UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033836 |
|---|---|
| Receipt number | R000038592 |
| Scientific Title | Effect of daily intake of the test food on serum lipid levels and body composition |
| Date of disclosure of the study information | 2019/04/01 |
| Last modified on | 2018/09/05 20:02:20 |
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Basic information
Public title
Effect of daily intake of the test food on serum lipid levels and body composition
Acronym
Effect of the test food intake on serum lipid levels and body composition
Scientific Title
Effect of daily intake of the test food on serum lipid levels and body composition
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Seiichiro Aoe |
Organization
Otsuma Women's University
Division name
Faculty of Home Economics Department Food Science
Zip code
Address
12 Sanban-cho,Chiyoda-ku,Tokyo
TEL
+81-3-5275-6048
s-aoe@otsuma.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Seiichiro Aoe |
Organization
Otsuma Women's University
Division name
Faculty of Home Economics Department Food Science
Zip code
Address
12 Sanban-cho, Chiyoda-ku, Tokyo 102-8357, Japan
TEL
+81-3-5275-6048
Homepage URL
s-aoe@otsuma.ac.jp
Sponsor or person
Institute
Seiichiro Aoe
Otsuma Women's University
Faculty of Home Economics
Department Food Science
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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 |
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
Terminated
Date of protocol fixation
| 2018 | Year | 08 | Month | 17 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038592
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