UMIN-ICDS Clinical Trial

Public title

Visceral fat reduction effect verification test by ingestion of plant extracts
-Placebo-controlled, randomized, double-blind, parallel-group comparison study-

Acronym

Verification test of the reduction effect on visceral fat by ingestion of plant extracts

Scientific Title

Visceral fat reduction effect verification test by ingestion of plant extracts
-Placebo-controlled, randomized, double-blind, parallel-group comparison study-

Scientific Title:Acronym

Verification test of the reduction effect on visceral fat by ingestion of plant extracts

Region

Japan

Condition

Healthy adults

Classification by specialty

Not applicable

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To examine the effect of continuous consumption of food containing plant extract for 12 weeks on abdominal visceral fat area.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

The measured value of abdominal visceral fat area at 12 weeks after ingestion

Key secondary outcomes

1) The measured value of abdominal visceral fat area at 8 weeks after ingestion
2) The amount of change in abdominal visceral fat area (8, 12 weeks after ingestion)
3) The measured value and the amount of change in abdominal subcutaneous fat area (8, 12 weeks after ingestion)
4) The measured value and the amount of change in total abdominal fat area (8, 12 weeks after ingestion)
5) The measured value and the amount of change in body fat percentage (4, 8, 12 weeks after ingestion)
6) The measured value and the amount of change in muscle mass (4, 8, 12 weeks after ingestion)
7) The measured value and the amount of change in body weight and/or body mass index (BMI) (4, 8, 12 weeks after ingestion)
8) The measured value and the amount of change in waist circumference (4, 8, 12 weeks after ingestion)
9) The measured value and the amount of change in hip circumference (4, 8, 12 weeks after ingestion)
10)The measured value and the amount of change in thigh circumference (4, 8, 12 weeks after ingestion)
11)The measured value and the amount of change in upper arm circumference (4, 8, 12 weeks after ingestion)
12)The measured value and the amount of change in the questionnaire on effectiveness (4, 8, 12 weeks after ingestion)

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

YES

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

Ingestion of test food for 12 weeks

Interventions/Control_2

Ingestion of placebo food for 12 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

20

years-old

<=

Age-upper limit

65

years-old

>

Gender

Male and Female

Key inclusion criteria

(1) Healthy subjects aged of 20-64 years
(2) Subjects with BMI >=25 and < 30 in primary screening test
(3) Subjects who have received sufficient explanation of the purpose and content of the study, have the ability to consent, voluntarily applied to participate in the study based on good understanding, and have agreed to participate in the study in writing.

Key exclusion criteria

(1) Subjects who take medicines regularly
(2) Subjects who have a current history of serious liver disease, kidney disease, gastrointestinal disease, heart disease, respiratory disease, endocrine disease, thyroid disease, adrenal gland disease, or other metabolic disease (excluding transient treatment such as colds)
(3) Subjects who have a digestive disease that affects digestion and absorption, or a history of surgery (excluding appendicitis)
(4) Subjects who have a history or current medical history of drug dependence or alcoholism
(5) Subjects who have been diagnosed with familial hyperlipidemia
(6) Subjects who are diagnosed with chronic constipation
(7) Subjects who are unable to stop taking health foods and supplements (including foods for specified health uses and foods with functional claims) that may affect this study
(8) Subjects who have a habit of drinking excessively (drinking more than 20 g of pure alcohol equivalent per day, at least 4 days a week)
(9) Subjects who have a habit of smoking excessively (smokers of 21 cigarettes or more per day)
(10) Subjects who are wearing a medical device necessary for life support, such as a cardiac pacemaker, implantable cardioverter defibrillator, or biological information monitor
(11) Subjects who have a contagious disease or an injury to the palms or the soles of the feet
(12) Subjects who have metal in the CT scan measurement site due to surgery, etc.
(13) Subjects who are claustrophobic
(14) Subjects who have reported that they are allergic to the ingredient in test foods
(15) Subjects who have extremely irregular eating habits, shift workers (excluding daytime shift work), or late-night workers

Target sample size

90

Name of lead principal investigator

1st name	Daisuke
Middle name
Last name	Tsuge

Organization

Shinagawa Season Terrace Health Care Clinic

Division name

Doctor

Zip code

108-0075

Address

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

TEL

03-3452-3382

Email

shibaura@sempos.or.jp

Name of contact person

1st name	Masanori
Middle name
Last name	Numazu

Organization

KSO Corporation

Division name

Clinical Trial Management department

Zip code

105-0023

Address

1-9-7 Shibaura, Minato-ku, Tokyo

TEL

03-3452-7733

Homepage URL

Email

eigyou27@kso.co.jp

Institute

KSO Corporation

Institute

Department

Personal name

Organization

Morishita Jintan Co., Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Organization

Ethical Committee of Kobuna Orthopedics Clinic

Address

5-656-17 Joto-machi, Maebashi-shi, Gumma

Tel

027-212-5608

Email

sagawa@mc-connect.co.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2024

Year

02

Month

22

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

Preinitiation

Date of protocol fixation

2023

Year

12

Month

13

Day

Date of IRB

2023

Year

12

Month

21

Day

Anticipated trial start date

2024

Year

02

Month

23

Day

Last follow-up date

2024

Year

07

Month

14

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

(Exclusion criteria continued)
(16) Subjects who may have a significant change in exercise habits, those who regularly exercise strenuously, and those who are on a diet during this study
(17) Subjects who plan to go abroad, a long-term business trip or trip in Japan (more than 10 days per month), or a job transfer during this study
(18) Subjects who have been judged as ineligible to participate by the principal investigator by the screening test
(19) Subjects who are pregnant, lactating, or planning to become pregnant during this study
(20) Subjects who are planning to participate and/or had participated in other clinical studies within the last one month of informed consent
(21) Subjects who are judged as ineligible to participate in this study by the principal investigator

Registered date

2024

Year

02

Month

21

Day

Last modified on

2024

Year

02

Month

19

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000061181