UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042753 |
|---|---|
| Receipt number | R000048796 |
| Scientific Title | Effect of Daily Ingestion of Partially Hydrolyzed Guar Gum (PHGG) on Immune Function: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study |
| Date of disclosure of the study information | 2020/12/15 |
| Last modified on | 2021/10/25 09:55:54 |
* 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 Daily Ingestion of Partially Hydrolyzed Guar Gum (PHGG) on Immune Function: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study
Acronym
Beneficial Effects of Partially Hydrolyzed Guar Gum (PHGG) on Immune Function
Scientific Title
Effect of Daily Ingestion of Partially Hydrolyzed Guar Gum (PHGG) on Immune Function: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study
Scientific Title:Acronym
Beneficial Effects of Partially Hydrolyzed Guar Gum (PHGG) on Immune Function
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate clinical benefits associated with immune function on 12 weeks daily ingestion of partially hydrolyzed guar gum (PHGG) in a randomized, double-blind, placebo-controlled, parallel group study.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
Diary about cold-like symptoms at 6 and 12 weeks after beginning the intake of test food.
Key secondary outcomes
Salivary secretory IgA, number of NK cells, CD4/CD8 ratio, number of Treg cells, serum IgG, five fraction of leukocyte, serum cytokines (IFN-gamma, IL-10), organic acids in feces.
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
Blocking
YES
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Daily ingestion 7.2 g of Partially Hydrolyzed Guar Gum (PHGG) for 12 weeks.
Interventions/Control_2
Daily ingestion 7.2 g of dextrin for 12 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
| 20 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Subjects who fully understand significance, content and purpose of this study and who agree to participate in this study with a written informed consent.
2. Subjects with relatively high score for 18 items related to psychological stress on The Brief Job Stress Questionnaire.
Key exclusion criteria
1. Subjects who are under treatment or medication for autoimmune diseases, chronic inflammatory diseases or allergies.
2. Subjects who plan to receive influenza vaccination from the screening test date to the end of intake.
3. Subjects with serious cerebrovascular, cardiac, hepatic, renal, gastrointestinal or affected with infectious diseases which is required to report to the authorities.
4. Subjects who have a major surgical history such as gastrectomy, gastrorrhaphy, enterectomy or other serious gastrointestinal surgeries.
5. Subjects with unusually high and/or low blood pressure, abnormal physical data and/or abnormal hematological data.
6. Subjects with severe anemia.
7. Pre- or post-menopausal women complaining of obvious physical changes.
8. Subjects who are at risk of having allergic reactions to drugs, foods (especially soybeans or peanuts) and/or birch pollen.
9. Subjects who regularly take medicines (Antibiotics, immunosuppressants, anti-inflammatory drugs, antirheumatic drugs, antihistamines, antiallergic drugs, lactic acid bacteria preparations), functional food and/or supplements (mushrooms, seaweed, nucleic acids, yeast, lactobacillus, etc.) which would affect the immune function.
10. Heavy smokers, alcohol addicts or subjects with irregular lifestyle.
11. Subjects who donated either 400 ml whole blood within 16 weeks (women), 12 weeks (men), 200 ml whole blood within 4 weeks, or blood components within 2 weeks, prior to the current study.
12. Pregnant or lactating women or women who expect to be pregnant during this study.
13. Subjects who currently participate in other clinical trials, or participated within the last 4 weeks prior to the current study.
14. Subjects determined to be ineligible by the principal investigator.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Jun |
| Middle name | |
| Last name | NISHIHIRA |
Organization
Hokkaido Information University
Division name
Department of Medical Management and Informatics
Zip code
069-8585
Address
59-2, Nishi-nopporo, Ebetsu, Hokkaido, Japan
TEL
011-385-4411
nishihira@do-johodai.ac.jp
Public contact
Name of contact person
| 1st name | Naoyuki |
| Middle name | |
| Last name | HONMA |
Organization
Hokkaido Information University
Division name
Health Information Science Center
Zip code
069-8585
Address
59-2, Nishi-nopporo, Ebetsu, Hokkaido, Japan
TEL
011-385-4430
Homepage URL
hisc-acad.res@s.do-johodai.ac.jp
Sponsor or person
Institute
Hokkaido Information University
Institute
Department
Personal name
Funding Source
Organization
Nestle Japan Ltd.
Taiyo Kagaku 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
The ethics committee of Hokkaido Information University
Address
59-2, Nishi-nopporo, Ebetsu, Hokkaido, 069-8585, Japan
Tel
011-385-4411
soumu@do-johodai.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
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
| 2020 | Year | 12 | Month | 15 | 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
| 2020 | Year | 11 | Month | 25 | Day |
Date of IRB
| 2020 | Year | 11 | Month | 25 | Day |
Anticipated trial start date
| 2021 | Year | 01 | Month | 07 | Day |
Last follow-up date
| 2021 | Year | 04 | Month | 27 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 12 | Month | 14 | Day |
Last modified on
| 2021 | Year | 10 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048796
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
