UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000036926
Receipt No. 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 (Ver. 5)

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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
Email 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
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)

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042077