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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000039266
Receipt No. 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

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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
Email 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
Email n-yuzawa@imeqrd.co.jp

Sponsor
Institute imeQ RD inc.
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044781

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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