UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000021826
Receipt number R000025163
Scientific Title Evaluation of effectiveness of globin digest in obese children (the approved number: 2394)
Date of disclosure of the study information 2016/04/07
Last modified on 2016/04/18 15:40:17

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Basic information

Public title

Evaluation of effectiveness of globin digest in obese children (the approved number: 2394)

Acronym

Globin digest study

Scientific Title

Evaluation of effectiveness of globin digest in obese children (the approved number: 2394)

Scientific Title:Acronym

Globin digest study

Region

Japan


Condition

Condition

Obesity

Classification by specialty

Pediatrics

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

This study aimed to evaluate the effectiveness and safety of a globin digest (GD) functional beverage for the treatment of childhood obesity as a randomized, double-blind, placebo-controlled trial.

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2


Developmental phase

Not applicable


Assessment

Primary outcomes

Reduction of body weight, BMI percentile and percentage overweight and the improvement of laboratory blood data 4, 8, 12, 16, 20 weeks after globin digest beverage intake

Key secondary outcomes

Adverse events


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

YES

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

Central registration


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Food

Interventions/Control_1

Children under 12 years were given 25 mL of placebo or GD beverage within 1h of dinner daily for 3 months; children 12 to 18 years old were given 50 mL of placebo or GD beverage within 1h of dinner daily for 3 months.

Interventions/Control_2

Placebo group were given placebo beverage with a similar taste and appearance in a same manner as well as GD beverage.

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

6 years-old <=

Age-upper limit

18 years-old >

Gender

Male and Female

Key inclusion criteria

Percentage overweight is 20% or more than 20% and their body fat percentage (BFP) is greater than or equal to 25% in boys, greater than or equal to 30% in girls (<11 years) or greater than or equal to 35% in girls (>11 years)

Key exclusion criteria

(1) non-obese children
(2) Chronic intestinal diseases associated with absorption or digestion failure
(3) Severe liver disorder
(4) Kidney disease, other known severe underlying disease or past history of severe illness
(5) Females who are pregnant, breastfeeding or intended to become pregnant during study.
(6)Patients who are considered by physicians as inappropriate for the enrollment in this study.

Target sample size

100


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Haruo Shintaku

Organization

Osaka City University Graduate School of Medicine

Division name

Department of Pediatrics

Zip code


Address

1-4-3, Asahimachi, Abenoku, Osaka, 545-8585, Japan

TEL

06-6645-3816

Email

m1155519@med.osaka-cu.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Daisuke Tokuhara

Organization

Osaka City University Graduate School of Medicine

Division name

Department of Pediatrics

Zip code


Address

1-4-3, Asahimachi, Abenoku, Osaka, 545-8585, Japan

TEL

06-6645-3816

Homepage URL


Email

m1155519@med.osaka-cu.ac.jp


Sponsor or person

Institute

Osaka City University Graduate School of Medicine

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Self funding

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

大阪市立大学医学部附属病院小児科


Other administrative information

Date of disclosure of the study information

2016 Year 04 Month 07 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

The changes in body weight, body mass index percentile, or percentage overweight were not significantly different between the two groups at 3 months or at 6 months after the start of GD intake. No adverse events were reported in any of the subjects.

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

2012 Year 09 Month 29 Day

Date of IRB


Anticipated trial start date

2012 Year 11 Month 01 Day

Last follow-up date

2014 Year 09 Month 30 Day

Date of closure to data entry

2014 Year 09 Month 30 Day

Date trial data considered complete

2016 Year 03 Month 31 Day

Date analysis concluded

2016 Year 03 Month 31 Day


Other

Other related information



Management information

Registered date

2016 Year 04 Month 07 Day

Last modified on

2016 Year 04 Month 18 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025163


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name