UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039266 |
|---|---|
| Receipt number | R000044781 |
| Scientific Title | A study on the effects of Jerusalem artichoke inulin intake on reducing visceral fat: A double-blind parallel group comparative study. |
| Date of disclosure of the study information | 2020/01/27 |
| Last modified on | 2020/07/21 14:48:23 |
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Basic information
Public title
A study on the effects of Jerusalem artichoke inulin intake on reducing visceral fat: A double-blind parallel group comparative study.
Acronym
A study on the effects of Jerusalem artichoke inulin intake on reducing visceral fat: A double-blind parallel group comparative study.
Scientific Title
A study on the effects of Jerusalem artichoke inulin intake on reducing visceral fat: A double-blind parallel group comparative study.
Scientific Title:Acronym
A study on the effects of Jerusalem artichoke inulin intake on reducing visceral fat: A double-blind parallel group comparative 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 examine whether a 12-week continuous intake of Jerusalem artichoke inulin-containing product (test product) affects visceral fat in mildly overweight men and women aged 20-64 who are slightly constipated.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Visceral fat area (V), Subcutaneous fat area (S), Total fat area, Weight, Body mass index (BMI), and Waist circumference.
Key secondary outcomes
Stool test (a simple analysis to see changes in bacterial population using T-RFLP), Defecation questionnaire, TG, T-Cho, HDL-C, LDL-C, HbA1c, Blood glucose levels, and Serum uric acid levels.
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
Dissolve Jerusalem artichoke inulin-containing product (test product) in a beverage or others. Drink it once daily.
Interventions/Control_2
Dissolve placebo in a beverage or others. Drink it once daily.
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. BMI of 23.0 kg/m2 to < 30.0 kg/m2
2. Those who are slightly constipated and have 3 to 5 stools per week.
3. Those whose constipation symptoms have lasted for more than 3 months.
4. Those who do not change or do not intend to change daily life habits during the study period.
5. Those who can provide their written informed consent.
Key exclusion criteria
1. Those who are currently receiving some types of drug treatment, for example, treatment affecting obesity, hyperlipidemia, lipid metabolism, and harmonious intestinal action (except for the drugs that are taken as needed in those with complications or living with chronic diseases).
2. Those who are receiving nutrition therapy or physical therapy under a doctor's supervision.
3. Those who cannot stop taking health foods or supplements during the study period.
4. Those who cannot stop drinking alcohol the day before a test.
5. Those who have a current or a past medical history of severe diseases.
6. Those who have a current or a past medical history of drug or food allergy.
7. Those who have a current or a past medical history of drug or alcohol dependence.
8. Those who have metals implanted in the body due to surgery etc.
9. Those who have a cardiac pacemaker or an implantable medical device placed in the body.
10. Those who have claustrophobia.
11. Smokers.
12. Those who work night shifts.
13. Those who are currently pregnant or breastfeeding or those who want to become pregnant during the study period.
14. Those who are currently participating in another clinical trial or those who took a test product and completed another clinical trial in a month.
15. Those who were determined by the principal investigator to be an unsuitable subject for this study.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Naoki |
| Middle name | |
| Last name | Hiramatsu |
Organization
Melodian CO.,LTD.
Division name
Research & development division
Zip code
581-0869
Address
1-33,Asahigaoka,Yao-Shi,Osaka
TEL
072-924-3215
naohiramatsu@melodian.co.jp
Public contact
Name of contact person
| 1st name | Naomi |
| Middle name | |
| Last name | Yuzawa |
Organization
imeQ RD inc.
Division name
Sales department
Zip code
169-0051
Address
2-14-6, Nishi-Waseda, Shinjyuku, Tokyo
TEL
03-6205-6222
Homepage URL
n-yuzawa@imeqrd.co.jp
Sponsor or person
Institute
imeQ RD inc.
Institute
Department
Personal name
Funding Source
Organization
Melodian CO.,LTD.
Organization
Division
Category of Funding Organization
Self funding
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
03-6205-6222
suda-clinic_irb@imeq.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 | 01 | Month | 27 | 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
| 2019 | Year | 12 | Month | 23 | Day |
Date of IRB
| 2019 | Year | 12 | Month | 25 | Day |
Anticipated trial start date
| 2020 | Year | 02 | Month | 25 | Day |
Last follow-up date
| 2020 | Year | 05 | Month | 19 | 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 | 01 | Month | 27 | Day |
Last modified on
| 2020 | Year | 07 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044781
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