UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000034521
Receipt number R000039363
Scientific Title A study to evaluate the effects of foods containing plant-derived ingredients on the reduction of body fat - Randomized placebo-controlled double-blind parallel group comparison study-
Date of disclosure of the study information 2020/05/17
Last modified on 2019/10/17 09:41:52

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Basic information

Public title

A study to evaluate the effects of foods containing plant-derived ingredients on the reduction of body fat
- Randomized placebo-controlled double-blind parallel group comparison study-

Acronym

A study to evaluate the effects of foods containing plant-derived ingredients on the reduction of body fat

Scientific Title

A study to evaluate the effects of foods containing plant-derived ingredients on the reduction of body fat
- Randomized placebo-controlled double-blind parallel group comparison study-

Scientific Title:Acronym

A study to evaluate the effects of foods containing plant-derived ingredients on the reduction of body fat

Region

Japan


Condition

Condition

None

Classification by specialty

Not applicable Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate for reduction of body fat mass including visceral fat and for safety when supplementation with food containing ingredients of plant origin for 12 weeks for healthy adult men and women with BMI of 23.0 or more and less than 30.0 kg/m2

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Abdominal visceral fat area, body fat mass

Key secondary outcomes

Abdominal subcutaneous fat area, abdominal total fat area, waist circumference, hip circumference, W/H ratio, body weight, BMI, total cholesterol, HDL-cholesterol, LDL-cholesterol, triglyceride, blood pressures (systolic and diastolic), fasting blood glucose, insulin, HbA1c


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

NO

Institution consideration


Blocking

NO

Concealment

Central registration


Intervention

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

Take two capsules (520 mg) of the test food orally at dinner for 12 weeks

Interventions/Control_2

Take two capsules (520 mg) of the placebo food orally at dinner 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



Eligibility

Age-lower limit

20 years-old <=

Age-upper limit

65 years-old >

Gender

Male and Female

Key inclusion criteria

1) Japanese males and females aged of 20-64 years.
2) Subjects whose BMI values are 23.0 or more and less than 30.0.
3) Subjects who can visit the hospital/clinic on the scheduled visit date
4) Subjects who agreed in writing prior to the start of the trial with sufficient understanding of the purpose and contents of this study

Key exclusion criteria

1) Subjects who are under treatment or have a history of serious liver damage/disease, kidney disease, heart disease, lung disease, gastrointestinal disease (including gastrectomy), other severe disorders, or diabetes
2) Subjects who are under treatment (Excluding transient treatment such as common cold)
3) Subjects who cannot maintain their own life-style
4) Subjects who plan to travel overseas or have a long business trip during this study period
5) Subjects who are shift workers or graveyard shift workers
6) Subjects who use oral medication or supplements which may affect this study
7) Subjects drink alcohol over 1,000mL in terms of beer (= 40 mL of pure alcohol) per day
8) Subjects smoke over average 20 cigarettes per day
9) Subjects who are pregnant, lactation, or planning to become pregnant
10) Subjects who are sensitive to test product or other foods, and medical products.
11) Subjects who cannot take the test food as instructed
12) Subjects who donated blood component or more than 200 mL of whole blood from the last one month just before the start of the study
13) Subjects who have experienced sickness due to blood collection
14) Subjects in constipation (frequency of defecation twice or less a week, feces is hard, difficulty of defecation, feeling of remaining feces)
15) Subjects who participated in other clinical studies in the past 3 months
16) Subjects who have some metal inside the body
17) Subjects judged as unsuitable for this study by the principal investigator

Target sample size

180


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Iwao Funahashi

Organization

KANEKA CORPORATION

Division name

Pharma & Supplemental Nutrition Solutions Vehicle

Zip code


Address

1-12-32, Akasaka, Minato-ku, Tokyo, Japan

TEL

050-3133-6397

Email

Iwao.Funahashi@kaneka.co.jp


Public contact

Name of contact person

1st name
Middle name
Last name Toyotada Ashino

Organization

New drug research center, Inc.

Division name

Clinical Research Dept.

Zip code


Address

452-1Toiso,Eniwa-shi,Hokkaido, Japan

TEL

0123-34-0412

Homepage URL


Email

t-ashino@ndrcenter.co.jp


Sponsor or person

Institute

New drug research center, Inc.

Institute

Department

Personal name



Funding Source

Organization

KANEKA CORPORATION

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



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

福原医院(北海道)


Other administrative information

Date of disclosure of the study information

2020 Year 05 Month 17 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

2018 Year 10 Month 16 Day

Date of IRB

2018 Year 10 Month 16 Day

Anticipated trial start date

2019 Year 01 Month 04 Day

Last follow-up date

2019 Year 05 Month 18 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2018 Year 10 Month 16 Day

Last modified on

2019 Year 10 Month 17 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039363


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name