UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of daily intake of the test food on serum lipid levels and body composition
Title of the study (Brief title)	Effect of the test food intake on serum lipid levels and body composition
Region	Japan

Condition
Condition	Body mass index (BMI): above 25 and less than 30 adult men and women
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To estimate the effect of the test food on serum lipid levels and body composition
Basic objectives2	Others
Basic objectives -Others	Timing: Pre-health check/after 8w feeding Inquiry (Inquiry, Blood pressure, pulsation, Weight, Fat %) Analysis of urine (Urinary protein, sugar, urobilinogen, ALB, AST(GOT), ALT(GPT), LDH, T-Bil, ALP, gamma-GTP, CPK, Ca, Fe, Mg, T-cho, LDL-C, HDL-C, TG, GLC(GLU), HbA1c(NGSP) General blood check (leucocyte, erythrocyte, hemoglobin, Hematocrit, blood platelet) Thyroid function tests : FT3, FT4, TSH # of blood sampling: 1 blood sample/ period Timing of blood sampling: 0W/ 8W
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	Visceral fat area
Key secondary outcomes	Serum lipids (total cholesterol, LDL-cholesterol, Triglyceride), Body weight, Body mass index (BMI), Body composition

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification	YES
Dynamic allocation	YES
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	No need to know

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Non powdered kelp contains maltitol and crystalline cellulose. Ten tablets x 3times / day during meal Feeding period; 8 weeks
Interventions/Control_2	Powdered kelp: One tablet contains 196.7mg of powdered kelp. Powdered kelp 0.11g / tablet as dietary fiber. Key alginate contains 101mg / tablet, Iodine contains 0.0387mg / tablet (1.16mg / day; less than 3mg / day of tolerable upper intake level). Ten tablets x 3times / day during meal Feeding period: 8 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	Not applicable
Gender	Male and Female
Key inclusion criteria	Basically healthy person Body mass index (BMI) is above 25 and less than 30.
Key exclusion criteria	(1) The person with severe disease in the liver, kidney, heart, lung, digestive organs, blood, endocrine, and urology. (2) The person who is undergoing therapeutic treatment or take a drug at the time of informed consent agreement. (3) Person having food or drug allergy, hypersensitivity, or those medical history. (4) Person who cannot eat kelp (5) Person who eats FOSHU, Foods with Function Claims, Supplement, So-called health food rich in dietary fiber daily. (6) Person who is controlled or limited iodine intake. (7) Person who drinks excessive alcohol (above 30g/day as alcohol). (8) Person with abnormal food habit or irregular life style such as shifts workers or late-night workers. (9) Person participating in an examination to apply an intake of other food and the examination using the drug, person with the intention of the participation within 4 weeks or after informed consent agreement of present test. (10) Men who carried out the whole blood donation of 400ml from start of this test three months ago. (11) Women who carried out the whole blood donation of 400ml from start of this test four months ago. (12) Person who judged an examination responsibility doctor to be inappropriate as a subject
Target sample size	30

Research contact person
Name of lead principal investigator	Seiichiro Aoe
Organization	Otsuma Women's University
Division name	Faculty of Home Economics Department Food Science
Address	12 Sanban-cho,Chiyoda-ku,Tokyo
TEL	+81-3-5275-6048
Email	s-aoe@otsuma.ac.jp

Public contact
Name of contact person	Seiichiro Aoe
Organization	Otsuma Women's University
Division name	Faculty of Home Economics Department Food Science
Address	12 Sanban-cho, Chiyoda-ku, Tokyo 102-8357, Japan
TEL	+81-3-5275-6048
Homepage URL
Email	s-aoe@otsuma.ac.jp

Sponsor
Institute	Seiichiro Aoe Otsuma Women's University Faculty of Home Economics Department Food Science
Institute
Department

Funding Source
Organization	Hokkaido Federation of Fisheries Associations
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor	Maruyanagi Foods Inc.
Name of secondary funｄer(s)

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	大妻女子大学（東京都）/Otsuma Women’s university (Tokyo) CPCC株式会社/CPCC Company Limited

Other administrative information
Date of disclosure of the study information	2019 Year 04 Month 01 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2018 Year 08 Month 17 Day
Anticipated trial start date	2018 Year 08 Month 23 Day
Last follow-up date
Date of closure to data entry	2018 Year 09 Month 06 Day
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2018 Year 08 Month 21 Day
Last modified on	2018 Year 09 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038592