UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057051 |
|---|---|
| Receipt number | R000065205 |
| Scientific Title | Single-arm open-label study to evaluate the effect of seaweed (Ascophyllum nodosum) extract on the suppression of postprandial triglyceride elevation |
| Date of disclosure of the study information | 2025/02/17 |
| Last modified on | 2025/03/31 14:12:33 |
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Basic information
Public title
Open-label study to confirm suppression of postprandial triglycerides elevation by seaweed extract supplementation
Acronym
Open-label study to confirm suppression of postprandial triglycerides elevation by seaweed extract supplementation
Scientific Title
Single-arm open-label study to evaluate the effect of seaweed (Ascophyllum nodosum) extract on the suppression of postprandial triglyceride elevation
Scientific Title:Acronym
Single-arm open-label study to evaluate the effect of seaweed (Ascophyllum nodosum) extract on the suppression of postprandial triglyceride elevation
Region
| Japan |
Condition
Condition
None (Healthy adults)
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect of seaweed extract intake on postprandial triglycerides elevation in healthy Japanese men and women.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
AUC of postprandial triglyceride: before and 1, 2, 3, 4, 5, and 6 hours after high fat diet
Key secondary outcomes
Efficacy
postprandial triglyceride: before and 1, 2, 3, 4, 5, and 6 hours after high fat diet
Cmax of postprandial triglyceride, Tmax of postprandial triglyceride
Safety
Incidence of side effects and adverse events: after intake
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Test food: Acid resistant hard capsule containing 40 mg seaweed (Ascophyllum nodosum) extract
Intake: 1 capsule
Intake period: 1 time (after blood collection before high fat diet intake)
Load food: high fat diet (butter roll, lard and corn soup)
Interventions/Control_2
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Healthy Japanese males and females over 20 years of age at the time of consent.
2. Participants with fasting triglycerides between 30 mg/dL and 150 mg/dL within the last 6 months.
3. Participants who have been fully informed of the purpose and content of this study and who have signed an informed consent form prior to the start of this study.
Key exclusion criteria
1. Those who are currently being treated for a serious illness.
2. Those receiving treatment, medication, or lifestyle intervention from a doctor due to dyslipidemia or diabetes.
3. Those suffering from a medical condition that may affect the test items and who are currently undergoing treatment at a medical facility.
4. Participants with food allergies or who may have an allergic reaction to the test food and high fat diet.
5. Those who regularly consume medicines or quasi-drugs that may affect the test items.
6. Those who regularly consume health foods (foods for specified health uses, food with nutrient function claims, foods with functional claims, dietary supplements, etc.) that may affect the test items.
7. Those who participate in other studies or who have participated in other studies within the past one month.
8. Pregnant, lactating, or wishing to become pregnant.
9. Those who intends to participate in other clinical studies during this study period.
10.Those who are unable to maintain their daily lifestyle (diet, exercise, smoking etc.).
11.Those determined by the principal investigator to be inappropriate in this study.
Target sample size
16
Research contact person
Name of lead principal investigator
| 1st name | Tadashi |
| Middle name | |
| Last name | Watanabe |
Organization
Watanabe Hospital
Division name
Surgery
Zip code
144-0043
Address
1-5-16, Haneda, Ota-ku, Tokyo, Japan
TEL
03-3741-0223
wnb.cto@gmail.com
Public contact
Name of contact person
| 1st name | Ryuto |
| Middle name | |
| Last name | Takahashi |
Organization
Riken Vitamin Co., Ltd.
Division name
Healthcare Unit
Zip code
160-0004
Address
1-6-1, Yotsuya, Shinjuku-ku, Tokyo, Japan
TEL
03-5362-1334
Homepage URL
ryu_takahashi@rike-vita.co.jp
Sponsor or person
Institute
Riken Vitamin Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Riken Vitamin Co., Ltd.
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
Ethics Review Board of Medical Corporation Watanabe Hospital
Address
1-5-16, Haneda, Ota-ku, Tokyo, Japan
Tel
03-3741-0223
food-contact@apoplus.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
| 2025 | Year | 02 | Month | 17 | 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
| 2025 | Year | 01 | Month | 31 | Day |
Date of IRB
| 2025 | Year | 02 | Month | 12 | Day |
Anticipated trial start date
| 2025 | Year | 02 | Month | 22 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 02 | Month | 17 | Day |
Last modified on
| 2025 | Year | 03 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065205
