UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054338 |
|---|---|
| Receipt number | R000062035 |
| Scientific Title | Study on the absorption of isoflavones after ingestion of soy isoflavones extract. -A randomized, double- blind, 2-way, 2-period, cross-over study- |
| Date of disclosure of the study information | 2024/05/09 |
| Last modified on | 2024/11/06 11:47:11 |
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Basic information
Public title
Study on the absorption of isoflavones after ingestion of soy isoflavones extract. -A randomized, double- blind, 2-way, 2-period, cross-over study-
Acronym
Study on the absorption of isoflavones after ingestion of soy isoflavones extract.
Scientific Title
Study on the absorption of isoflavones after ingestion of soy isoflavones extract. -A randomized, double- blind, 2-way, 2-period, cross-over study-
Scientific Title:Acronym
Study on the absorption of isoflavones after ingestion of soy isoflavones extract.
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To study on the improvement effect of isoflavones absorption from soy isoflavones extract by formulation processing.
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
AUC 0-24h for postprandial serum total isoflavones concentrations.
Key secondary outcomes
Serum total isoflavones, daidzein, genistein and glycitein concentrations, AUC at each time point. Cmax and Tmax of Serum total isoflavones, daidzein, genistein and glycitein.
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Intake of soy isoflavones extract (control food, single ingestion) - washout period - intake of soy isoflavones extract (test food, single ingestion).
Interventions/Control_2
Intake of soy isoflavones extract (test food, single ingestion) - washout period - intake of soy isoflavones extract (control food, single ingestion).
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
| 45 | years-old | <= |
Age-upper limit
| 60 | years-old | > |
Gender
Female
Key inclusion criteria
1) Japanese postmenopausal women from 45 to 59 years of age.
2) Subjects whose BMI are more than 18.5 kg/m2 less than 25.0 kg/m2.
3) Subjects who have been fully informed of the purpose and content of the study, fully understand it, agree to voluntarily participate in the study, and are able to sign the consent form.
Key exclusion criteria
1) Subjects with a serious medical history or gastrointestinal surgery.
2) Subjects with diseases affecting digestion/absorption, or with daily symptoms of indigestion, constipation, diarrhea, etc.
3) Subjects have renal, hepatic, cardiac, or other metabolic diseases.
4) Subjects who are undergoing treatment that affects the study, have a disease that requires treatment, or are regular users of pharmaceuticals.
5) Subjects who regularly use drugs or foods that may affect the study.
6) Subjects unable to discontinue soy-containing foods intake from 3 days prior to the start of test foods intake until the end of each period.
7) Subjects unable to consume the test foods and the designated diets in the admission due to preferences, allergies, etc.
8) Subjects are heavy alcohol drinkers or smokers.
9) Subjects who have difficulty collecting blood samples over time.
10) Subjects who underwent a whole blood withdrawal of 200 mL or more within the 4 weeks prior to the start of test foods intake, or 400 mL or more within the 12 weeks prior to the start of the study.
11) Subjects who participated in another clinical trial within 4 weeks prior to the start of test foods intake, and who are currently or who has plans to participate in another clinical trial from the present or until the end of the study.
12) Subjects with irregular sleep or dietary habits due to night work or insomnia.
13) Subjects engaged in intense physical exercise.
14) Subjects who are judged to be unsuitable as subjects by the principal investigator or others.
Target sample size
8
Research contact person
Name of lead principal investigator
| 1st name | Sachiyuki |
| Middle name | |
| Last name | Teramoto |
Organization
FANCL Corporation
Division name
Research Institute
Zip code
244-0806
Address
12-13, Kamishinano, Totsuka-ku, Yokohama, Kanagawa 244-0806, Japan
TEL
045-820-3425
sateramoto@fancl.co.jp
Public contact
Name of contact person
| 1st name | Naoyuki |
| Middle name | |
| Last name | Abe |
Organization
Medical Corporation Jikokai
Division name
Clinical Trial Division
Zip code
003-0011
Address
7-10-30 Chuo 1-jo, Shiroishi-ku, Sapporo, Hokkaido 003-0011, Japan
TEL
011-868-2711
Homepage URL
n-abe@medi-ate.jp
Sponsor or person
Institute
FANCL Corporation
Institute
Department
Personal name
Funding Source
Organization
FANCL Corporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Medical Corporation Jikokai Fukuzumi Internal Medicine Clinic Ethical Review Committee
Address
Ito-Yokado Fukuzumi 5F, 1-2-5 Fukuzumi 2-jo, Toyohira-ku, Sapporo 062-0042, Japan
Tel
011-836-3531
n-abe@medi-ate.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
医療法人社団 慈昂会 白石内科クリニック
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 05 | Month | 09 | 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
| 2024 | Year | 04 | Month | 06 | Day |
Date of IRB
| 2024 | Year | 04 | Month | 15 | Day |
Anticipated trial start date
| 2024 | Year | 05 | Month | 09 | Day |
Last follow-up date
| 2024 | Year | 05 | Month | 17 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 05 | Month | 08 | Day |
Last modified on
| 2024 | Year | 11 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062035
