UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058589 |
|---|---|
| Receipt number | R000066990 |
| Scientific Title | An Exploratory, Double-Blind, Placebo-Controlled, Parallel-Group Study on the Effects of Oligonol Supplementation on High-Altitude Adaptation in Female Track and Field Athletes (OLIFAT study) |
| Date of disclosure of the study information | 2025/07/28 |
| Last modified on | 2025/07/24 17:50:36 |
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Basic information
Public title
An Exploratory Study on the Effects of Short-Term Oligonol Supplementation on High-Altitude Training Adaptation in Female Long-Distance Runners
Acronym
OLIFAT study
Scientific Title
An Exploratory, Double-Blind, Placebo-Controlled, Parallel-Group Study on the Effects of Oligonol Supplementation on High-Altitude Adaptation in Female Track and Field Athletes (OLIFAT study)
Scientific Title:Acronym
OLIFAT study
Region
| Japan |
Condition
Condition
Female Athletes
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study examines the potential physiological benefits of short-term Oligonol supplementation in healthy female long-distance runners undergoing high-altitude residence and training. Oligonol is a low-molecular-weight polyphenol derived from lychee. Specifically, the study examines its impact on anaemia-related biomarkers, psychophysiological stress and inflammatory responses, with the aim of evaluating its potential as a nutritional recovery and conditioning strategy under hypoxic conditions.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Ferritin concentrations in blood before and after 9-day Oligonol supplementation
Key secondary outcomes
All measurements were conducted before and after 9-day Oligonol supplementation, including:
1. Anemia-related parameters (Reticulocyte count, Total protein, Hemoglobin, Hematocrit, Red blood cell count, Mean corpuscular volume, Mean corpuscular hemoglobin concentration, Total iron-binding capacity, Serum iron)
2. C-reactive protein (CRP)
3. Oxidative stress marker: d-ROMs test
4. Antioxidant capacity: BAP test
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
Educational,Counseling,Training
Type of intervention
| Food |
Interventions/Control_1
Participants will orally take one hard capsule containing 100 mg of Oligonol after breakfast and one after dinner (2 capsules per day), with water or lukewarm water. The supplementation period will be 9 days.
Interventions/Control_2
Participants will orally take one hard capsule containing dextrin (placebo) after breakfast and one after dinner (2 capsules per day), with water or lukewarm water. The supplementation period will be 9 days.
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
| Not applicable |
Gender
Female
Key inclusion criteria
(1) Written informed consent has been obtained from the participant.
(2) The participant is a healthy female aged 18 years or older.
(3) The participant does not plan to take any new supplements or health foods during the study period.
Key exclusion criteria
(1) Individuals with a current or past history of allergy to any component contained in the study food.
(2) Current smokers or individuals with a history of smoking within the past three months.
(3) Individuals who are pregnant, lactating, possibly pregnant, or planning to become pregnant or breastfeed during the study period.
(4) Individuals with gastrointestinal disorders that may impair nutrient absorption, such as malabsorption syndrome or a history of gastrectomy.
(5) Individuals receiving ongoing pharmacological treatment for any medical condition, including endocrine disorders.
(6) Individuals currently participating in another clinical or observational study, or planning to participate in one during the study period.
(7) Individuals deemed inappropriate for study participation by the principal investigator.
Target sample size
28
Research contact person
Name of lead principal investigator
| 1st name | Masako |
| Middle name | |
| Last name | Ota |
Organization
Toyo University
Division name
Faculty of Health and Sports Sciences
Zip code
115-8650
Address
HELSPO HUB-3,1-7-11, Akabanedai, Kita-ku, Tokyo
TEL
03-5924-2825
masako@toyo.jp
Public contact
Name of contact person
| 1st name | Naho |
| Middle name | |
| Last name | Serizawa |
Organization
Toyo University
Division name
Faculty of Health and Sports Sciences
Zip code
115-8650
Address
HELSPO HUB-3,1-7-11, Akabanedai, Kita-ku, Tokyo
TEL
03-5924-2819
Homepage URL
serizawa@toyo.jp
Sponsor or person
Institute
Toyo University
Institute
Department
Personal name
Funding Source
Organization
Amino Up 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
Ethics Committee of Nonprofit Organization TACTICS
Address
INFAS, Kita 2-jo Nishi 9-chome, Chuo-ku, Sapporo, Japan
Tel
011-281-0757
yuriko.iw@gmail.com
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
| 2025 | Year | 07 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 07 | Month | 22 | Day |
Date of IRB
| 2025 | Year | 07 | Month | 22 | Day |
Anticipated trial start date
| 2025 | Year | 08 | Month | 16 | Day |
Last follow-up date
| 2025 | Year | 09 | 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
| 2025 | Year | 07 | Month | 24 | Day |
Last modified on
| 2025 | Year | 07 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066990
