UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058456 |
|---|---|
| Receipt number | R000066776 |
| Scientific Title | A study of the effect of continuous consumption of olive fruit extract on post-exercise fatigue |
| Date of disclosure of the study information | 2025/08/22 |
| Last modified on | 2025/08/19 10:29:33 |
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Basic information
Public title
A study of the effect of continuous consumption of olive fruit extract on post-exercise fatigue
Acronym
A study of the effect of continuous consumption of olive fruit extract on post-exercise fatigue
Scientific Title
A study of the effect of continuous consumption of olive fruit extract on post-exercise fatigue
Scientific Title:Acronym
A study of the effect of continuous consumption of olive fruit extract on post-exercise fatigue
Region
| Japan |
Condition
Condition
Healthy subjects
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effects of one week of continuous consumption of the test food on post-exercise fatigue in Japanese men and women between the ages of 30 and 65.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Fatigue of visual analogue scale
Key secondary outcomes
(Secondary outcomes)
Autonomic Nervous System (LF/HF),CK,lactic acid,High sensitivity IL-6,d-ROMs
(Safety evaluation)
Vital signs,body measurements(weight,BMI),blood biochemistry,hematology,Urinalysis,adverse events
Base
Study type
Interventional
Study design
Basic design
Cross-over
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
Prevention
Type of intervention
| Food |
Interventions/Control_1
Intake of active food-Washout period-Intake of placebo food
Interventions/Control_2
Intake of placebo food-Washout period-Intake of active food
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
| 30 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1.Japanese men and women between 30 and 65 years of age at the time of obtaining written informed consent.
2.Subjects who are not in the habit of exercising (not meeting the following definition)
*Subjects who have been exercising at least twice a week for at least 30 minutes each time for one year.
3.Subjects who have been fully explained the purpose and contents of the study ,are capable of consenting, fully understand the content ,and voluntarily volunteer to participate in the study and agree to participate in the study in writing.
Key exclusion criteria
1.Subjects who are taking medication or under medical treatment.
2.Subjects who are under exercise therapy or dietetic therapy.
3.Subjects who have developed allergies as for the foods test.
4.Subjects with current or history of drug dependence or alcohol dependence.
5.Subjects who are hospitalized for mental disorders (depression, etc.) or sleep disorders(insomnia, sleep apnea, etc.), or have a history of mental disorders in the past.
6.Subjects with smoking habit.(Have smoked within the last year.)
7.Subjects with irregular life rhythms due to night shifts or shift work.
8.Subjects with heavy alcohol consumption.(Subjects whose average daily net alcohol intake exceeds approximately 60g)
9.Subjects with extremely irregular lifestyle habits such as eating and sleeping.
10.Subjects who have an extremely unbalanced diet.
11.Subjects with serious current or previous illnesses such as brain disease, malignancy, immunological disease, diabetes, liver disease (hepatitis),renal disease, cardiac disease, thyroid disease, adrenal gland disease, tendon disease, joint contracture, orthopedic disease, or other metabolic diseases.
12.Subjects who have suffered a serious injury to the locomotor organs such as fracture, tendon rupture, or flesh tear within the past year, or who have difficulty performing exercise load due to pain or discomfort in the locomotor organs.
13.Subjects using health foods, supplements, and medications that reduce fatigue.
14.Subjects who have participated in other clinical trials (research) within 3 months from the date of consent acquisition or who plan to participate in other clinical trials (research) during the trial period.
15.Subjects who have collected 200mL of blood or donated more than 400mL of blood within 3months from the date of consent acquisition.
16.Subjects who are planning to get pregnant after the day of informed consent or is currently pregnant and lactating.
Target sample size
32
Research contact person
Name of lead principal investigator
| 1st name | Kyoko |
| Middle name | |
| Last name | Shimazu |
Organization
NIPPN CORPORATION
Division name
Central Laboratory Innovation Center
Zip code
243-0041
Address
5-1-3, Midorigaoka, Atsugi, Kanagawa, Japan
TEL
046-222-6963
k-shimazu@nippn.co.jp
Public contact
Name of contact person
| 1st name | Masao |
| Middle name | |
| Last name | Matsuoka |
Organization
M&I Science CORP.
Division name
Clinical Development Department
Zip code
530-0001
Address
Pacific Marks Nishi Umeda 4F, 2-6-20, Umeda, Kita-ku, Osaka-Shi, Osaka, Japan
TEL
06-7878-6780
Homepage URL
m.matsuoka@mis21.co.jp
Sponsor or person
Institute
others
Institute
Department
Personal name
Funding Source
Organization
others
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 Review Committee, Tokyo Shinjuku Clinic
Address
SIL Shinjuku Buildings 5F, 2-46-3, Kabukicho, Shinjuku-ku, Tokyo,Japan
Tel
03-6709-6071
irb@ml.taifukukai.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
| 2025 | Year | 08 | Month | 22 | 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
Open public recruiting
Date of protocol fixation
| 2025 | Year | 05 | Month | 30 | Day |
Date of IRB
| 2025 | Year | 06 | Month | 13 | Day |
Anticipated trial start date
| 2025 | Year | 08 | Month | 18 | Day |
Last follow-up date
| 2025 | Year | 11 | Month | 21 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
(Exclusion criteria continued)
17.Subjects who have difficulty observing records on various survey forms.
18.Subjects who are judged as an inappropriate candidate according to the screening data.
19.Subjects who are considered as an inappropriate candidate by the doctor in charge.
Management information
Registered date
| 2025 | Year | 07 | Month | 14 | Day |
Last modified on
| 2025 | Year | 08 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066776
