UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046202 |
|---|---|
| Receipt number | R000052728 |
| Scientific Title | Evaluation of the Effect of Flaxseed Lignan on Blood Cholesterol - A randomized, double-blind, parallel-group study |
| Date of disclosure of the study information | 2022/01/27 |
| Last modified on | 2023/04/07 12:52:39 |
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Basic information
Public title
Evaluation of the Effect of Flaxseed Lignan on Blood Cholesterol - A randomized, double-blind, parallel-group study -
Acronym
Evaluation of the Effect of Flaxseed Lignan on Blood Cholesterol - A randomized, double-blind, parallel-group study
Scientific Title
Evaluation of the Effect of Flaxseed Lignan on Blood Cholesterol - A randomized, double-blind, parallel-group study
Scientific Title:Acronym
Evaluation of the Effect of Flaxseed Lignan on Blood Cholesterol - A randomized, double-blind, parallel-group study
Region
| Japan |
Condition
Condition
healthy person
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effect of continuous intake of flaxseed lignan (secoisolariciresinol diglucoside: SDG) on blood cholesterol levels.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Low-density lipoprotein cholesterol
Key secondary outcomes
Total cholesterol
High-density lipoprotein cholesterol
LDL/HDL ratio
Liver function markers in blood (Aspartate transaminase,Alanine aminotransferase,Gamma-glutamyl transpeptidase)
Triglyceride
Systolic blood pressure, diastolic blood pressure
Heart rate
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
Secoisolariciresinol diglucoside (SDG) 60mg (2 capsules once a day)
Interventions/Control_2
Placebo food (2 capsules once a day)
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
| 20 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Males and females between the ages of 20-65 years at the time of consent.
2) Those who are able to consume the test meal continuously.
3) Those whose blood LDL cholesterol level is between 120 mg/dl and 140 mg/dl.
4) Those with a blood HDL cholesterol level of 40 mg/dl or higher.
5) Those who are concerned about maintaining the health of their blood vessels.
6) Those who can avoid binge drinking and excessive exercise during the study period and lead the same lifestyle (diet, exercise, etc.) as before the study period.
7) Those who have received sufficient explanation of the purpose and content of this study, have the ability to consent, and can voluntarily volunteer to participate with a good understanding of the study, and agree to participate in this study in writing.
Key exclusion criteria
1) Those who show allergic reactions to flaxseed.
2) Those who are in the habit of consuming large amounts of flaxseed and the Study Food Ingredients (SDG).
3) Those who are pregnant or intend to become pregnant during the study period, or those who are lactating.
4) Those who have participated in other clinical studies within 3 months of consent and those who plan to participate in other clinical studies during the study period.
5) Subjects whose anthropometric, physical, or clinical values in the preliminary examination are significantly out of the reference range.
6) Those who regularly use medicines, food for specified health use, functional food, or health food that may affect the evaluation items.
7) Those who have a history of drug dependence or alcohol dependence, or a current medical history.
8) Those who are undergoing treatment for a disease, or have a history of a serious disease that required medication.
9) Patients with serious diseases such as diabetes, hepatic disease, renal disease, or cardiac disease, or those with a history of such diseases.
10) Others who are judged by the principal investigator or sub-investigator to be inappropriate for the study (the study may increase the risk to the research subjects or may not provide sufficient data).
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Kazuhiko |
| Middle name | |
| Last name | Aida |
Organization
NIPPN CORPORATION
Division name
Innovation Center, Central Research Laboratory
Zip code
243-0041
Address
5-1-3 Midorigaoka, Atsugi City, Kanagawa Prefecture
TEL
046-222-6963
kaida@nippn.co.jp
Public contact
Name of contact person
| 1st name | Kazuhiro |
| Middle name | |
| Last name | Ohno |
Organization
Clinical Creative Co., Ltd.
Division name
Pharmaceutical Development Division
Zip code
062-0933
Address
1-12-102, Hiragishi 3-13-1-12, Toyohira-ku, Sapporo City, Hokkaido
TEL
090-3116-6218
Homepage URL
k-ohno@cli-creative.com
Sponsor or person
Institute
Clinical Creative Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
NIPPN CORPORATION
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Sapporo Yurinokai Hospital Clinical Trial Review Committee
Address
11-186 Yurigahara, Kita-ku, Sapporo-shi, Hokkaido
Tel
011-771-1501
info@yurinokai.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 札幌百合の会病院（北海道）
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 01 | Month | 27 | 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
| 2021 | Year | 06 | Month | 21 | Day |
Date of IRB
| 2021 | Year | 07 | Month | 28 | Day |
Anticipated trial start date
| 2022 | Year | 01 | Month | 27 | Day |
Last follow-up date
| 2022 | Year | 06 | Month | 18 | 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 | 11 | Month | 26 | Day |
Last modified on
| 2023 | Year | 04 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052728
