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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000021826
Receipt No. 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

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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
Institute Osaka City University Graduate School of Medicine
Institute
Department

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
URL(English) https://upload.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


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