UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055660 |
|---|---|
| Receipt number | R000063609 |
| Scientific Title | Study to verify the efficacy of the intestinal regulating effect of the intake of seabuckthorn Juice. |
| Date of disclosure of the study information | 2024/10/01 |
| Last modified on | 2025/03/30 12:28:44 |
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Basic information
Public title
Study to verify the efficacy of the intestinal regulating effect of the intake of seabuckthorn Juice.
Acronym
Study to verify the efficacy of the intestinal regulating effect of the intake of seabuckthorn Juice.
Scientific Title
Study to verify the efficacy of the intestinal regulating effect of the intake of seabuckthorn Juice.
Scientific Title:Acronym
Study to verify the efficacy of the intestinal regulating effect of the intake of seabuckthorn Juice.
Region
| Japan |
Condition
Condition
Healthy Adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effects of seabuckthorn Juice consumption on bowel movements and intestinal environment.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Number of days of defecation, frequency of defecation
Key secondary outcomes
Defecation volume, distribution of intestinal flora (bacterial flora), shape of defecation, stool color, odor, sensation after defecation
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Intake of seabuckthorn juice
Interventions/Control_2
Intake of placebo juice
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
| 60 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1) Men and women between the ages of 20 and 64
(2) Those who tend to be constipated, with a normal frequency of bowel movements of about 3 to 5 times per week.
(3) Those who have a regular diet (3 meals a day (breakfast, lunch, and dinner))
(4) Have given written consent to participate in the study voluntarily.
Key exclusion criteria
(1) Those with a confirmed diagnosis of constipation and chronic constipation or those who meet the criteria of the Guidelines for the Treatment of Chronic Constipation 2017.
(2) Persons who consume foods or health foods listed as containing seabuckthorn Juice, the food under study.
(3) Persons who regularly use medicines, health foods, foods for specified health uses, foods with functional claims (non-digestible dextrin, chitosan, oligosaccharides, etc.) that may affect bowel movements
(4) Persons who are determined to be lactose intolerant, including self-reported lactose intolerance
(5) Persons who habitually consume dietary supplements or dietary supplements related to immune function
(6) Patients who are visiting the hospital or using drugs or over-the-counter laxatives for bowel movement-related diseases at the time of participation in the study
(7) Have a disease or pre-existing condition that is considered to significantly affect bowel movements, such as irritable bowel disease or ulcerative colitis.
(8) Those who work night shifts or day/night shifts
(9) Patients who are undergoing treatment at a medical institution for treatment or prevention of disease, or whose condition is judged to be in need of treatment at the time of obtaining consent.
(10) Those with a history of serious diseases of the glucose metabolism, lipid metabolism, liver function, renal function, heart, circulatory system, respiratory system, endocrine system, immune system, or nervous system, or psychiatric diseases
(11) Those with a history of alcohol and drug dependence
(12) Persons who are at risk of developing allergies to foods
(13) Pregnant or lactating at the time consent is obtained, or wishes to become pregnant during the study period
(14)Persons who are deemed by the investigator (or the study investigator) to be unsuitable to participate in the study.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Ryuji |
| Middle name | |
| Last name | Takeda |
Organization
Kansai University of Welfare Sciences
Division name
Department of Nutritional Sciences for Welll-being, Faculty of Health Science for Welfare
Zip code
582-0026
Address
Asahigaoka 3-11-1, Kashiwara, Osaka
TEL
0729780088
rtakeda@tamateyama.ac.jp
Public contact
Name of contact person
| 1st name | Shigenori |
| Middle name | |
| Last name | Nibun |
Organization
EAS inc.
Division name
Clinical Trial Session
Zip code
239-0028
Address
Susaki-Cho1-10-2F, Kanazawa-ku, Yokohama city, Kanagawa
TEL
045-374-3392
Homepage URL
info@eas-ct.jp
Sponsor or person
Institute
Finess Co, Ltd.
Institute
Department
Personal name
Funding Source
Organization
Finess 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
KOBUNA ORTHOPEDIC SURGERY
Address
311-2, Gokan-machi, Maebashi, Gunma
Tel
027-261-7600
info@kobunaseikei.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
| 2024 | Year | 10 | Month | 01 | 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
| 2024 | Year | 08 | Month | 20 | Day |
Date of IRB
| 2024 | Year | 08 | Month | 23 | Day |
Anticipated trial start date
| 2024 | Year | 10 | Month | 01 | 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
| 2024 | Year | 09 | Month | 28 | Day |
Last modified on
| 2025 | Year | 03 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063609
