UMIN-CTR Clinical Trial

Basic information
Public title	A study to evaluate effects of daily test food on blood parameters in a healthy adult subjects
Acronym	A study to evaluate effects of daily test food on blood parameters in a healthy adult subjects
Scientific Title	A study to evaluate effects of daily test food containing plant extracts on blood biochemical parameters in a healthy adult subjects
Scientific Title:Acronym	A study to evaluate effects of daily test food containing plant extracts on blood biochemical parameters in a 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 biochemical parameters in a healthy adult males and females
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	At 0, 4, 8, 12 weeks in the intervention (1) C-reactive protein (CRP) (2) Tumor necrosis factor-alpha (TNF-alpha) (3) Interleukin-6 (IL-6) (4) Soluble vascular cell adhesion molecule-1 (sVCAM-1)
Key secondary outcomes	At 0, 4, 8, 12 weeks in the intervention (1) Complement C3 (C3) (2) Complement C4 (C4) (3) Fibrinogen (FIB) (4) Glucose (GLC) (5) Hemoglobin A1c (HbA1c) (6) Insulin (IRI) (7) Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) (8) Glucagon (9) Total cholesterol (T-Cho) (10) Low-density lipoprotein cholesterol (LDL-Cho) (11) High-density lipoprotein cholesterol (HDL-Cho) (12) High-density lipoprotein cholesterol /low-density lipoprotein cholesterol ratio (HDL/LDL ratio) (13) Non-high-density lipoprotein cholesterol (non-HDL Cho) (14) Adiponectin (15) Leptin (16) Amyloid-beta peptide 1-40 (A-beta40) (17) Amyloid-beta peptide 1-42 (A-beta42) (18) Mild cognitive impairment (MCI) screening (apolipoprotein A1 (ApoA1), inactive form of C3, transthyretin) (19) Addenbrooke's Cognitive Examination III(ACE-III) (20) Profile of mood states-2nd edition (POMS-2) short versions (21) MOS 36-Item short form version 2 (SF-36v2; acute)

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 a plant extract (2 tablets per day; 12 weeks)
Interventions/Control_2	Oral injection of the test product without a plant extract (2 tablets 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	50 years-old <=
Age-upper limit	69 years-old >=
Gender	Male and Female
Key inclusion criteria	(1) Males and females aged 50 to 69 years when informed consent (2) Subjects whose BMI values are between normal-high and obesity class 1 (>=23 and <30) (3) Subjects whose blood glucose levels <126 mg/dL (4) Subjects whose blood high-density cholesterol (HDL-Cho) levels >=35 mg/dL (5) Subjects who participate in this study with a written informed consent
Key exclusion criteria	(1) Subjects who are positive for hepatitis C virus antibody or hepatitis B surface antigen (2) Subjects using medications or health foods that could possibly influence the results of this study (3) Subjects with a history of heart disease, liver disease, kidney disease, or gastrointestinal disease (4) Subjectswith a history of circulatory disease (5) Subjects with excessive alcohol intake. (6) Subjects who are excessive smoker. (7) Subjects who have extremely irregular dietary habits (8) Subjects who allergies to medications 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) Subjects who have made a blood donation within one month prior to this study (11) Males who have made a blood donation of 400 mL within three months prior to this study (12) Females who have made a blood donation of 400 mL within four months prior to this study (13) Males who have made a blood donation over an amount (1200 mL minus the estimated volume of blood collected during the study) within one year prior to this study (14) Females who have made a blood donation over an amount (800 mL minus the estimated volume of blood collected during the study) within one year prior to this study (15) Persons judged to be unsuitable for the study for other reasons by the investigators.
Target sample size	90

Research contact person
Name of lead principal investigator	1st name Yoshihiro Middle name Last name Yamamoto
Organization	House Wellness Foods Corporation
Division name	Research and 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 and 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 Sanwauchikannda Building, 3-3-5 Uchikanda 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	2019 Year 07 Month 16 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	Completed
Date of protocol fixation	2019 Year 06 Month 24 Day
Date of IRB	2019 Year 06 Month 21 Day
Anticipated trial start date	2019 Year 07 Month 16 Day
Last follow-up date	2019 Year 12 Month 08 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2019 Year 07 Month 14 Day
Last modified on	2020 Year 08 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042607