UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056466 |
|---|---|
| Receipt number | R000064524 |
| Scientific Title | Study of effects on physical condition by the intake of gluten-free foods |
| Date of disclosure of the study information | 2024/12/16 |
| Last modified on | 2025/12/17 14:58:08 |
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Basic information
Public title
Study of effects on physical condition by the intake of gluten-free foods
Acronym
Study of effects on physical condition by the intake of gluten-free foods
Scientific Title
Study of effects on physical condition by the intake of gluten-free foods
Scientific Title:Acronym
Study of effects on physical condition by the intake of gluten-free foods
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effects of gluten-free foods on abdominal symptom and blood markers after 4 weeks of ingestion.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
abdominal symptom
Key secondary outcomes
blood examination, feces examination, QOL questionnaire
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Intake of gluten-free foods for 4 consecutive weeks
Interventions/Control_2
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
| 18 | years-old | <= |
Age-upper limit
| 64 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) Males and females from 18 to 64 years of age
(2) Subjects with BMI level of 18.5 or more and less than 25.0 kg/m2
(3) Subjects who intake wheat processed food as staple food 14 or more per week and correspond to (A) or (B)
(A) Subjects who do not feel any particular change in their physical condition
(B) Subjects who are aware of abdominal symptom
Conditions corresponding to (B), either or both of following
(i) abdominal symptom, 1 or more of the following: postprandial fullness, early satiation, epigastric pain, and epigastric burning, which are unexplained after a routine clinical evaluation; and includes 2 subcategories: postprandial distress syndrome that is characterized by meal-induced dyspeptic symptoms and epigastric pain syndrome that does not occur exclusively postprandially; the 2 subgroups can overlap
(ii) abdominal symptom, Recurrent abdominal pain, on average, at least 1 day per week in the last 3 months, associated with 2 or more of the following criteria: related to defecation, associated with a change in frequency of stool, associated with a change in form (appearance) of stool: a criteria fulfilled for the last 3 months with symptom onset at least 6 months before diagnosis
(4) Subjects who can limit their intake of processed wheat foods during the intervention period
(5) Subjects who fully understand the purpose and content of the study and voluntarily agree to participate in the study
Key exclusion criteria
(1) Subjects who has been diagnosed digestive system disease
(2) Subjects who have allergies related to a food
(3) Subjects who may develop allergies in relation to the study
(4) Subjects who have had abnormalities in clinical laboratory values or cardiopulmonary function, and are judged to have a problem participating in the study
(5) Subjects who have a disease that requires constant medication (whether external or internal), those who have a disease under treatment (except for dry eye and dental caries treatment), those who have a history of serious disease that required medication, and those who are scheduled for surgery
(6) Subjects whose physical measurements before the start of intake were significantly out of the reference range
(7) Subjects who work in shifts, work late at night, and have an irregular daily rhythm
(8) Subjects who have participated in other clinical trials within one month prior to obtaining consent to participate in this study
(9) Subjects who cannot intake gluten-free foods during the intervention due to the vacation, business trip or the event
(10) Subjects who plan to change daily habits during the study
(11) Subjects who eat a large amount of food at a time compared to the average amount of meals
(12) Subjects who have difficulty in keeping a diary.
(13) Subjects who plan to become pregnant or breastfeed during the study
(14) Subjects who are judged to be inappropriate as study subjects based on their answers to the lifestyle questionnaire
(15) Subjects who are judged as unsuitable for the study by the investigator for other reason
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Jyoto |
| Middle name | |
| Last name | Yoshimoto |
Organization
Mizkan Holdings Co.,Ltd.
Division name
Central Research Institute
Zip code
475-8585
Address
2-6 Nakamuracho, Handa, Aichi
TEL
080-1576-3917
yoshimoto_jyoutou@mizkan.co.jp
Public contact
Name of contact person
| 1st name | Kaori |
| Middle name | |
| Last name | Yoshimoto |
Organization
EP Mediate Co., Ltd.
Division name
Development Department
Zip code
162-0821
Address
Kagurazaka AK Bldg., 1-8 Tsukudocho, Shinjuku-ku, Tokyo
TEL
080-1193-3234
Homepage URL
yoshimura.kaori265@eps.co.jp
Sponsor or person
Institute
EP Mediate Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Mizkan Holdings 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
Medical Station Clinic Research Ethics Committee
Address
3-12-8, Takaban, Meguro-ku, Tokyo
Tel
03-6452-2712
nakajima.megumi888@eps.co.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
メディカルステーションクリニック
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 12 | Month | 16 | 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
30
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 | 12 | Month | 12 | Day |
Date of IRB
| 2024 | Year | 12 | Month | 12 | Day |
Anticipated trial start date
| 2024 | Year | 12 | Month | 16 | Day |
Last follow-up date
| 2025 | Year | 02 | Month | 28 | 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 | 12 | Month | 16 | Day |
Last modified on
| 2025 | Year | 12 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064524
