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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000040659
Receipt No. 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 2021/02/17

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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
Email 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 Sales department
Zip code 104-0061
Address 6-2-1 Ginza Chuo-ku Tokyo Japan
TEL 03-6704-5968
Homepage URL
Email h-kayama@imeqrd.co.jp

Sponsor
Institute IMEQRD Co., Ltd
Institute
Department

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
Email n-yuzawa@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
2021 Year 02 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046410

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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