UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000032555
Receipt number R000037130
Scientific Title A clinical study to evaluate the anti-obesity effect of capsules containing noni fruit powder.
Date of disclosure of the study information 2019/08/31
Last modified on 2023/05/15 12:33:00

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Basic information

Public title

A clinical study to evaluate the anti-obesity effect of capsules containing noni fruit powder.

Acronym

A clinical study to evaluate the anti-obesity effect of capsules containing noni fruit powder.

Scientific Title

A clinical study to evaluate the anti-obesity effect of capsules containing noni fruit powder.

Scientific Title:Acronym

A clinical study to evaluate the anti-obesity effect of capsules containing noni fruit powder.

Region

Japan


Condition

Condition

Healthy subjects

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the anti-obesity effect of intake capsules containing noni fruit powder for 12 weeks.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

body weight, BMI

Key secondary outcomes

waist circumference, visceral fat area, body fat percentage, total fat area


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


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Food

Interventions/Control_1

Intake of capsules containing noni fruit powder for 12 weeks.

Interventions/Control_2

Intake of capsules non-containing noni fruit powder (placebo) 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

55 years-old >

Gender

Male and Female

Key inclusion criteria

The subject who meets all the conditions in a screening test
1) Subject whose age of 20 years or more and less than 55 years at the time of informed consent.
2) Subject whose BMI is 25 kg/m2 or more and less than 30 kg/m2.
3) Subject who is received sufficient explanation about purpose and content of this exam and have the capacity to consent and voluntarily write participation agreement in this examination voluntarily participate after understanding well.

Key exclusion criteria

1) Subject who has a mental disease such as depression, schizophrenia, epilepsy and bulimia nervosa.
2) Subject who has allergic disease, cardiovascular, respiratory, thyroid gland malfunction, diabetes, heart disease, heart disease, gout or sleep disorder.
3) Subject who takes regularly medicinal drugs or medicines having an effect on the weight.
4) Subject who has the possibility of developing allergic symptoms by the test food (noni allergy).
5) Subject who has a snacking habit that influence the evaluation of the effects of the test food.
6) Female subject who is pregnant or may be pregnant during the study.
7) Female subject who is in the lactation during the study.
8) Subject who took blood samples of 200 ml or more within 1 month, or 400 ml or more within 3 months prior to the start of the present study (e.g. donated blood).
9) Subject who participated in other clinical trials within the past 4 months or currently participating in other clinical trials or planning to participate in other clinical trials during the examination period.
10) Subject deemed unsuitable by the investigator.

Target sample size

120


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Masaya Morimoto

Organization

ASKA Pharmaceutical. Co., Ltd.

Division name

Healthcare Business Unit

Zip code


Address

2-5-1, Shibaura, Minato-ku, Tokyo

TEL

03-5484-8307

Email

morimoto-ms@aska-pharma.co.jp


Public contact

Name of contact person

1st name
Middle name
Last name Tomohiro Sugino

Organization

Soiken Inc.

Division name

R&D Division

Zip code


Address

Senri Life Science Center 13F, 1-4-2,Shinsenri-higashimachi,Toyonaka,Osaka

TEL

06-6871-8888

Homepage URL


Email

sugino@soiken.com


Sponsor or person

Institute

Soiken Inc.

Institute

Department

Personal name



Funding Source

Organization

ASKA Pharmaceutical. Co., Ltd.

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



Other administrative information

Date of disclosure of the study information

2019 Year 08 Month 31 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 03 Month 17 Day

Date of IRB

2018 Year 03 Month 17 Day

Anticipated trial start date

2018 Year 05 Month 13 Day

Last follow-up date

2018 Year 09 Month 08 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 05 Month 11 Day

Last modified on

2023 Year 05 Month 15 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037130


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name