UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047577 |
|---|---|
| Receipt number | R000054254 |
| Scientific Title | Effect of daily intake of the test food on serum lipid levels and visceral fat accumulation |
| Date of disclosure of the study information | 2022/04/26 |
| Last modified on | 2025/11/02 16:03:05 |
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Basic information
Public title
Effect of daily intake of the test food on serum lipid levels and visceral fat accumulation
Acronym
Effect of the test food intake on serum lipid levels and visceral fat accumulation
Scientific Title
Effect of daily intake of the test food on serum lipid levels and visceral fat accumulation
Scientific Title:Acronym
Effect of the test food intake on serum lipid levels and visceral fat accumulation
Region
| Japan |
Condition
Condition
Age: between 20 and 59 years old , Body mass index (BMI): above 25 kg/m2 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 visceral fat accumulation
Basic objectives2
Others
Basic objectives -Others
Timing: Pre-health check/after 12w 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 / 12W
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Visceral fat area
Key secondary outcomes
Total fat area, subcutaneous fat area
Waist circumstance, body weight, Body mass index (BMI), Body composition
Serum lipids (total cholesterol, LDL-cholesterol, Triglyceride), leptin, adiponectin
Fecal microbiota analysis
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 microcrystalline cellulose.
Six cookies / day at any meal
Feeding period; 12 weeks
Interventions/Control_2
Powdered kelp: One cookie contains 1g of powdered kelp.
Alginate contains 0.6g / cookie, Iodine contains 0.07mg / cookie (0.42mg / day; less than 3mg / day of tolerable upper intake level).
Six cookies / day at any meal
Feeding period; 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
| 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.
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 .
(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
44
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
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
Daiwa Building, 3-3-10 Hongoku-cho Nihonbashi, Cyuou-ku, Tokyo 103-0021, Japan
Tel
+81-3-6225-9005
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
| 2022 | Year | 04 | Month | 26 | Day |
Related information
URL releasing protocol
https://doi.org/10.1002/fsn3.70298
Publication of results
Published
Result
URL related to results and publications
https://doi.org/10.1002/fsn3.70298
Number of participants that the trial has enrolled
41
Results
Body fat content and percentage were significantly decreased in the male kombu group compared to the placebo group. Systolic blood pressure was significantly lower in males and females in the kombu group compared with the placebo group. Significant increases in the abundances of genus Faecalibacterium, Bacteroides, Alistipes, and Agathobacter were observed in the kombu group compared to the placebo group.
Results date posted
| 2022 | Year | 10 | Month | 31 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2023 | Year | 06 | Month | 01 | Day |
Baseline Characteristics
The participants completed the trial. The two groups were similar in age, height, body weight, and body mass index
Participant flow
Forty-four subjects were eligible for trial participation. Three subjects dropped out during the study: two subjects in the placebo group and one subject in the kombu group withdrew for reasons unrelated to the study.
Adverse events
During the study, one subject experienced loose stools due to the test food, and the subject declined to continue the study. The remaining subjects were included in data analysis. During the study period, no adverse events (e.g., gastrointestinal problems) were found to be related to the consumption of kombu cookies, except for one subject who was excluded.
Outcome measures
The primary objective of this study was to evaluate the effect of boiled kombu powder on reducing body fat and the associated changes in gut microbiota in subjects with high BMI.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2022 | Year | 02 | Month | 07 | Day |
Date of IRB
| 2022 | Year | 02 | Month | 18 | Day |
Anticipated trial start date
| 2022 | Year | 04 | Month | 26 | Day |
Last follow-up date
| 2022 | Year | 08 | Month | 30 | Day |
Date of closure to data entry
| 2022 | Year | 09 | Month | 14 | Day |
Date trial data considered complete
| 2022 | Year | 09 | Month | 14 | Day |
Date analysis concluded
| 2023 | Year | 02 | Month | 28 | Day |
Other
Other related information
Management information
Registered date
| 2022 | Year | 04 | Month | 24 | Day |
Last modified on
| 2025 | Year | 11 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054254
