UMIN-CTR Clinical Trial

Basic information
Public title	Effect of health instructions and the test food containing Salacia extract
Acronym	Effect of health instructions and the test food containing Salacia extract
Scientific Title	Effect of health instructions and the test food containing Salacia extract
Scientific Title:Acronym	Effect of health instructions and the test food containing Salacia extract
Region	Japan

Condition
Condition	Subjects of Specific Health Guidance
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the effect of health instructions and the test food containing Salacia extract
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	HbA1c, Fasting blood glucose level, Blood insulin level, HOMA-R
Key secondary outcomes	Mini Nutritional Assessment, Body weight, BMI, Abdominal circumference, N-terminal telopeptide, Osteocalcin

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Food Behavior,custom
Interventions/Control_1	Health instructions for 6 months
Interventions/Control_2	Health instructions and intake of the test food containing Salacia extract for 6 months
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	40 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1)Subjects of Specific Health Guidance 2)Subjects whose fasting blood glucose levels are not less than 100 mg/dL or HbA1c are not less than 5.6% 3)Subjects who have understood the purpose and contents of the study and agree to participate by signing the written informed consent
Key exclusion criteria	None
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Kazuhiro Middle name Last name Nishimura
Organization	Komazawa Women's University
Division name	Faculty of Human Health, Department of Health and Nutrition Sciences
Zip code	206-8511
Address	238 Sakahama, Inagi-shi, Tokyo
TEL	042-350-7111
Email	k-nishimura@komajo.ac.jp

Public contact
Name of contact person	1st name Haruka Middle name Last name Hamasaki
Organization	KOBAYASHI Pharmaceutical Co., Ltd.
Division name	Research & Development Dept., Healthcare Division
Zip code	567-0057
Address	1-30-3, Toyokawa, Ibaraki-city, Osaka
TEL	072-640-0131
Homepage URL
Email	h.hamasaki@kobayashi.co.jp

Sponsor
Institute	Komazawa Women's University
Institute
Department

Funding Source
Organization	KOBAYASHI Pharmaceutical 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	Ryokufuso Hospital
Address	3-31-1, Hagiyama-cho, Hihashimurayama-city, Tokyo
Tel	042-392-1101
Email	keiko-5@kg7.so-net.ne.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	2021 Year 08 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
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	Terminated
Date of protocol fixation	2021 Year 07 Month 26 Day
Date of IRB	2021 Year 08 Month 16 Day
Anticipated trial start date	2021 Year 08 Month 23 Day
Last follow-up date	2022 Year 03 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	2021 Year 08 Month 20 Day
Last modified on	2022 Year 08 Month 22 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000051257