UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054343 |
|---|---|
| Receipt number | R000061969 |
| Scientific Title | A dose-finding study on the effects of test foods on body fat reduction: A randomized, double-blind, placebo-controlled, parallel-group trial. |
| Date of disclosure of the study information | 2024/05/16 |
| Last modified on | 2024/05/16 10:02:10 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
A dose-finding study on the effects of test foods on body fat reduction: A randomized, double-blind, placebo-controlled, parallel-group trial.
Acronym
A dose-finding study on the effects of test foods on body fat reduction: A randomized, double-blind, placebo-controlled, parallel-group trial.
Scientific Title
A dose-finding study on the effects of test foods on body fat reduction: A randomized, double-blind, placebo-controlled, parallel-group trial.
Scientific Title:Acronym
A dose-finding study on the effects of test foods on body fat reduction: A randomized, double-blind, placebo-controlled, parallel-group trial.
Region
| Japan |
Condition
Condition
Healthy volunteers
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effects of consumption of the test foods on body fat reduction
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Visceral fat area by abdominal CT imaging
Key secondary outcomes
Subcutaneous and total fat area by abdominal CT imaging, body weight, BMI, body fat mass, body fat percentage, waist circumference, blood glucose, plasma level of active GLP-1, serum levels of insulin and adiponectin
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Intake of test food 1 for twelve weeks (one packet a day)
Interventions/Control_2
Intake of test food 2 for twelve weeks (one packet a day)
Interventions/Control_3
Intake of placebo for twelve weeks (one packet a day)
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) Males and females whose age of 20 years or more and less than 65 years
2) Subjects with a BMI of 25 kg/m2 or more and less than 30 kg/m2
3) Subjects receiving a sufficient briefing of the objective and content of the present study, fully understanding and agreeing to voluntarily participate in the study and being able to personally sign a written informed consent
Key exclusion criteria
1)Shift workers
2)Subjects with irregular eating habits
3)Subjects exercising for the purpose of weight loss or muscle building
4)Subjects whose exercise habits are likely to change significantly during the examination and subjects who will be relocating, traveling for more than one week during the examination
5)Subjects receiving a medical treatment for serious cardio-vascular, hepatic, renal, respiratory, endocrine or metabolic disorders or having a medical history of these disorders
6)Subjects receiving a medical treatment for chronic diseases such as dyslipidemia, hypertension, and diabetes
7)Subjects diagnosed with chronic constipation
8)Subjects regularly taking medicines and quasi-drugs that may affect the evaluation of this study, such as body fat, triglycerides, body weight, cholesterol, blood glucose, and energy metabolism
9)Subjects regularly taking foods for specified health uses or foods with functional claims that may affect the evaluation of this study, such as body fat, triglycerides, body weight, cholesterol, blood glucose, and energy metabolism
10)Subjects having the possibility of developing allergic symptoms by the test food and prescribed diet
11)Subjects with claustrophobia, subjects with metal in the CT scan measurement site and subjects with implanted medical devices such as cardiac pacemakers, etc.
12)Subjects consuming more than 40 g/day of alcohol for men and 20 g/day for women
13)Subjects smoking excessively (21 or more cigarettes/day)
14)Subjects having a blood draw of 200 mL or more within 1 month prior to study entry or a blood draw of 400 mL or more within 3 months prior to study entry.
15)Subjects who took part in another clinical study within 3 months prior to the start of this study, who are currently taking part in another clinical study, or who plan to participate during this study.
16)Subjects who are pregnant or lactating, or intending to become pregnant during the study
17)Subjects deemed unsuitable by the investigator
Target sample size
45
Research contact person
Name of lead principal investigator
| 1st name | Mamiko |
| Middle name | |
| Last name | Kohno |
Organization
Morishita Jintan Co., Ltd.
Division name
Product Research Group, Research and Development Department, Business Management Headquarters
Zip code
572-0128
Address
2-11-1, Tsudayamate, Hirakata-shi, Osaka
TEL
072-800-1044
m_kohno@jintan.co.jp
Public contact
Name of contact person
| 1st name | Masaki |
| Middle name | |
| Last name | Wakabayashi |
Organization
Soiken Inc.
Division name
R&D Division
Zip code
560-0082
Address
Senri Life Science Center 13F, 1-4-2, Shinsenri-higashimachi, Toyonaka-shi, Osaka
TEL
06-6871-8888
Homepage URL
wakabayashi_masaki@soiken.com
Sponsor or person
Institute
Morishita Jintan Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
None
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
IRB of Fukuda Clinic
Address
Shin-Osaka brick building 2F, 1-6-1 Miyahara, Yodogawa-ku, Osaka-shi, Osaka
Tel
06-6398-0203
fukudaclinicIRB@gmail.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
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 05 | 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
Preinitiation
Date of protocol fixation
| 2024 | Year | 03 | Month | 14 | Day |
Date of IRB
| 2024 | Year | 03 | Month | 16 | Day |
Anticipated trial start date
| 2024 | Year | 08 | Month | 31 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 05 | Month | 09 | Day |
Last modified on
| 2024 | Year | 05 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061969
