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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000036909
Receipt No. 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 2019/08/27

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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
Email 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
Email nao@orthomedico.jp

Sponsor
Institute ORTHOMEDICO Inc.
Institute
Department

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
Email 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 No longer recruiting
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
2019 Year 08 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042062

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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