UMIN-CTR Clinical Trial

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
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	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
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	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050950