UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037370 |
|---|---|
| Receipt number | R000042607 |
| Scientific Title | A study to evaluate effects of daily test food containing plant extracts on blood biochemical parameters in a healthy adult subjects |
| Date of disclosure of the study information | 2019/07/16 |
| Last modified on | 2020/08/17 12:31:08 |
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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
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
Uchio_Ryusei@house-wf.co.jp
Sponsor or person
Institute
Research & Development Institute, House Wellness Foods Corporation
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042607
