by co-ingestion of iron medicine and lactic acid bacterium-containing food on college athletes with anemic tendency
Scientific Title
Preliminary survey of iron absorption-enhancing effects caused by co-ingestion of iron medicine and lactic acid bacterium-containing food on college athletes with anemic tendency
Scientific Title:Acronym
Preliminary survey of iron absorption-enhancing effects caused by co-ingestion of iron medicine and lactic acid bacterium-containing food on college athletes with anemic tendency
Region
| Japan |
Condition
Condition
Healthy male/female volunteers
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate some kind of anemia-improving effect, which could be induced by ingestion of the test food to the research volunteers
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1. Hematological test value
2. Dietary condition survey
3. Physical condition
4. Height
5. Weight
6. Body mass index
Key secondary outcomes
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
Consumption of the test tablet to the volunteer, two drops a day for 4 weeks.
Interventions/Control_2
Consumption of the placebo tablet to the volunteer, two drops a day 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
| 18 | years-old | <= |
Age-upper limit
| 25 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) Healthy Japanese volunteers belonging to the athletic clubs at Tokaigakuen university, ranging in age from 18 to 25 at informed consent.
(2) Volunteers not being under some kind of continuous medical treatment, in spite of seasonal, chronic and unexpected.
(3) Volunteers who gave informed consent to participate in this trial, after being provided with an explanation of the protocol detail.
(4) Volunteers with a fixed blood pressure--a maximal blood pressure of less than 139 mmHg, a minimal blood one of less than 89 mmHg--judging from the average of two measured values.
(5) Volunteers ranging in pulse rate from 40 to 100.
(6) Volunteers ranging in body temperature from 35.5 to 37.0.
(7) Volunteers having meals three times a day basically, without excessive eating and drinking.
(8) Volunteers with appropriate contraception during this trial.
(9) Volunteers who can understand the control matters, and observe them during this trial.
Key exclusion criteria
(1) Volunteers who have current medical history of digestive, hepatic, renal, cardiac or circulatory diseases, which would affect the absorption, distribution, metabolism and excretion of the test food.
(2) Volunteers with previous history of a major operation for digestive diseases just like surgical removal/suture of the stomach and intestines (except having polyps removed, or appendectomy).
(3) Volunteers with previous medical history of cerebral vascular disorders.
(4) Volunteers having food allergy sensitive/specific to the test food.
(5) Volunteers who are suspected of alcohol/drug dependence.
(6) Volunteers who took part in the other clinical tests within 84 days before giving informed consent to participate in this trial.
(7) Volunteers who donated 400 mL of their whole blood within the last 84 days before informed consent, or 200 mL of the blood within 28 days before the consent, or their blood component within 14 days before the consent.
(8) Pregnant or lactating women.
(9) Volunteers working on the night shift.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Yoshio |
| Middle name | |
| Last name | Nishida |
Organization
Tokaigakuen University
Division name
Professor
Zip code
468-8514
Address
2-901 Nakahira, Tenpaku-ku, Nagoya, Aichi 468-8514, Japan
TEL
052-801-1201
nishid-y@tokaigakuen-u.ac.jp
Public contact
Name of contact person
| 1st name | Atsuhisa |
| Middle name | |
| Last name | Nishimura |
Organization
Ichibiki CO., LTD.
Division name
General manager
Zip code
441-8019
Address
110-2 Kinuta, Hanada-Cho, Toyohashi, Aichi 441-8019, Japan
TEL
053-232-3631
Homepage URL
technicalcenter@ichibiki.co.jp
Sponsor or person
Institute
Tokaigakuen University
Institute
Department
Personal name
Funding Source
Organization
Ichibiki 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
Research Review Board of Tokaigakuen University
Address
2-901 Nakahira, Tenpaku-ku, Nagoya, Aichi 468-8514, Japan
Tel
052-801-1201
nishid-y@tokaigakuen-u.ac.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 | 06 | Month | 07 | 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
| 2021 | Year | 03 | Month | 15 | Day |
Date of IRB
| 2021 | Year | 03 | Month | 22 | Day |
Anticipated trial start date
| 2021 | Year | 06 | Month | 07 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 06 | Month | 06 | Day |
Last modified on
| 2023 | Year | 12 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050763
