UMIN-CTR Clinical Trial

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://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049168