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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000038990
Receipt No. R000044291
Scientific Title Effect of a Food Containing Seaweed Extract Suppress the Increase in Postprandial Triglyceride.
Date of disclosure of the study information 2020/01/31
Last modified on 2019/12/24

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Basic information
Public title Effect of a Food Containing Seaweed Extract Suppress the Increase in Postprandial Triglyceride.
Acronym Effect of a Food Containing Seaweed Extract Suppress the Increase in Postprandial Triglyceride.
Scientific Title Effect of a Food Containing Seaweed Extract Suppress the Increase in Postprandial Triglyceride.
Scientific Title:Acronym Effect of a Food Containing Seaweed Extract Suppress the Increase in Postprandial Triglyceride.
Region
Japan

Condition
Condition N/A (healthy adults)
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 This study aims to examine effect of a food containing seaweed extract suppress the increase in postprandial triglyceride.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes [1]Efficacy evaluation (changes, increase and decrease of TG, NEFA, lipoprotein fraction, RLP-C, apoB48 [before ingestion of a challenge diet, and 2, 3, 4, 6 hours after ingestion of a challenge diet; AUC and iAUC of TG, NEFA, lipoprotein fraction, RLP-C, apoB48 [observation period I and II]).
Key secondary outcomes *Indexes for safety
[1]Blood pressure, pulsation (screening and before ingestion of a challenge diet).
[2]Weight, body fat percentage, BMI (screening and before ingestion of a challenge diet) .
[3]Doctor's questions (screening, before ingestion of a challenge diet, and 6 hours after ingestion of a challenge diet).
[4]Subject's diary (from one day before ingestion of a challenge diet in observation period I to one day before ingestion of a challenge diet in observation period II).

*Other indexes
[1]Hematologic test (screening).
[2]Blood biochemical test (screening).
[3]Urine analysis (screening).

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
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 [1]Oral ingestion of a test food (1 time).
[2]Oral ingestion of a challenge diet.
[3]Observation.
[4]Washout (over 5 days)
[5]Oral ingestion of a placebo food.
[6]Oral ingestion of a challenge diet.
[7]Observation.
Interventions/Control_2 [1]Oral ingestion of a placebo food.
[2]Oral ingestion of a challenge diet.
[3]Observation.
[4]Washout (over 5 days)
[5]Oral ingestion of a test food (1 time).
[6]Oral ingestion of a challenge diet.
[7]Observation.
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]Japanese males and females aged 20-64 years.
[2]Individuals who are healthy and are not suffered from a chronic malady including skin disease.
[3]Individuals whose triglyceride level is high-normal (120-149 mg/dL) or who are mild hyperlipemia (150-199mg/dL).
[4]Individuals whose written informed consent has been obtained.
[5]Individuals who can visit an inspection facility and be inspected in designated days.
[6]Individuals judged appropriate for the study by the principal.
Key exclusion criteria [1]Individuals using medical products.
[2]Individuals who are or are under treatment or have a history of hyperlipidemia, hypertension, diabetes, mental disabilities, sleep disorder or the other serious dysfunctions.
[3]Individuals who used a drug to treat in the past 1 month (One-shot medicine of a headache, menstrual pain and a cold removes it).
[4]Individuals who have a history of serious hepatopathy, kidney damage, heart disease, lung disease, or blood disease.
[5]Individuals who have digestive organ disease (disease of an appendix is removed).
[6]Individuals whose menstrual period is during the test period and with serious anemia or poor physical condition during the period (only for females).
[7]Individuals whose BMI is over 30kg/m2.
[8]Individuals who donated blood over 200mL in the past 1 month or over 400mL in the past 3 months.
[9]Individuals with serious anemia.
[10]Individuals who are difficult to conduct blood collections over time.
[11]Individuals who are sensitive to test products or causes severe allergy in a food and medical supplies.
[12]Individuals who cannot intake every diet the day before the inspection day or every loading food.
[13]Individuals who are based on average alcohol per 1 day and exceeds 60g/day.
[14]Individuals whose life style will change during the test period (ex. travel for a long time).
[15]Individuals who had a habit to ingest health-promoting foods, foods for specified health uses, health foods, or supplements which adopt to improve lipid metabolism or glucose metabolism in the past 3 months or will ingest those foods during the test period.
[16]Individuals who are or are possibly pregnant, or are lactating.
[17]Individuals who participated in other clinical studies in the past 3 months.
[18]Individuals judged inappropriate for the study by the principal.
Target sample size 84

Research contact person
Name of lead principal investigator
1st name Takahiro
Middle name
Last name Ono
Organization Ueno-Asagao Clinic
Division name Head
Zip code 110-0015
Address 6F Kairaku Building 2-7-5 Higashiueno Taito-ku Tokyo 110-0015, JAPAN
TEL +81-3-6240-1162
Email info@ueno-asagao.clinc

Public contact
Name of contact person
1st name Ryoma
Middle name
Last name Shimizu
Organization TES Holdings Co., Ltd.
Division name Administrative Department of Clinical Trials
Zip code 110-0015
Address 6F Kairaku Building 2-7-5 Higashiueno Taito-ku Tokyo 110-0015, JAPAN
TEL +81-3-6801-8480
Homepage URL
Email r.shimizu@tes-h.co.jp

Sponsor
Institute TES Holdings Co., Ltd.
Institute
Department

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 Ueno-Asagao Clinic Ethical Review Committee
Address 6F Kairaku Building 2-7-5 Higashiueno Taito-ku Tokyo 110-0015, JAPAN
Tel +81-3-6240-1162
Email jimukyoku@tes-h.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
2020 Year 01 Month 31 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 Preinitiation
Date of protocol fixation
2019 Year 12 Month 02 Day
Date of IRB
2019 Year 12 Month 04 Day
Anticipated trial start date
2020 Year 02 Month 02 Day
Last follow-up date
2020 Year 02 Month 16 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 12 Month 25 Day
Last modified on
2019 Year 12 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044291

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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