UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000037107
Receipt number R000042283
Scientific Title Study on evaluation of reduction effect of test supplement on body weight -a randomized, double blind, placebo controlled, parallel group comparison study-
Date of disclosure of the study information 2019/06/20
Last modified on 2020/06/12 09:09:16

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Basic information

Public title

Study on evaluation of reduction effect of test supplement on body weight -a randomized, double blind, placebo controlled, parallel group comparison study-

Acronym

Body weight reduction effect of test supplement

Scientific Title

Study on evaluation of reduction effect of test supplement on body weight -a randomized, double blind, placebo controlled, parallel group comparison study-

Scientific Title:Acronym

Body weight reduction effect of test supplement

Region

Japan


Condition

Condition

Healthy adult

Classification by specialty

Not applicable Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

This study aimed to assess the effect of test supplement on body weight

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Body weight

Key secondary outcomes

Abdominal visceral fat area, abdominal total fat area, abdominal subcutaneous fat area, BMI, body fat percentage, waist circumference, hip circumference, ratio of waist and hip circumferences, subgroup analysis (BMI, abdominal visceral fat area, sex, defecation frequency)


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

Institution is not considered as adjustment factor.

Blocking


Concealment

No need to know


Intervention

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

Intake of test supplement for 12 consecutive weeks

Interventions/Control_2

Intake of placebo for 12 consecutive 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

45 years-old <=

Age-upper limit

70 years-old >

Gender

Male and Female

Key inclusion criteria

1. Japanese male and female whose age is between 45 and 70 years old.
2. Subjects whose BMI is between 23 and 30.
3. Subjects who can understand the aim of this study and have the competency for giving consent.

Key exclusion criteria

1 Subjects who currently are dieting
2 Subjects who have some metal which the abdomen cannot remove
3 Subjects who have bolt in lumbar spine
4 Subjects who have stoma
5 Subjects who plan the examination with barium within one week before each examination day after screening test step 2
6 Subjects who are currently under medical treatment
7 Subjects who are currently under exercise and dietary treatment
8 Subject who have an allergy against trial supplement
9 Subjects who have current disease or history of drug and/or alcoholism
10 Subjects who have current treatment or history of mental disorder and/or sleep disorder
11 Subjects who are night shift or shift workers
12 Subjects with extremely irregular lifestyles such as food and sleep
13 Subjects who have an extreme unbalanced diet
14 Subjects who have serious disease or history
15 Subjects who use health foods, supplements and medicines that affect weight and lipid metabolism
16 Subjects who participated in other clinical trials within one month from the date of obtaining consent, or who plan to participate in other clinical trials during the trial period
17 Subjects who carried out blood collection, component blood donation more than 400 mL within 200 mL or 3 months within one month going back from the date of consent acquisition
18 Females who are known or suspected to be pregnant, breastfeeding or desire to become pregnant during the trial period.
19 Subjects who have a habit of taking a food containing a large amount of lactic acid bacteria for 3 days or more a week
20 Subjects who always use a laxative for defecation
21 Subjects who used probiotics, antibiotics
22 Subjects who have difficulty in keeping records on various questionnaires
23 Subjects who have difficulty in keeping records on various questionnaires
24 Subjects who are judged as unsuitable for the study by the investigator for other reason

Target sample size

100


Research contact person

Name of lead principal investigator

1st name Kei
Middle name
Last name Yui

Organization

FANCL Corporation

Division name

Research Institute, Health science research center

Zip code

2440806

Address

12-13, Kamishinano, Totsuka-ku, Yokohama, Kanagawa

TEL

0458203755

Email

ke-yui@fancl.co.jp


Public contact

Name of contact person

1st name Daisuke
Middle name
Last name Ochitani

Organization

HUMA R&D CORP

Division name

Clinical Development Division

Zip code

108-0014

Address

Round Cross Tamachi. 10th Fl., 5-31-19 Shiba,Minato-ku, Tokyo

TEL

03-3431-1260

Homepage URL


Email

ochitani@huma-rd.co.jp


Sponsor or person

Institute

HUMA R&D CORP

Institute

Department

Personal name



Funding Source

Organization

FANCL Corporation

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Ethics Committees of Nihonbashi Egawa Clinic

Address

Kotobuki Building, 1-1-3, Yaesu, Chuo-ku, Tokyo

Tel

03-5204-0311

Email

jim@medipharma.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

医療法人共創会 AMC西梅田クリニック
医療法人あけぼの会 あけぼのGMクリニック


Other administrative information

Date of disclosure of the study information

2019 Year 06 Month 20 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

100

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 06 Month 14 Day

Date of IRB

2019 Year 06 Month 17 Day

Anticipated trial start date

2019 Year 07 Month 01 Day

Last follow-up date

2019 Year 11 Month 28 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 06 Month 19 Day

Last modified on

2020 Year 06 Month 12 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042283


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name