UMIN-CTR Clinical Trial

Public title

Effect of supplement on VFA reduction. - A randomized, double-blind, placebo-controlled, parallel-group clinical trial -

Acronym

Effect of supplement on VFA reduction.

Scientific Title

Effect of supplement on VFA reduction. - A randomized, double-blind, placebo-controlled, parallel-group clinical trial -

Scientific Title:Acronym

Effect of supplement on VFA reduction.

Region

Japan

Condition

none

Classification by specialty

Not applicable

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

This study aims to evaluate the effect of ingestion of supplement on visceral fat area.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Visceral Fat Area(VFA)

Key secondary outcomes

Body Weight, BMI, Subcutaneous fat area(SFA), Total fat area(TFA), Stool frequency, Bristol stool from scale(BSFS)

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

Ingestion of supplement for twenty-four weeks.

Interventions/Control_2

Ingestion of placebo for twenty-four 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

Age-lower limit

50

years-old

<=

Age-upper limit

70

years-old

>

Gender

Male and Female

Key inclusion criteria

1) Japanese males and females aged 50 to 70 years.
2)Subjects who are evaluating body mass index 25 to 30.
3) Subjects who are feeling disorder of stool form including chronic hard stool or loose stool.
4) Subjects who received a sufficient explanation about the purpose and content of this study and have a consent ability and volunteered to participate in the understanding and can agree to this study participation in writing.

Key exclusion criteria

1) Subjects who use medicine that may influence a bowel movement.
2) Subjects who take health food or dietary supplement that may influence a bowel movement.
3) Subjects who take general food including Bifidbacterium that continue more than three times a week and more than half year.
4) Subjects who take medicine, Kampo preparation or dietary supplement affecting weight reduction.
5) Subjects who have colonic disease within 10 years, but these persons except who polyp or infectious colitis.
6) Subjects who take medical treatment for obesity-related disease that is glucose intolerance, dyslipidemia, hypertension, hyperuricemia, gout, coronary artery disease, cerebral infarction, fatty liver, menstrual abnormality, sleep apnea syndrome･obesity hypoventilation syndrome, orthopedic disease, obesity-related renal disease.
7) Subjects who have severe disorders in liver function or kidney function.
8) Subjects who have history of gastrointestine surgery that is gastrectomy, gastrointestinal suture, enterectomy, etc.
9) Subjects who have allergy to medicine, shrimp, crab, milk or egg.
10) Subjects who can't discontinue dietary supplements for test period.
11) Subjects who are planned to participate in other clinical study.
12) Female with pregnancies, lactating or planning to become pregnant during the study.
13) Subjects whom metal is implanted in a CT scanning part by operation treatment.
14) Subjects whom heart pacemaker or implantable cardiac defibrillator is implanted in own body.
15) Subjects who have extreme constipation or diarrhea.
16) Subjects who are judged as unsuitable for the study by the investigator for other reason.

Target sample size

170

Name of lead principal investigator

1st name
Middle name
Last name	Satoru Suzuki

Organization

Shinagawa Season Terrace Health Care Clinic

Division name

Medical examination and treatment management family chief director

Zip code

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

Name of contact person

1st name
Middle name
Last name	Eiji Yoshikawa

Organization

KSO Corporation

Division name

Sales department

Zip code

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

Institute

KSO Corporation

Institute

Department

Personal name

Organization

FANCL Corporation

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

品川シーズンテラス健診クリニック（東京都）

Date of disclosure of the study information

2018

Year

06

Month

30

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Completed

Date of protocol fixation

2018

Year

05

Month

21

Day

Date of IRB

2018

Year

05

Month

23

Day

Anticipated trial start date

2018

Year

06

Month

30

Day

Last follow-up date

2018

Year

12

Month

19

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2018

Year

05

Month

28

Day

Last modified on

2019

Year

05

Month

27

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037335