UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040659 |
|---|---|
| Receipt number | R000046410 |
| Scientific Title | A study for evaluating the effects of oral intake of dietary fiber complex on body fat and intestinal flora in human. |
| Date of disclosure of the study information | 2020/06/05 |
| Last modified on | 2024/05/16 15:32:29 |
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Basic information
Public title
A study for evaluating the effects of oral intake of dietary fiber complex on body fat and intestinal flora in human.
Acronym
A study for evaluating the effects of oral intake of dietary fiber complex on body fat and intestinal flora in human.
Scientific Title
A study for evaluating the effects of oral intake of dietary fiber complex on body fat and intestinal flora in human.
Scientific Title:Acronym
A study for evaluating the effects of oral intake of dietary fiber complex on body fat and intestinal flora in human.
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To confirm the effect of continuous intake of test food for 12 weeks on body fat and intestinal environment in healthy male and female from 20 to 64 years old.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Visceral fat area
Key secondary outcomes
Physical examination(Weight, Body mass index, Waist circumference), Subcutaneous fat area, Total fat area, TG, TC, HDL-C, LDL-C,
Intestinal flora test, Defecation questionnaire, Questionnaire
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
Take 5 capsles of test food with water 3 times a day, before breakfast, lunch, and dinner.
Interventions/Control_2
Take 5 capsles of placebo with water 3 times a day, before breakfast, lunch, and dinner.
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
1.20 to 64 years old (at the time of submission of an informed consent document).
2.Japanese males and females.
3.BMI of 23.0 kg/m2 to < 30.0 kg/m2
4.Those who tend to feel constipated.
5.Smartphone or PC users (who can input their own data into the electronic diary).
6.Those who can provide their written informed consent.
Key exclusion criteria
1.Those who are currently receiving any types of medicines and/or Chinese medical treatments (except for the medicines that are taken as needed).
2.Those who have or had a severe disease of the liver, heart, kidneys, gastrointestinal tract, respiratory system, endocrine, and metabolism
3.Those who are receiving nutrition therapy or physical therapy under a doctor's supervision.
4.Those who received gastrointestinal surgery (except appendectomy).
5.Those who have been routinely taking medicines, foods with health claim (foods for specified health use, in particular), health foods, or supplements that may affect the body fat and/or bowel movement.
6.Those who cannot abstain from taking health foods during the study period.
7.Those who have a current or previous history of drug and/or food allergies.
8.Smokers.
9.Heavy drinkers.
10.Those who have metals implanted in the body due to surgery etc.
11.Those who have a cardiac pacemaker or an implantable medical device placed in the body.
12.Those who have claustrophobia.
13.Those who work night shifts.
14.Those who are currently undergoing treatment for drug dependence or drug abuse or those who have a past medical history of either of them.
15.Those who are currently pregnant or breastfeeding or those who want to become pregnant during the study period.
16.Those who are currently participating in another clinical trial or those who took a test product and completed another clinical trial in a month.
17.Those who were determined by the principal investigator and the sub investigator to be unsuitable for participation in this clinical trial.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Hisayo |
| Middle name | |
| Last name | Ikeda |
Organization
NexgenNutrient Japan Co. Ltd.,
Division name
Advanced Health Science Research Center
Zip code
537-0022
Address
2-1-13,Nakamoto,Higashinari-ku,Osaka-shi,Osaka,Japan
TEL
06-6981-6100
h.ikeda@nutriomix.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
NexgenNutrient Japan Co. Ltd.,
Organization
Division
Category of Funding Organization
Other
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
| 2020 | Year | 06 | Month | 05 | 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 | 04 | Month | 22 | Day |
Date of IRB
| 2020 | Year | 04 | Month | 24 | Day |
Anticipated trial start date
| 2020 | Year | 08 | Month | 08 | Day |
Last follow-up date
| 2020 | Year | 11 | Month | 01 | 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 | 06 | Month | 05 | Day |
Last modified on
| 2024 | Year | 05 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046410
