UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054456 |
|---|---|
| Receipt number | R000062199 |
| Scientific Title | Intestinal Regulation and Physical Composition Evaluation Trial by Continued Consumption of Test Beverage - A Randomized, Placebo-Controlled, Double-Blind, Parallel-Group Comparison Study - |
| Date of disclosure of the study information | 2024/05/23 |
| Last modified on | 2024/11/28 11:14:51 |
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Basic information
Public title
Intestinal Regulation and Physical Composition Evaluation Trial by Continued Consumption of Test Beverage
Acronym
Intestinal Regulation and Physical Composition Evaluation Trial by Continued Consumption of Test Beverage
Scientific Title
Intestinal Regulation and Physical Composition Evaluation Trial by Continued Consumption of Test Beverage
- A Randomized, Placebo-Controlled, Double-Blind, Parallel-Group Comparison Study -
Scientific Title:Acronym
Intestinal Regulation and Physical Composition Evaluation Trial by Continued Consumption of Test Beverage
- A Randomized, Placebo-Controlled, Double-Blind, Parallel-Group Comparison Study -
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim is to assess the intestinal regulation and impact on the physical composition of a test beverage when continually consumed by healthy individuals between the ages of 20 and less than 65.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
-Number of Bowel Movements
-Days of Bowel Movement
-Amount of Bowel Movement
Key secondary outcomes
-Stool Condition
-Defecation Survey
-Evaluation of Intestinal Flora (16S rRNA Gene Analysis)
-Intra-abdominal Fat Area, Subcutaneous Fat Area, Total Fat Area by CT
-Waist Circumference, Hip Circumference, Waist-to-Hip Ratio
-BMI
-Body Fat Percentage
-Body Weight
Base
Study type
Interventional
Study design
Basic design
Parallel
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
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Participants intake test beverage of 280mL daily for eight weeks.
Interventions/Control_2
Participants intake placebo beverage of 280mL daily for eight 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.Age: 20 to less than 65 years old at time of informed consent
2.Sex: Japanese men and women
3.BMI of 22 to less than 30 kg/m^2
4.Constipation tendency (four bowel movements per week or fewer than four bowel movements per week)
5.Capable to enter digital diary via smartphone or PC.
6.Voluntarily agrees to participate after understanding the purpose and content of the research, and provides written consent.
Key exclusion criteria
1.Currently undergoing treatment for any disease, or taking medication or herbal remedies (as-needed medication allowed)
2.Undergoing diet or exercise therapy under medical supervision
3.Planning to undergo endoscopy or gastric barium testing during study period.
4.Has metal in the CT measurement area.
5.Has an implantable cardioverter-defibrillator such as a pacemaker.
6.Has been diagnosed with familial hyperlipidemia.
7.Has or had a drug addiction.
8.Has history of serious liver, kidney, heart, respiratory, endocrine, metabolic disease (such as diabetes).
9.Has undergone gastrointestinal surgery (except appendicitis).
10.Is lactose intolerant or has been diagnosed with lactose intolerance.
11.Has current or previous drug or food allergy.
12.Currently taking over-the-counter drugs, quasi-drugs, special health foods for health maintenance or recovery, foods for specified health uses, health foods, supplements, and can't stop intake during the research period.
13.Regularly consumes foods or supplements containing many lactic acid bacteria, Bifidobacterium, oligosaccharides, dietary fiber (four times a week or more as a guide).
14.Has irregular lifestyle (shift work, night work etc.)
15.Plans to travel abroad during study period.
16.Heavy smoker (21 or more cigarettes per day).
17.Heavy drinker (intake of pure alcohol 40g/day or more).
18.Currently pregnant or nursing or planning to become pregnant during the study period.
19.Has participated in other clinical studies in the month before consent acquisition or currently participating, or plans to participate during the research period.
20.Experienced major changes in lifestyle habits (eating, sleeping, exercise habits, etc.) or social environment (moving, job loss, divorce, death of a spouse or relative, etc.) within a month before consent acquisition.
21.Deemed unsuitable to participate in this study by the Principal Investigator.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Hirosuke |
| Middle name | |
| Last name | Sugahara |
Organization
ASAHI QUALITY & INNOVATIONS, LTD.
Division name
Department of Brewing science III
Zip code
302-0106
Address
1-21, MIDORI 1-CHOME, MORIYA-SHI, IBARAKI
TEL
080-7789-1246
hirosuke.sugahara@asahi-qi.co.jp
Public contact
Name of contact person
| 1st name | Hirokuni |
| Middle name | |
| Last name | Kayama |
Organization
IMEQRD Co., Ltd.
Division name
Planning and Sales Department
Zip code
104-0061
Address
6-2-1 Ginza Chuo-ku Tokyo Japan
TEL
03-6704-5968
Homepage URL
clinical-trial@imeqrd.co.jp
Sponsor or person
Institute
IMEQRD Co. Ltd.
Institute
Department
Personal name
Funding Source
Organization
ASAHI QUALITY & INNOVATIONS, 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
Suda Clinic institutional review board
Address
2-8-14,Takadanobaba,Shinjyuku,Tokyo
Tel
03-6704-5968
jimukyoku@imeqrd.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
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 05 | 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
| 2024 | Year | 05 | Month | 14 | Day |
Date of IRB
| 2024 | Year | 05 | Month | 21 | Day |
Anticipated trial start date
| 2024 | Year | 08 | Month | 17 | Day |
Last follow-up date
| 2024 | Year | 10 | Month | 13 | 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 | 05 | Month | 22 | Day |
Last modified on
| 2024 | Year | 11 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062199
