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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000042469
Receipt No. R000048478
Scientific Title Effects of consumption of the test food on the visceral fat area in healthy subjects: a randomized, placebo-controlled, double-blind, parallel-group comparison study
Date of disclosure of the study information 2020/11/16
Last modified on 2020/11/17

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Basic information
Public title Effects of consumption of the test food on the visceral fat area in healthy subjects
Acronym Effects of consumption of the test food on the visceral fat area in healthy subjects
Scientific Title Effects of consumption of the test food on the visceral fat area in healthy subjects: a randomized, placebo-controlled, double-blind, parallel-group comparison study
Scientific Title:Acronym Effects of consumption of the test food on the visceral fat area in healthy subjects
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 continuous consumption of the test food on the visceral fat area in healthy subjects
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 at 12 weeks after the start of the test-food consumption (12w)
Key secondary outcomes 1. The visceral fat area at eight weeks after the start of test-food consumption (8w)

2. The subcutaneous fat area, total fat area, body weight, body mass index (BMI), abdominal circumference, waist circumference, body fat percentage, fat mass, lean body mass, and muscle mass at 8w and 12w

3. The serum levels of total cholesterol (T-Ch), high-density lipoprotein cholesterol (HDL), low-density lipoprotein cholesterol (LDL), and triglyceride (TG)

4. Each item of the questionnaire at 4w, 8w, and 12w

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

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 Duration: 12 weeks

Test food: Capsule containing plant extract

Administration: Take three capsules once per day with water immediately before snack or dinner.

*If you forget to take the test food, take it as soon as you remember within the day.
Interventions/Control_2 Duration: 12 weeks

Test food: Capsule not containing plant extract

Administration: Take three capsules once per day with water immediately before snack or dinner.

*If you forget to take the test food, take it 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
65 years-old >
Gender Male and Female
Key inclusion criteria 1. Japanese healthy subjects aged 20 or over to under 65 years old
2. Subjects who have the habit of snacking (i.e., the habit of consuming fructose-containing foods)
3. Subjects who are judged as eligible to participate in the study by the physician
4. Subjects whose fructose intakes are relatively high in the dietary survey during the last three days before screening (before consumption; Scr)
5. Subjects whose values of BMI are 23 kg/m2 or more and less than 30 kg/m2 at Scr
6. Subjects who receive a full explanation of the procedures in the study, understand the explanation, and provide informed consent signed by themselves
7. Among the subjects who met the inclusion criteria, select 198 of them as the combination of the subjects with the minimum standard deviation of the visceral fat area at Scr
Key exclusion criteria Subjects (who)
1.undergoing medical treatment or have a medical history of malignant tumor, heart failure, and myocardial infarction
2.have a pacemaker or an implantable cardioverter defibrillator
3.undergoing treatment for any of the following chronic disease: cardiac arrhythmia, liver disorder, kidney disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases
4.take "Foods for Specified Health Uses", "Foods with Functional Claims", or other functional food/beverage in daily use
5.take herb or supplements with hypoglycemic effects in daily use
6.planning to undergo a surgical operation during the intervention period or within two weeks from the date of finish of the intervention period
7.taking medicines (include herbal medicines) and supplements
8.allergic to medications and/or the test-food-related products
9.have weak stomach and may feel discomfort such as convergence in the stomach, particularly when taking beverages containing tannin such as strong green tea, black tea, or coffee
10.pregnant, lactation, or planning to become pregnant
11.have unhealthy eating habits or irregular rhythm of life
12.drink an excess of alcohol
*weekly average of alcohol intake is more than 60 g/day [Reference materials for the promotion of Health Japan 21 (the second term)]
13.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
14.have donated blood component or 200-mL whole blood within the last one month before the agreement to participate in this trial
15.have donated 400-mL whole blood within the last three month before the agreement to participate in this trial
16.are scheduling to have a total of more than 1,200 mL of blood drawn until the end of this study from the 12 months before the date of consent obtained
17.judged as ineligible to participate in the study by the physician
Target sample size 180

Research contact person
Name of lead principal investigator
1st name Tsuyoshi
Middle name
Last name Takara
Organization Medical Corporation Seishinkai, Takara Clinic
Division name Director
Zip code 141-0022
Address 9F Taisei Bldg., 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan
TEL 03-5793-3623
Email t-takara@takara-clinic.com

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 NAGAOKA CO., LTD.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor Medical Corporation Seishinkai, Takara Clinic

Nerima Medical Association, Minami-machi 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 IRB@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)

南町医院 (東京都)
Nerima Medical Association, Minami-machi Clinic (Tokyo, Japan)

Other administrative information
Date of disclosure of the study information
2020 Year 11 Month 16 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 Open public recruiting
Date of protocol fixation
2020 Year 11 Month 11 Day
Date of IRB
2020 Year 11 Month 11 Day
Anticipated trial start date
2020 Year 11 Month 17 Day
Last follow-up date
2021 Year 06 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 11 Month 16 Day
Last modified on
2020 Year 11 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048478

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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