UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044608 |
|---|---|
| Receipt number | R000050950 |
| Scientific Title | Examination of appetite suppression in healthy subjects by consumption of the test food: An open-label trial |
| Date of disclosure of the study information | 2021/06/23 |
| Last modified on | 2022/09/22 11:37:15 |
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Basic information
Public title
Examination of appetite suppression in healthy subjects by consumption of the test food
Acronym
Examination of appetite suppression in healthy subjects by consumption of the test food
Scientific Title
Examination of appetite suppression in healthy subjects by consumption of the test food: An open-label trial
Scientific Title:Acronym
Examination of appetite suppression in healthy subjects by consumption 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 suppression effect of appetite and weight loss in healthy subjects with consumption of the test food.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The measured values of body weight at 8 weeks after consumption (8w)
Key secondary outcomes
The measured values of the visual analogue scale (VAS) score (satiety, hunger, fullness, desire to eat richly flavored food, constipation, feeling refreshed during defecation, lightness of body, skin moisture, skin dullness, skin firmness and elasticity), nutrition-related items {weight, energy, moisture, protein, amino acid composition protein, fat, triglyceride (TG) equivalents, saturated fatty acids, monounsaturated fatty acids, polyunsaturated fatty acids, cholesterol, carbohydrates, available carbohydrates (monosaccharide equivalents), soluble dietary fiber, insoluble dietary fiber, total dietary fiber}, body mass index (BMI) and body fat percentage at 8w
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Duration: 8 weeks
Test food: Food containing basil seed
Administration: Take 2 g twice per day within 1 hour before lunch and dinner. Add about 150 mL of water into 1 packet (2 g), stir well and allow to swell before taking.
* If you forget to take the test food, take it as soon as you remember within the day.
Interventions/Control_2
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. Japanese
2. Men or women
3. Subjects aged 20 years old or more
4. Healthy subjects
5. Subjects who are judged as eligible to participate in the study by the physician
6. Subjects whose BMI are between 25 kg/m2 or more and less than 30 kg/m2 at screening (Scr)
7. For subjects whose body weight are relatively heavy at Scr, taking account of the value of body fat percentage and the VAS score (satiety)
Key exclusion criteria
1. Subjects who have at least one previous medical history of malignant tumor, heart failure or myocardial infarction
2. Subjects who have a pacemaker or an implantable cardioverter defibrillator (ICD)
3. Subjects who are currently under the treatment for either cardiac arrhythmia, hepatic disorder, renal disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension or other chronic diseases
4. Subjects who take "Foods for Specified Health Uses", "Foods with Functional Claims", or other functional food/beverage in daily use
5. Subjects who are currently taking medications (including herbal medicines) and supplements, particularly taking antihypertensive drugs, anticoagulants and antiplatelet drugs in daily
6. Subjects who are allergic to medicines and/or the test food related products, particularly basil
7. Subjects who are scheduled for surgery during the consumption or within 2 weeks after the end of consumption
8. Subjects who are pregnant, breast-feeding, or planning to become pregnant after the agreement to participate in this trial
9. Subjects who have been enrolled in other clinical trials within the last 28 days 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
10
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
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
nao@orthomedico.jp
Sponsor or person
Institute
ORTHOMEDICO Inc.
Institute
Department
Personal name
Funding Source
Organization
SHIRATORI Pharmaceutical 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
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
| 2021 | Year | 06 | Month | 23 | 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
11
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
| 2021 | Year | 06 | Month | 16 | Day |
Date of IRB
| 2021 | Year | 06 | Month | 16 | Day |
Anticipated trial start date
| 2021 | Year | 06 | Month | 24 | Day |
Last follow-up date
| 2021 | Year | 11 | Month | 14 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 06 | Month | 21 | Day |
Last modified on
| 2022 | Year | 09 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050950
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