UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051018 |
|---|---|
| Receipt number | R000058162 |
| Scientific Title | Effect of continuous ingestion of seabuckthorn juice on iron metabolism and vascular function: A randomized, double-blind, placebo-controlled crossover study |
| Date of disclosure of the study information | 2023/05/09 |
| Last modified on | 2025/02/06 10:55:57 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Effect of continuous ingestion of seabuckthorn juice on iron metabolism and vascular function: A randomized, double-blind, placebo-controlled crossover study
Acronym
Effect of continuous ingestion of seabuckthorn juice on iron metabolism and vascular function
Scientific Title
Effect of continuous ingestion of seabuckthorn juice on iron metabolism and vascular function: A randomized, double-blind, placebo-controlled crossover study
Scientific Title:Acronym
Effect of continuous ingestion of seabuckthorn juice on iron metabolism and vascular function
Region
| Japan |
Condition
Condition
Healthy Adult
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effects of 4 weeks of continuous ingestion of seabuckthorn juice on iron metabolism after one bout of exercise in a randomized, double-blind, placebo-controlled crossover study
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Indicators of iron metabolism at the end of the ingestion period (iron, ferritin, total iron binding capacity, hepcidin, erythropherone, erythropoietin)
Key secondary outcomes
Blood pressure (brachial), heart rate, flow mediated dilation (brachial artery), blood glucose concentration
Hemoglobin, red blood cell count, white blood cell count, hematocrit
Indicators of oxidative stress (d-ROM, BAP)
Indicators of indirect muscle damage (myoglobin)
Indicators of inflammatory response (IL-6)
Base
Study type
Interventional
Study design
Basic design
Cross-over
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
4
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Continuous intake of 60ml of seabuckthorn juice for 4 weeks.
Performing an oral glucose tolerance test and an exercise test before and after juice intake period
Interventions/Control_2
Continuous intake of 60ml of placebo juice for 4 weeks.
Performing an oral glucose tolerance test and an exercise test before and after juice intake period
Interventions/Control_3
Continuous intake of 30ml of seabuckthorn juice for 4 weeks.
Performing an oral glucose tolerance test and an exercise test before and after juice intake period
Interventions/Control_4
Continuous intake of 30ml of placebo juice for 4 weeks.
Performing an oral glucose tolerance test and an exercise test before and after juice intake period
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
| 30 | years-old | >= |
Gender
Male
Key inclusion criteria
1.Healthy Japanese male aged 20 to 30 years.
2.Participants who agree to participate in this study with a written informed consent.
Key exclusion criteria
1.who have been diagnosed with a disease for which exercise is absolutely contraindicated
2.who have metabolic, respiratory, cardiovascular, or coagulation system diseases, or who are prohibited by a physician from high-intensity exercise
3.who have an orthopedic disease that interferes with running up to moderate intensity
4.who are taking medication or supplements on a daily basis
5.who are allergic to milk
6.who have other difficulties in measurements
Target sample size
24
Research contact person
Name of lead principal investigator
| 1st name | Kazushige |
| Middle name | |
| Last name | Goto |
Organization
Ritsumeikan University
Division name
Department of Sport and Health Science
Zip code
525-8577
Address
1-1-1, Noji-higashi, Kusatsu, Shiga, 525-8577, JAPAN
TEL
077-599-4127
kagoto@fc.ritsumei.ac.jp
Public contact
Name of contact person
| 1st name | Kazushige |
| Middle name | |
| Last name | Goto |
Organization
Ritsumeikan University
Division name
Department of Sport and Health Science
Zip code
525-8577
Address
1-1-1, Noji-higashi, Kusatsu, Shiga, 525-8577, JAPAN
TEL
077-599-4127
Homepage URL
kagoto@fc.ritsumei.ac.jp
Sponsor or person
Institute
Ritsumeikan University
Institute
Department
Personal name
Funding Source
Organization
Finess Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Review Committee for Medical and Health Research Involving Human Subjects
Address
1-1-1, Noji-higashi, Kusatsu, Shiga, 525-8577, JAPAN
Tel
077-599-4175
b-rinri@st.ritsumei.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 | 09 | 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
| 2023 | Year | 05 | Month | 08 | Day |
Date of IRB
| 2023 | Year | 05 | Month | 08 | Day |
Anticipated trial start date
| 2023 | Year | 05 | Month | 09 | Day |
Last follow-up date
| 2025 | 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
| 2023 | Year | 05 | Month | 09 | Day |
Last modified on
| 2025 | Year | 02 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058162
