UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036926 |
|---|---|
| Receipt number | R000042077 |
| Scientific Title | Effect of daily intake of the test food on serum lipid levels and body composition |
| Date of disclosure of the study information | 2019/06/03 |
| Last modified on | 2020/01/13 12:12:01 |
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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
Age: between 20 and 59 years old , 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 109.3mg / tablet, Iodine contains 0.0343mg / tablet (1.03mg / 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
| 59 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Basically healthy person
Age is between 20 and 59 years old.
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
50
Research contact person
Name of lead principal investigator
| 1st name | Seiichiro |
| Middle name | |
| Last name | Aoe |
Organization
Otsuma Women's University
Division name
Faculty of Home Economics Department Food Science
Zip code
102-8357
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 | Seiichiro |
| Middle name | |
| Last name | Aoe |
Organization
Otsuma Women's University
Division name
Faculty of Home Economics Department Food Science
Zip code
102-8357
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
Institutional Review Board of Chiyoda Paramedical Care Clinic
Address
2F Chushin Building, 3-3-5 Uchikanda Chiyoda-ku, Tokyo 101-0047, Japan
Tel
+81-3-5297-5548
IRB@cpcc.co.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
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 | 06 | Month | 03 | 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
50
Results
Kombu supplementation was shown to reduce body fat ratio and body weight in obese men. It was found that kombu supplementation decreased serum LDL-cholesterol levels in obese men and women. In addition, thyroid hormone levels were not influenced by daily intake of 1 mg iodine in kombu supplement.
Results date posted
| 2020 | Year | 01 | Month | 13 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2020 | Year | 03 | Month | 28 | Day |
Baseline Characteristics
The study was conducted in 50 healthy men and women with informed consent from 20 to 59 years old and BMI of 25 kg / m2 to less than 30 kg / m2 after approval by the Ethics Committee.
Participant flow
The assignment was stratified by the visceral fat area, BMI, age, gender, and LDL-cholesterol concentrations at the screening, and 50 subjects were randomly assigned to 25 groups each of which was a placebo group and a kombu supplement group.
Adverse events
One subject was dropout by personal reason and other subjects was omitted by the exclusion criteria. Twenty -four subjects per group were included for final analysis. One subject with allergic symptoms was observed, but it was not a kombu allergy.
Outcome measures
After eight weeks, a body composition and a serum chemistry levels were measured. Body composition was measured for visceral fat area, BMI, and body fat ratio, and blood chemistry was for total, LDL, HDL-cholesterol, triglyceride, and thyroid hormone (TSH, F3, F4) concentrations. Unpaired t-test or Welch's test was performed for comparison between the two groups.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2019 | Year | 05 | Month | 16 | Day |
Date of IRB
| 2019 | Year | 04 | Month | 19 | Day |
Anticipated trial start date
| 2019 | Year | 05 | Month | 20 | Day |
Last follow-up date
| 2019 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
| 2019 | Year | 10 | Month | 30 | Day |
Date trial data considered complete
| 2019 | Year | 12 | Month | 28 | Day |
Date analysis concluded
| 2019 | Year | 12 | Month | 28 | Day |
Other
Other related information
Management information
Registered date
| 2019 | Year | 06 | Month | 02 | Day |
Last modified on
| 2020 | Year | 01 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042077
