UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000019451
Receipt No. R000022407
Scientific Title Double-Blind, Placebo-Controlled, Parallel Group Comparison Study on the Effect of Saccharina Sculpera on Immune Activation
Date of disclosure of the study information 2015/10/23
Last modified on 2016/11/24

* 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 Double-Blind, Placebo-Controlled, Parallel Group Comparison Study on the Effect of Saccharina Sculpera on Immune Activation
Acronym Effect of Daily Ingestion of Saccharina sculpera on Immune Activation
Scientific Title Double-Blind, Placebo-Controlled, Parallel Group Comparison Study on the Effect of Saccharina Sculpera on Immune Activation
Scientific Title:Acronym Effect of Daily Ingestion of Saccharina sculpera on Immune Activation
Region
Japan

Condition
Condition Healthy adults
Classification by specialty
Not applicable Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To prove the clinical benefits of daily ingestion of Saccharina sculpera on immune activation for 8 weeks.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Others
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Natural Killer cell activity at 4 and 8 weeks after ingestion of test meals.
Key secondary outcomes leukocyte differential count, IgM,IgA,IL-12,IL-2,IFN-gamma, flow cytometric lymphocyte subset analysis, VAS scores for fatigue, etc. and defecation frequency

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 Ingestion of 4 capsules containing powdered Saccharina sculpera 0.8g daily for 8 weeks.
Interventions/Control_2 Ingestion of 4 capsules containing dextrin daily for 8 weeks.
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
35 years-old <=
Age-upper limit
65 years-old >
Gender Male and Female
Key inclusion criteria 1.Subjects who have relatively low NK cell activity.
2.Subjects who agree to participate in the current clinical trial with a written informed consent.
Key exclusion criteria 1.Subjects who are under treatment or medication for chronic inflammatory diseases, autoimmune diseases, allergies or thyroid disorders.
2.Subjects with serious cerebrovascular, cardiac, hepatic, renal, gastrointestinal, endocrine or metabolic disorders, or affected with infectious diseases which is required to report to the authorities.
3.Subjects who have a major surgical history such as gastrectomy, gastrorrhaphy, enterectomy or other serious gastrointestinal surgeries.
4.Pre- or post-menopausal women having complaints of obvious physical changes.
5.Subjects with unusually high and/or low blood pressure, and/or with abnormal hematological data.
6.Subjects with serious anemia.
7.Subjects with a history of allergy to medicine or food (especially seaweeds and gelatin).
8.Subjects who regularly take medicines, functional food or supplements (mushrooms, seaweed, nucleic acids, yeast, lactobacillus, etc.) which would affect the immune function,
9.Heavy smokers, alcohol addicts or subjects with irregular lifestyle
10.Subjects who donate either 400ml whole blood within 12 weeks or 200ml whole blood within 4 weeks or blood component(s) within 2 weeks prior to this study
11.Subjects who are pregnant or expected to be pregnant, or lactating during the study.
12.Subjects who participate in other clinical trials within the last one month prior to this study.
13.Any other medical reasons judged by the principal investigator.
Target sample size 48

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Prof. Jun NISHIHIRA, M.D., Ph.D.
Organization Hokkaido Information University
Division name Department of Medical Management and Informatics
Zip code
Address 59-2, Nishi-nopporo, Ebetsu, Hokkaido, 069-8585, Japan
TEL 011-385-4411
Email nishihira@do-johodai.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Dir. Prof. Jun NISHIHIRA, M.D., Ph.D.
Organization Hokkaido Information University
Division name Health Information Science Center
Zip code
Address 59-2, Nishi-nopporo, Ebetsu, Hokkaido, 069-8585, Japan
TEL 011-385-4430
Homepage URL
Email nishihira@do-johodai.ac.jp

Sponsor
Institute Hokkaido Information University
Institute
Department

Funding Source
Organization Northern Advancement Center for Science & Technology
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 北海道情報大学 保健センター(北海道)

Other administrative information
Date of disclosure of the study information
2015 Year 10 Month 23 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
2015 Year 09 Month 30 Day
Date of IRB
Anticipated trial start date
2015 Year 10 Month 30 Day
Last follow-up date
2016 Year 01 Month 20 Day
Date of closure to data entry
2016 Year 03 Month 04 Day
Date trial data considered complete
2016 Year 03 Month 11 Day
Date analysis concluded
2016 Year 11 Month 17 Day

Other
Other related information

Management information
Registered date
2015 Year 10 Month 22 Day
Last modified on
2016 Year 11 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022407

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.