UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050804 |
|---|---|
| Receipt number | R000057863 |
| Scientific Title | Effect of chlorella intake on the condition of long-distance runners. |
| Date of disclosure of the study information | 2023/05/10 |
| Last modified on | 2024/10/10 17:47:04 |
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Basic information
Public title
Effect of chlorella intake on the condition of long-distance runners.
Acronym
Chlorella intake and long distance runners.
Scientific Title
Effect of chlorella intake on the condition of long-distance runners.
Scientific Title:Acronym
Chlorella intake and long distance runners.
Region
| Japan |
Condition
Condition
Healthy volunteer
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to examine the effects of Chlorella consumption on the condition of long distance runners.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Physical condition after one month of intake.
Key secondary outcomes
immune function
Oxidative stress
Antioxidant capacity
short-chain fatty acid
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
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
Test group
Tablets containing 4 g of chlorella are taken orally after breakfast and dinner for one month.
Interventions/Control_2
Control group
Tablets without chlorella are taken orally after breakfast and dinner for one month.
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
| 23 | years-old | >= |
Gender
Male
Key inclusion criteria
Healthy Japanese male long distance runners between the ages of 18 and 23.
Key exclusion criteria
Injuries, illnesses, and those in poor physical condition.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Kojiro |
| Middle name | |
| Last name | Ishii |
Organization
Doshisha University
Division name
Faculty of Health & Sports Science
Zip code
610-0394
Address
1-3 Tatara Miyakodani, Kyotanabe City, Kyoto
TEL
0774-65-6724
kishii@mail.doshisha.ac.jp
Public contact
Name of contact person
| 1st name | Kojiro |
| Middle name | |
| Last name | Ishii |
Organization
Doshisha University
Division name
Faculty of Health & Sports Science
Zip code
610-0394
Address
1-3 Tatara Miyakodani, Kyotanabe City, Kyoto
TEL
0774-65-6724
Homepage URL
kishii@mail.doshisha.ac.jp
Sponsor or person
Institute
Doshisha University
Institute
Department
Personal name
Funding Source
Organization
Sun Chlorella Corp.
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
Doshisha University Office of Ethics Review
Address
Karasuma-higashi-iru, Imadegawa-dori, Kamigyo-ku, Kyoto
Tel
075-251-3158
ji-rinri@mail.doshisha.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
| 2023 | Year | 05 | Month | 10 | Day |
Related information
URL releasing protocol
https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000057863
Publication of results
Unpublished
Result
URL related to results and publications
https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000057863
Number of participants that the trial has enrolled
23
Results
There was no effect on the immunity or stress response of long-distance runners after taking chlorella for about a month. In the future, it seems necessary to conduct a detailed study that takes into account the changes in propionate production in the gut caused by taking chlorella.
Results date posted
| 2024 | Year | 10 | Month | 10 | Day |
Results Delayed
| Delay expected |
Results Delay Reason
To investigate the effects of chlorella ingestion on immune and stress responses in track and field long-distance athletes, taking into account the variation in propion production in the gut.
Date of the first journal publication of results
| 2025 | Year | 03 | Month | 31 | Day |
Baseline Characteristics
Twenty-three male collegiate track and field long distance athletes were selected as subjects. The subjects lived in the same training camp and led nearly similar lifestyles.
Participant flow
Subjects were randomly divided into two groups: 12 in the placebo group and 11 in the chlorella group. Subjects were required to take the test food orally twice a day, after breakfast and dinner, for 29 days, the intervention period.
Adverse events
none
Outcome measures
physical condition
immune function
Oxidative stress
Antioxidant capacity
short-chain fatty acid
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2023 | Year | 04 | Month | 10 | Day |
Date of IRB
| 2020 | Year | 06 | Month | 26 | Day |
Anticipated trial start date
| 2023 | Year | 07 | Month | 10 | Day |
Last follow-up date
| 2023 | Year | 09 | Month | 08 | 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 | 04 | Month | 10 | Day |
Last modified on
| 2024 | Year | 10 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057863
