UMIN-CTR Clinical Trial

Public title

A pilot study about the efficacy of Angelica keiskei for the morbid obese patients screened with their own adipose derived stem cell.

Acronym

A pilot study about the efficacy of the supplements based on ADSC screening.

Scientific Title

A pilot study about the efficacy of Angelica keiskei for the morbid obese patients screened with their own adipose derived stem cell.

Scientific Title:Acronym

A pilot study about the efficacy of the supplements based on ADSC screening.

Region

Japan

Condition

Morbid obesity

Classification by specialty

Endocrinology and Metabolism

Gastrointestinal surgery

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

We verify that the supplements have the effect of increasing blood adiponectin level in vivo, which effect is confirmed in vitro.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Phase I,II

Primary outcomes

Adiponectin

Key secondary outcomes

Blood lipids
Nutritional indicators
Body composition

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -but assessor(s) are blinded

Control

No treatment

Stratification

YES

Dynamic allocation

YES

Institution consideration

Blocking

Concealment

No. of arms

3

Purpose of intervention

Treatment

Type of intervention

Food

Interventions/Control_1

We collect the surplus adipose cell during sleeve gastorectomy in patients with morbid obesity.
After the culture, Angelica keiskei is added to adipose-derived stem cell.
Adiponectin increasing effect is observed:1
Adiponectin increasing effect is not observed:2
*****************************************
The case of 1: Randomized and divided into 2 groups.
Effective and supplement intake group:5 people
Subjects take two pouch of Angelica keiskei supplements per a day for 6 month.
Each evaluations are performed every two month.

Interventions/Control_2

Same as interventions 1
******************************************
The result of interventions 2, subjects who are assigned to non-intervention belongs to the group below.
Effective and non-intervention group:5 people
Each evaluations are performed every two month.
No intakes of supplements.

Interventions/Control_3

Same as interventions 1
******************************************
Subjects of 2
Not effective and non-intervention group:5 people
Each evaluations are performed every two month.
No intakes of supplements.

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

Not applicable

Gender

Male and Female

Key inclusion criteria

1) Morbid Obese patients who were performed Sleeve gastrectomy.
2) Patients expected over 3 month-survival from the first day of this study.
3) Patients who are obtained with the prior written consent.

Key exclusion criteria

1) Patients with food allergy
2) Patients less than 20 years old.
3) Patients judged to be inappropriate for this study from the doctor in charge.

Target sample size

15

Name of lead principal investigator

1st name
Middle name
Last name	Kazuhisa Maeda

Organization

Osaka University Graduate School of Medicine

Division name

Department of Complementary and Alternative Medicine

Zip code

Address

2-2 Yamadaoka, Suita, Osaka, Japan

TEL

06-6879-3498

Email

kaz@cam.med.osaka-u.ac.jp

Name of contact person

1st name
Middle name
Last name	Asuka Yasueda

Organization

Osaka University Graduate School of Medicine

Division name

Department of Complementary and Alternative Medicine

Zip code

Address

2-2 Yamadaoka, Suita, Osaka, Japan

TEL

06-6879-3498

Homepage URL

Email

a-yasueda@cam.med.osaka-u.ac.jp

Institute

Osaka University Graduate School of Medicine

Institute

Department

Personal name

Organization

Takara Bio INC.

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

大阪大学医学部付属病院

Date of disclosure of the study information

2014

Year

05

Month

07

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

2014

Year

05

Month

01

Day

Date of IRB

Anticipated trial start date

2014

Year

05

Month

02

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2014

Year

05

Month

02

Day

Last modified on

2017

Year

11

Month

06

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016184