UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036909 |
|---|---|
| Receipt number | R000042062 |
| Scientific Title | A verification study of slimming effect with ingestion of the test food: a randomized, double-blind, placebo-controlled, parallel-group trial |
| Date of disclosure of the study information | 2019/05/31 |
| Last modified on | 2020/03/18 18:42:32 |
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Basic information
Public title
A verification study of slimming effect with ingestion of the test food
Acronym
A verification study of slimming effect with ingestion of the test food
Scientific Title
A verification study of slimming effect with ingestion of the test food: a randomized, double-blind, placebo-controlled, parallel-group trial
Scientific Title:Acronym
A verification study of slimming effect with ingestion of the test food
Region
| Japan |
Condition
Condition
Healthy Japanese subjects
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the effects of 8-week-consumption of the test food on abdominal circumference.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Abdominal circumference
*Assess the measured value at screening (before consumption) and at 4 and 8 weeks after consumption or calculate the amount of change.
Key secondary outcomes
1. Body weight
2. Body fat percentage
3. Muscle mass
4. Lean body mass
5. Upper arm circumference diameter
6. Thigh circumference diameter
7. Hip circumference diameter
8. Body mass index
9. Waist-to-hip ratio
10. Subjective symptoms (The Likert scale method)
*1-9 Assess the measured value at screening (before consumption) and at 4 and 8 weeks after consumption or calculate the amount of change.
*10 Assess the measured value at screening (before consumption) and at 4 and 8 weeks after consumption.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
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: 8 weeks
Test food: Test food A
Administration: Take 4 capsules, once per day at any time during the day.
*Daily dose must be taken within the day.
Interventions/Control_2
Duration: 8 weeks
Test food: Placebo
Administration: Take 4 capsules, once per day at any time during the day.
* Daily dose must be taken 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. Healthy adults
2. Japanese subjects between >=23 kg/m2 and <30 kg/m2 in body mass index (BMI)
3. Subjects who are judged as ineligible to participate in the study by the physician
4. Subjects who have relatively large abdominal circumference at screening
5. Subjects who are between >=23 kg/m2 and <25 kg/m2 in BMI or between >=25 kg/m2 and <30 kg/m2 in BMI with <85 cm for men and <90cm for women in the abdominal circumference at screening
Key exclusion criteria
1. Subjects who are undergoing medical treatment or have a medical history of malignant tumor, heart failure or myocardial infarction
2. Subjects who have a pacemaker or an implantable cardioverter defibrillator (ICD)
3. Currently undergoing treatment for any of the following chronic disease: cardiac arrhythmia, liver disorder, kidney disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, obesity or any other chronic diseases
4. Subjects who use or take "Foods for Specified Health Uses", "Foods with Functional Claims", or other functional food/beverage in daily
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 allergic to citrus fruits.
8. Subjects who are pregnant, lactation, or planning to become pregnant
9. Subjects who have been enrolled in other clinical trials within the last three months before the agreement to participate in this trial or plan to participate another trial during this trial
10. Subjects who are judged as ineligible to participate in the study by the physician
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Kazuo |
| Middle name | |
| Last name | YAMAMOTO |
Organization
ORTHOMEDICO Inc.
Division name
CEO
Zip code
112-0002
Address
2F Sumitomo Fudosan Korakuen Bldg., 1-4-1, Koishikawa, Bunkyo-ku, Tokyo, Japan.
TEL
03-3818-0610
kazu@orthomedico.jp
Public contact
Name of contact person
| 1st name | Naoko |
| Middle name | |
| Last name | SUZUKI |
Organization
ORTHOMEDICO Inc.
Division name
R&D Department
Zip code
112-0002
Address
2F Sumitomo Fudosan Korakuen Bldg., 1-4-1, Koishikawa, Bunkyo-ku, Tokyo, Japan.
TEL
03-3818-0610
Homepage URL
nao@orthomedico.jp
Sponsor or person
Institute
ORTHOMEDICO Inc.
Institute
Department
Personal name
Funding Source
Organization
Toyo Sugar Refining Co., Ltd.
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)
IRB Contact (For public release)
Organization
The ethical committee of the Takara Clinic, Medical Corporation Seishinkai
Address
9F Taisei Building, 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan.
Tel
03-5793-3623
info@takara-clinic.com
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
| 2019 | Year | 05 | Month | 31 | 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
44
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 | 05 | Month | 13 | Day |
Date of IRB
| 2019 | Year | 05 | Month | 13 | Day |
Anticipated trial start date
| 2019 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 11 | Month | 15 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 05 | Month | 31 | Day |
Last modified on
| 2020 | Year | 03 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042062
