UMIN-CTR Clinical Trial

Basic information
Public title	The efficacy and safety of test food consumption for 12 weeks on the visceral fat in healthy Japanese subjects
Acronym	The efficacy and safety of test food consumption for 12 weeks on the visceral fat in healthy Japanese subjects
Scientific Title	The efficacy and safety of test food consumption for 12 weeks on the visceral fat in healthy Japanese subjects: a randomized, placebo-controlled, double-blind, parallel-group study
Scientific Title:Acronym	The efficacy and safety of test food consumption for 12 weeks on the visceral fat in healthy Japanese 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 efficacy and safety of test food consumption for 12 weeks on the visceral fat in healthy Japanese subjects
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	1. The measured values of abdominal visceral fat area at 12 weeks after consumption (12w)
Key secondary outcomes	1. The amount of change of abdominal visceral fat area between screening (before consumption; Scr) and 12w 2. The measured values in each of the following items at 12w: abdominal subcutaneous fat area, total abdominal fat area, body weight, body mass index (BMI), abdominal circumference, waist circumference, body fat percentage, fat mass, lean body mass, muscle mass, total cholesterol, high-density lipoprotein (HDL) cholesterol, low-density lipoprotein (LDL) cholesterol, triglyceride (TG), and original questionnaires 3. The amount of change from Scr in each of the following items at 12w: abdominal subcutaneous fat area, total abdominal fat area, body weight, BMI, abdominal circumference, waist circumference, body fat percentage, fat mass, lean body mass, muscle mass, total cholesterol, HDL cholesterol, LDL cholesterol, TG

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: Drink containing beta-hydroxybutyric acid (BHB) Administration: Drink one bottle after breakfast * Daily dose should be taken within the day. If you forget to take the test food, take it as soon as you remember within the day.
Interventions/Control_2	Duration: Test food: Drink not containing BHB Administration: Drink one bottle after breakfast * Daily dose should be taken within the day. 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	Not applicable
Gender	Male and Female
Key inclusion criteria	1. Japanese 2. Men or women 3. Subjects aged 20 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 23 kg/m2 or more and less than 30 kg/m2 at Scr 7. Subjects whose the visceral fat area are relatively large
Key exclusion criteria	1. Subjects who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, and myocardial infarction 2. Subjects who have a pacemaker or an implantable cardioverter defibrillator (ICD) 3. Currently undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disease, kidney disease, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases 4. Subjects who use or take "Foods for Specified Health Uses," "Foods with Functional Claims," or other functional food/beverage in daily 5. Subjects who are currently taking medications (including herbal medicines) and supplements 6. Subjects who are allergic to medicines and/or the test food related products 7. Subjects who have exercise habits three times or more per week 8. Subjects who work late-night shifts and the erratic lifestyle (particularly dietary habits) 9. Subjects who are on excessive dietary restriction, such as not eating carbohydrates at all 10. Subjects who are on a diet 11. Subjects who are pregnant, breast-feeding, and planning to become pregnant 12. 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 13. Subjects who are judged as ineligible to participate in the study by the physician
Target sample size	40

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	OSAKA GAS 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 09 Month 01 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	44
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 08 Month 25 Day
Date of IRB	2021 Year 08 Month 25 Day
Anticipated trial start date	2021 Year 09 Month 02 Day
Last follow-up date	2022 Year 02 Month 13 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 08 Month 31 Day
Last modified on	2022 Year 04 Month 12 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051758