UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053623 |
|---|---|
| Receipt number | R000061196 |
| Scientific Title | Investigation of the Impacts on Body Composition through Continued Consumption of Garcinia cambogia Tablets - A Randomized, Double-blind, Placebo-controlled, Parallel-group Comparative Study - |
| Date of disclosure of the study information | 2024/03/24 |
| Last modified on | 2024/08/01 10:28:59 |
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Basic information
Public title
Investigation of the Impacts on Body Composition through Continued Consumption of Garcinia cambogia Tablets
- A Randomized, Double-blind, Placebo-controlled, Parallel-group Comparative Study -
Acronym
Investigation of the Impacts on Body Composition through Continued Consumption of Garcinia cambogia Tablets
Scientific Title
Investigation of the Impacts on Body Composition through Continued Consumption of Garcinia cambogia Tablets
- A Randomized, Double-blind, Placebo-controlled, Parallel-group Comparative Study -
Scientific Title:Acronym
Investigation of the Impacts on Body Composition through Continued Consumption of Garcinia cambogia Tablets
- A Randomized, Double-blind, Placebo-controlled, Parallel-group Comparative Study -
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Aim to investigate the impacts on body composition through continued consumption of the test food product for 12 weeks in males and females aged 20 or over but under 65, with a mild tendency towards obesity.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Body fat area (visceral fat area, subcutaneous fat area, total fat area)
Key secondary outcomes
-Weight, BMI
-Body fat percentage
-Perimeter of each part of body (waist, hip, thigh, upper arm, neck)
-Blood tests (TG, LDL-C, blood glucose level, uric acid, ALT, AST)
-Questionnaire evaluation
-Anti-glycation
-Physical activity monitored via a smartwatch
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Subjects will take three tablets of the test food product once daily for 12 weeks.
Interventions/Control_2
Subjects will take three tablets of the placebo food product once daily for 12 weeks.
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. Age: 20 or over but under 65 (at the time of consent)
2. Gender: Males and females with Japanese nationality
3. Individuals with a BMI of 23.0 kg/m^2 or more but less than 30.0 kg/m^2
4. Ability to input electronic diaries through smartphones or PCs
5. Individuals who after receiving a comprehensive explanation and understanding the study objectives and details voluntarily consented to participate in writing
Key exclusion criteria
1. Those currently receiving medical or herbal treatment for a disease (however, chronic use is permissible)
2. Those currently on diet or exercise therapy under the supervision of a doctor
3. Those with severe diseases, current or past
4. Those with surgical history on the digestive tract (however, appendicitis is acceptable)
5. Those currently consuming quasi-drugs, Foods for Specified Health Use, Foods with Functional Claims, health foods or supplements that may affect obesity, hyperlipidemia, and lipid metabolism
6. Those regularly(nearly 3 times a week or more) consuming quasi-drugs, Foods for Specified Health Use, Foods with Functional Claims, health foods or supplements other than the ones listed above unless they can stop after consent is obtained
7. Those unable to abstain from alcohol the day before the test
8. Those with present or past food or drug allergy
9. Those with excessive drinking habits (approximately 40g or more alcohol consumption a day)
10. Those with heavy smoking habits (approximately 21 or more cigarettes per day)
11. Those with shift work that involves night shifts
12. Those with metal implanted in the body through surgery
13. Those with a heart pacemaker or implanted medical device
14. Those with claustrophobia
15. Those planning to significantly change lifestyle habits (diet, sleep, exercise habits etc.) during this trial period, such as through long-term travel
16. Those currently pregnant or breastfeeding, or wishing to get pregnant during this trial period
17. Those participating in clinical trials of other pharmaceutical products or health foods, or those within 4 weeks of trial completion, or intending to participate in other clinical trials after the consent for this trial
18. Others whom the study physician deem inappropriate as subjects for the trial
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Kazuhiro |
| Middle name | |
| Last name | Maejima |
Organization
NIPPON SHINYAKU CO., LTD.
Division name
Food Science Labs.
Zip code
601-8550
Address
Nishinosho-Monguchi-cho,Kisshoin, Minami-ku, Kyoto
TEL
075-321-9027
k.maejima@po.nippon-shinyaku.co.jp
Public contact
Name of contact person
| 1st name | Yoshitada |
| Middle name | |
| Last name | Hira |
Organization
IMEQRD Co., Ltd
Division name
Planning and Sales Department
Zip code
104-0061
Address
6-2-1 Ginza Chuo-ku Tokyo Japan
TEL
03-6704-5968
Homepage URL
https://imeqrd.co.jp/
clinical-trial@imeqrd.co.jp
Sponsor or person
Institute
IMEQRD Co. Ltd.
Institute
Department
Personal name
Funding Source
Organization
NIPPON SHINYAKU CO., LTD.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Suda Clinic institutional review board
Address
2-8-14,Takadanobaba,Shinjyuku,Tokyo
Tel
03-6704-5968
jimukyoku@imeqrd.co.jp
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 | 03 | Month | 24 | 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
Completed
Date of protocol fixation
| 2023 | Year | 12 | Month | 18 | Day |
Date of IRB
| 2024 | Year | 01 | Month | 30 | Day |
Anticipated trial start date
| 2024 | Year | 03 | Month | 25 | Day |
Last follow-up date
| 2024 | Year | 08 | Month | 01 | 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 | 02 | Month | 15 | Day |
Last modified on
| 2024 | Year | 08 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061196
