UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043114 |
|---|---|
| Receipt number | 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 18:07:38 |
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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
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
nishioka.machiko@kobelco.com
Sponsor or person
Institute
Medical Corporation Hokubukai Utsukushigaoka hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049168
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