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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000043114
Receipt No. R000049168
Scientific Title Effect of food containing algae intake on metabolic syndrome related factor : A randomized double-blind placebo-controlled study
Date of disclosure of the study information 2022/01/24
Last modified on 2021/09/30

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Basic information
Public title Effect of food containing algae intake on metabolic syndrome related factor
Acronym Effect of food containing algae intake on metabolic syndrome related factor
Scientific Title Effect of food containing algae intake on metabolic syndrome related factor : A randomized double-blind placebo-controlled study
Scientific Title:Acronym Effect of food containing algae intake on metabolic syndrome related factor
Region
Japan

Condition
Condition Healthy adults
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is investigate the effects of test food intake for 12 weeks on metabolic syndrome related factor
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Visceral fat area, body fat percentage, HDL-cholesterol, triglyceride, fasting blood sugar, waist circumference, systolic blood pressure, diastolic blood pressure, LDL-cholesterol
Key secondary outcomes 1)Subcutaneous fat area, total fat area, weight
2)adiponectin, leptin, free fatty acids, Insulin, HOMA-R, HbA1c, Total cholesterol
3)Immunoglobulin, anti-paramylon antibody titer
4) questionnaire survey about physical condition, defecation behavior, eating behavior, exercise behavior

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 Institution is not considered as adjustment factor.
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 Intake test food thrice daily for 12 weeks.
Interventions/Control_2 Intake control food thrice daily for 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
20 years-old <=
Age-upper limit
65 years-old >
Gender Male and Female
Key inclusion criteria 1)Healthy Japanese women and men, between 20 and 64 years age when consent acquisition.
2)Body mass index of 24 to 30kg/m2
3)Waist circumference condition (>=85cm Male, >=90cm female)
4) Subjects who are no planned to change their lifestyle.
5) Individuals who don't have irregular or disturbed life style such as night shifts.
6)Subjects who have received enough explanation about this study and were able to understand that, then giving written informed consent.
Key exclusion criteria 1)At least one previous medical history of malignant tumor, heart failure or myocardial infraction
2) Currently under the treatment for either cardiac arrhythmia, hepatic disorder, renal disorder, cerebrovascular disorder, rheumatism, diabetes mellitus.
3) Subjects who have previous and/or current medical history of serious disease (e.g., heart, liver, kidney, digestive organ).
4)Subjects who excessive alcohol intake.
5)Subjects who are allergic to medicines and/or the test food related products.
6)Subjects who took part in another clinical study within 3 months prior to the start of the present study.
7)Subjects who routinely intake supplements such as euglena, chlorella, spirulina, beta-glucan and supplement that may decrease the visceral fat level, cholesterol and blood sugar level.
8) Subjects are taking warfarin and the investigator has determined that it is inappropriate for this study.
9)Females who are pregnant or lactating, and females who could become pregnant or lactating during test period.
10)Subjects with abnormal food habit or irregular life style such as shifts workers or late-night workers.
11) Subjects who suffer from severe anemia
12)Subjects having blood sample 400mL or more taken within 3 months prior to the start of the present study (e.g. donated blood).
13)Subjects have some designed infectious disease.
14) Subjects deemed unsuitable by the investigator.
Target sample size 40

Research contact person
Name of lead principal investigator
1st name Kazuhiko
Middle name
Last name Takano
Organization Medical Corporation Hokubukai Utsukushigaoka hospital
Division name Clinical Pharmacology Center
Zip code 004-0839
Address 61-1, Sinei, Kiyota-ku, Sapporo, Hokkaido, 004-0839, Japan
TEL 011-882-0111
Email takano@ughp-cpc.jp

Public contact
Name of contact person
1st name Machiko
Middle name
Last name Nishioka
Organization KOBELCO ECO-SOLUTIONS CO., LTD.
Division name Technical Develop Center
Zip code 651-2241
Address 1-1-4, Murotani, Nishi-ku, Kobe 651-2241, JAPAN
TEL 078-992-6957
Homepage URL
Email nishioka.machiko@kobelco.com

Sponsor
Institute Medical Corporation Hokubukai Utsukushigaoka hospital
Institute
Department

Funding Source
Organization KOBELCO ECO-SOLUTIONS 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 Institutional Review Board of Medical Corporation Hokubukai Utsukushigaoka Hospital
Address 61-1, Shinei, Kiyota-ku, Sapporo, 004-0839, Japan
Tel 011-882-0111
Email matsuda@ughp-cpc.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
2022 Year 01 Month 24 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
2021 Year 01 Month 21 Day
Date of IRB
Anticipated trial start date
2021 Year 01 Month 25 Day
Last follow-up date
2021 Year 05 Month 15 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 01 Month 24 Day
Last modified on
2021 Year 09 Month 30 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049168

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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