UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000038725
Receipt number R000044131
Scientific Title A randomized, double-blind, placebo-controlled, parallel-group study on the effect of food containing fucose on obesity and constipation.
Date of disclosure of the study information 2019/12/02
Last modified on 2021/04/09 17:39:19

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Basic information

Public title

A randomized, double-blind, placebo-controlled, parallel-group study on the effect of food containing fucose on obesity and constipation.

Acronym

Study on the effect of food containing fucose on obesity and constipation.

Scientific Title

A randomized, double-blind, placebo-controlled, parallel-group study on the effect of food containing fucose on obesity and constipation.

Scientific Title:Acronym

Study on the effect of food containing fucose on obesity and constipation.

Region

Japan


Condition

Condition

Healthy and overweight adult subjects between 23 or more and less than 30 in body mass index (BMI)

Classification by specialty

Not applicable

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To examine the effect of food containing fucose on obesity and constipation.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2


Developmental phase

Not applicable


Assessment

Primary outcomes

Visceral fat area
*Assess the fat area by X-ray CT

Key secondary outcomes

1. Subcutaneous fat area
2. Total fat area
3. Visceral fat area
4. Subcutaneous fat area
5. Total fat area
6. Waist and Hip circumference
7. Body weight
8. Defecation frequency
9. Bristol stool scale

*1-2 Assess these by X-ray CT
*3-5 Assess these by Bioelectrical impedance 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


Dynamic allocation


Institution consideration


Blocking

YES

Concealment

Numbered container method


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Food

Interventions/Control_1

Ingestion of supplement containing fucose for 20 weeks.

Interventions/Control_2

Ingestion of placebo without fucose for 20 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

65 years-old >

Gender

Male and Female

Key inclusion criteria

1. Healthy males and females aged 20 to 64 years old
2. Subjects who are between 23 kg/m2 or more and less than 30 kg/m2 in BMI
3. Subjects with subjective symptoms of chronic constipation
4. Subjects who can make self-judgment and are voluntarily giving written informed consent

Key exclusion criteria

1. Subjects who use medications affecting obesity and constipation
2. Subjects who cannot stop using supplements and/or functional foods affecting obesity and constipation
3. Subjects who are under treatment or have a history of disease e.g., serious liver disease, heart disease, respiratory insufficiency, endocrine disorder, metabolic diseases or food allergy
4. Subjects who have under treatment or a history of drug addiction and/or alcoholism
5. Subjects who have implanted metal in the abdominal area, as detected by computerized tomography
6. Subjects who have a pacemaker or an implantable cardioverter defibrillator (ICD)
7. Subjects who have been diagnosed as familial hyperlipidemia
8. Subjects who has food allergy
9. Subjects who are participating or planning to participate in other clinical studies to examine effects of food, medicine or cosmetics
10. Subjects who are planning to become pregnant during the study or are pregnant or lactating
11. Subjects who are judged as unsuitable for the study by the investigator for other reasons

Target sample size

80


Research contact person

Name of lead principal investigator

1st name Satoru
Middle name
Last name Suzuki

Organization

Shinagawa Season Terrace Health Care Clinic

Division name

General Manager of Medical Examination Department

Zip code

108-0075

Address

1-2-70, Konan, Minato-ku, Tokyo The 5th floor of Shinagawa season terrace

TEL

03-3452-3381

Email

satoru_suzuki@sempos.or.jp


Public contact

Name of contact person

1st name Eiji
Middle name
Last name Yoshikawa

Organization

KSO Corporation

Division name

Sales department

Zip code

105-0023

Address

1-9-7, Shibaura, Minato-ku, Tokyo The 7th floor of Shibaura omodaka building

TEL

03-3452-7733

Homepage URL


Email

yoshikawa@kso.co.jp


Sponsor or person

Institute

KSO Corporation

Institute

Department

Personal name



Funding Source

Organization

Japan Science and Technology Agency

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)

Yaizu Suisankagaku Industry Co., Ltd.


IRB Contact (For public release)

Organization

Shinagawa Season Terrace Health Care Clinic

Address

1-2-70, Konan, Minato-ku, Tokyo The 5th floor of Shinagawa season terrace

Tel

03-3452-3381

Email

tomohiro_kogo@sempos.or.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



Other administrative information

Date of disclosure of the study information

2019 Year 12 Month 02 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

Completed

Date of protocol fixation

2019 Year 11 Month 20 Day

Date of IRB

2019 Year 12 Month 14 Day

Anticipated trial start date

2020 Year 01 Month 06 Day

Last follow-up date

2020 Year 07 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2019 Year 11 Month 29 Day

Last modified on

2021 Year 04 Month 09 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044131


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name