UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047002 |
|---|---|
| Receipt number | R000053589 |
| Scientific Title | An exploratory study on the improvement effect of continuous intake of test food on anemia-related biomarkers. -a open-label, parallel-group comparison trial- |
| Date of disclosure of the study information | 2022/02/25 |
| Last modified on | 2024/05/27 17:58:00 |
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Basic information
Public title
An exploratory study on the improvement effect of continuous intake of test food on anemia-related biomarkers. -a open-label, parallel-group comparison trial-
Acronym
An exploratory study on the improvement effect of continuous intake of test food on anemia-related biomarkers.
Scientific Title
An exploratory study on the improvement effect of continuous intake of test food on anemia-related biomarkers. -a open-label, parallel-group comparison trial-
Scientific Title:Acronym
An exploratory study on the improvement effect of continuous intake of test food on anemia-related biomarkers.
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to investigate the effect and safety of single- and continuous-intake of test food for 4-weeks on anemia-related biomarkers in healthy females with awareness of anemia aged between 20 and less than 50 years old.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Blood hemoglobin levels, RBC counts, hematocrit levels, blood transferrin levels, UIBC, TIBC, serum Fe, reticulocyte counts, blood ferritin levels
Blood erythropoietin kinetics after the single intake of the test food
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Take the test food alone before or after breakfast.
Interventions/Control_2
No treatment.
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
| 50 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Aged between 20 and less than 59.
2. Japanese females.
3. Normal menstrual periods.
4. Have awareness of anemia
5. Can use smartphones or PCs to input an electronic diary.
6. Received sufficient explanation for the objective and summary of the study, and voluntarily volunteered to the study with the agreement of informed consent.
Key exclusion criteria
1. Currently undergoing treatment for any disease, or receive medical treatment such as medical drugs or traditional Chinese medicines.
2. Receiving nutritional and exercise therapy under medical doctors.
3. Have severe diseases or a history of severe diseases.
4. Have been received GI tract surgery (except for appendicitis).
5. Have currently been taking commercially available drugs, quasi-drug products, foods, or supplements with any functional claims. However, can discontinue taking these drugs/foods during the trial period is acceptable to join the study.
6. Have an allergy to drugs, or foods.
7. Planning extremely change lifestyle (such as diet, sleep, or exercise) during the study period.
8. Work in shift and night shift.
9. Planning travel to foreign countries during the study period.
10. Currently pregnant or breastfeeding, or planning to pregnant during the study period.
11. Take more than 60 g alcohol/day.
12. Smoker (more than 21 cigarettes/day).
13. Donated blood (including plasma or serum) more than 200 mL within three months before the study.
14. Individuals who joined other clinical trials from one month before the trial, individuals who have currently been joined other clinical trials, and also individuals who are planning to join other clinical trials during the trial.
15. Unsuitable for this study, that judged by the principal investigator.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Mario |
| Middle name | Jose Villegas |
| Last name | Yata |
Organization
FRUTA FRUTA, Inc.
Division name
Sales Headquaters
Zip code
102-0073
Address
Agroforestry Bldg 3-2-28 Kudankita, Chiyoda-ku, Tokyo, 102-0073, Japan.
TEL
03-6272-9081
mario@frutafruta.com
Public contact
Name of contact person
| 1st name | Hirokuni |
| Middle name | |
| Last name | Kayama |
Organization
IMEQRD Co, Ltd.
Division name
Planning and Sales Department
Zip code
104-0061
Address
Daiwa Ginza Bld. 3F, 6-2-1, Ginza, Chuo-ku, Tokyo, Japan
TEL
0367045968
Homepage URL
https://imeqrd.co.jp/
clinical-trial@imeqrd.co.jp
Sponsor or person
Institute
IMEQRD Co, Ltd.
Institute
Department
Personal name
Funding Source
Organization
FRUTA FRUTA, Inc.
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
Suda Clinic institutional review board
Address
2-8-14,Takadanobaba,Shinjyuku,Tokyo
Tel
0367045968
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
| 2022 | Year | 02 | Month | 25 | 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
| 2022 | Year | 02 | Month | 22 | Day |
Date of IRB
| 2022 | Year | 02 | Month | 25 | Day |
Anticipated trial start date
| 2022 | Year | 03 | Month | 26 | Day |
Last follow-up date
| 2022 | Year | 04 | Month | 24 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 02 | Month | 25 | 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=R000053589
