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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000033707
Receipt No. R000038431
Official scientific title of the study Effects of consumption of the test food in healthy Japanese normal to overweight subjects: a randomized, double-blind, placebo-controlled, parallel-group trial
Date of disclosure of the study information 2018/08/10
Last modified on 2018/11/09

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Basic information
Official scientific title of the study Effects of consumption of the test food in healthy Japanese normal to overweight subjects: a randomized, double-blind, placebo-controlled, parallel-group trial
Title of the study (Brief title) Effects of consumption of the test food in healthy Japanese normal to overweight subjects
Region
Japan

Condition
Condition Japanese subjects between 23 kg/m2 or more and less than 30 kg/m2 in body mass index (BMI)
Classification by specialty
Not applicable Adult Child
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To verify the visceral fat reducing effect with the consumption of the test food for 12 weeks in Japanese adult subjects between 23 kg/m2 or more and less than 30 kg/m2 in BMI
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes The visceral fat area in a cross section of the umbilical region

* Assess the fat area by X-ray CT
* Calculate the amount of change between screening (before consumption) and 12 weeks after consumption
Key secondary outcomes 1. Total fat area
2. Subcutaneous fat area
3. Visceral fat area
4. Serum adiponectin level
5. Serum total cholesterol level
6. Serum HDL-cholesterol level
7. Serum LDL-cholesterol level
8. Serum neutral fat (TG: triglyceride) level
9. Serum glucose level
10. Height
11. Body weight
12. Body mass index
13. Body fat percentage
14. Body temperature
15. Abdominal circumference
16. Muscle mass
17. Basal metabolic rate
18. Subjective symptoms (A questionnaire)

*1-9, 11-18 Assess these tests at screening (before consumption) and at 12 weeks after consumption
*10 Measure the height only at screening (before consumption)
*1-2 Assess these by X-ray CT. Measure the fat area of umbilicus cross section and calculate the amount of change between screening (before consumption) and 12 weeks after consumption.
*3 Assess the measured value of the fat area in a cross section of the umbilical region by X-ray CT.
*4-9, 11-17 Measure the items and calculate the amount of change between screening (before consumption) and 12 weeks after consumption.
*18 Assess symptoms by the Likert scale. Each item is assessed with a six-point grading scale from 1 (strongly disagree) to 6 (strongly agree). The smaller number indicates better condition.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 Duration: 12 weeks
Test material: Capsules containing malted rice
Dose: Take 2 capsules per day
Administration: Take 2 capsules with water or warm water after breakfast

* If you forget to take capsules, take these as soon as you remember within the day.
Interventions/Control_2 Duration: 12 weeks
Test material: Placebo capsule
Dose: Take 2 capsules per day
Administration: Take 2 capsules with water or warm water after breakfast

* If you forget to take capsules, take these as soon as you remember within the day.
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

Not applicable
Gender Male and Female
Key inclusion criteria 1. Japanese adult subjects between 23 kg/m2 or more and less than 30 kg/m2 in BMI

2. Subjects who are judged as eligible to participate in the study by the physician

3. Within the subjects who met the 1st and 2nd inclusion criteria, subjects whose visceral fat area of umbilicus cross section are relatively large
Key exclusion criteria 1. Subjects who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, myocardial infarction, endometriosis, uterine myoma, and mental disorders

2. Currently undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disease, kidney disease, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases

3. Subjects who use or take "Foods for Specified Health Uses", "Foods with Functional Claims", or other functional food/beverage in daily

4. Subjects who have exercise habits more than 3 times per week

5. Subjects who are currently taking medications (including herbal medicines) and supplements

6. Subjects who are allergic to medicines and/or the test food related products

7. Subjects who are pregnant, lactation, or planning to become pregnant

8. Subjects who have been enrolled in other clinical trials within the last three months before the agreement to participate in this trial

9. Subjects who are judged as ineligible to participate in the study by the physician
Target sample size 20

Research contact person
Name of lead principal investigator Kazuo YAMAMOTO
Organization ORTHOMEDICO Inc.
Division name CEO
Address 2F Sumitomo Fudosan Korakuen Bldg., 1-4-1, Koishikawa, Bunkyo-ku, Tokyo, Japan.
TEL 03-3818-0610
Email kazu@orthomedico.jp

Public contact
Name of contact person Naoko SUZUKI
Organization ORTHOMEDICO Inc.
Division name R&D Department
Address 2F Sumitomo Fudosan Korakuen Bldg., 1-4-1, Koishikawa, Bunkyo-ku, Tokyo, Japan.
TEL 03-3818-0610
Homepage URL
Email nao@orthomedico.jp

Sponsor
Institute ORTHOMEDICO Inc.
Institute
Department

Funding Source
Organization HEALTH UP INC.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor Medical Corporation Seishinkai, Takara Clinic
Name of secondary funder(s)

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 医療法人社団盛心会 タカラクリニック (東京都)
Medical Corporation Seishinkai, Takara Clinic (Tokyo, Japan)

Other administrative information
Date of disclosure of the study information
2018 Year 08 Month 10 Day

Progress
Recruitment status No longer recruiting
Date of protocol fixation
2018 Year 08 Month 06 Day
Anticipated trial start date
2018 Year 08 Month 20 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information

Management information
Registered date
2018 Year 08 Month 10 Day
Last modified on
2018 Year 11 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038431

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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