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

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 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

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042077


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name