UMIN-CTR Clinical Trial

Basic information
Public title	A study to evaluate effects of daily test food containing plant extracts on blood glucose level in healthy adult subjects
Acronym	A study to evaluate effects of daily test food containing plant extracts on blood glucose level in healthy adult subjects
Scientific Title	A study to evaluate effects of daily test food containing plant extracts on blood glucose level in healthy adult subjects
Scientific Title:Acronym	A study to evaluate effects of daily test food containing plant extracts on blood glucose level in healthy adult subjects
Region	Japan

Condition
Condition	N/A
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	This study examine the effect of 12-weeks ingestion of a food containing plant extracts on blood glucose level in a healthy adult male and female
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Pre-intervention (baseline) and at 4, 8, 12 weeks in the intervention Area under the curve (AUC) of blood glucose level
Key secondary outcomes	Pre-intervention (baseline) and at 4, 8, 12 weeks in the intervention 1. Matsuda-index 2. Homeostasis model assessment of insulin resistance (HOMA-IR) 3. Fasting blood glucose level 4. Hemoglobin A1c (HbA1c) 5. High sensitive C-reactive protein (CRP) 6. Body weight 7. Body mass index (BMI)

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	Oral injection of the test product with plant extracts (2 capsules per day; 12 weeks)
Interventions/Control_2	Oral injection of the test product without plant extracts (2 capsules per day; 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	40 years-old <=
Age-upper limit	70 years-old >
Gender	Male and Female
Key inclusion criteria	(1) Healthy male and female subjects (>=40 to <70 years of age) (2) Subjects whose BMI values are between normal-high and obesity class 1 (>=23 to <30 kg/m2) (3) Subjects whose fasting blood glucose levels are <126 mg/dL and 2-hour blood glucose levels are <200 mg/dL during oral glucose tolerance test (4) Subjects who participate in this study with a written informed consent
Key exclusion criteria	(1) Subjects who have dietary carbohydrate restriction and try to lose weight or who plan to have dietary carbohydrate restriction and lose weight during the scheduled study period (2) Subjects who consecutively intake pharmaceutical and healthcare foods (which is possible to influence the results of this study) at 3 or more times per week (3) Subjects who plan to change their daily habit (diet, exercise) and living environment (changing residence, employee relocation, et al.) during the scheduled study period (4) Subjects with extremely irregular dietary habits (5) Subjects with excessive alcohol intake (6) Subjects with excessive smoking (7) Subjects who are positive for hepatitis C virus antibody or hepatitis B surface antigen (8) Subjects who allergies to medication or foods (especially soybean and gelatin) (9) Subjects who are participating in another trial, have participated in the past 4 weeks, or plan to participate in another trial during the scheduled study period (10) Females who have pregnancy, lactation, or plan to have pregnancy (11) Subjects who receive medical treatment or have a history of severe disease (12) Subjects who have made a platelet donation or a blood donation of 200 mL within one month prior to this study (13) Males who have made a blood donation of 400 mL within three months (14) Females who have made a blood donation of 400 mL within four months (15) Males who have made a blood donation over an amount (1200 mL minus the estimated volume of blood collected during to this study) within one year prior to this study (16) Females who have made a blood donation over an amount (800 mL minus the estimated volume of blood collected during to this study) within one year prior to this study (17) Subjects judged to be unsuitable for the study for other reasons by the investigators
Target sample size	110

Research contact person
Name of lead principal investigator	1st name Yoshihiro Middle name Last name Yamamoto
Organization	House Wellness Foods Corporation
Division name	Research & Development Institute
Zip code	664-0011
Address	Imoji 3-20, Itami, Hyogo, Japan
TEL	072-778-1127
Email	Yamamoto_Yoshihiro@house-wf.co.jp

Public contact
Name of contact person	1st name Ryusei Middle name Last name Uchio
Organization	House Wellness Foods Corporation
Division name	Research & Development Institute
Zip code	664-0011
Address	Imoji 3-20, Itami, Hyogo, Japan
TEL	072-778-1127
Homepage URL
Email	Uchio_Ryusei@house-wf.co.jp

Sponsor
Institute	Research & Development Institute, House Wellness Foods Corporation
Institute
Department

Funding Source
Organization	House Wellness Foods Corporation
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	Institutional Review Board of Chiyoda Paramedical Care Clinic
Address	2F Sanwa-Uchi-Kanda Building, 3-3-5 Uchi-Kanda, Chiyoda-ku, Tokyo 101-0047, Japan
Tel	03-5297-5548
Email	IRB@cpcc.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	2021 Year 08 Month 12 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	110
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 18 Day
Date of IRB	2021 Year 06 Month 18 Day
Anticipated trial start date	2021 Year 08 Month 12 Day
Last follow-up date	2021 Year 12 Month 12 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 10 Day
Last modified on	2022 Year 08 Month 16 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000051492