Unique ID issued by UMIN | UMIN000021826 |
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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 |
Evaluation of effectiveness of globin digest in obese children (the approved number: 2394)
Globin digest study
Evaluation of effectiveness of globin digest in obese children (the approved number: 2394)
Globin digest study
Japan |
Obesity
Pediatrics |
Others
NO
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.
Safety
Confirmatory
Not applicable
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
Adverse events
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
YES
YES
Institution is not considered as adjustment factor.
NO
Central registration
2
Treatment
Food |
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.
Placebo group were given placebo beverage with a similar taste and appearance in a same manner as well as GD beverage.
6 | years-old | <= |
18 | years-old | > |
Male and Female
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)
(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.
100
1st name | |
Middle name | |
Last name | Haruo Shintaku |
Osaka City University Graduate School of Medicine
Department of Pediatrics
1-4-3, Asahimachi, Abenoku, Osaka, 545-8585, Japan
06-6645-3816
m1155519@med.osaka-cu.ac.jp
1st name | |
Middle name | |
Last name | Daisuke Tokuhara |
Osaka City University Graduate School of Medicine
Department of Pediatrics
1-4-3, Asahimachi, Abenoku, Osaka, 545-8585, Japan
06-6645-3816
m1155519@med.osaka-cu.ac.jp
Osaka City University Graduate School of Medicine
None
Self funding
NO
大阪市立大学医学部附属病院小児科
2016 | Year | 04 | Month | 07 | Day |
Unpublished
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.
Completed
2012 | Year | 09 | Month | 29 | Day |
2012 | Year | 11 | Month | 01 | Day |
2014 | Year | 09 | Month | 30 | Day |
2014 | Year | 09 | Month | 30 | Day |
2016 | Year | 03 | Month | 31 | Day |
2016 | Year | 03 | Month | 31 | Day |
2016 | Year | 04 | Month | 07 | Day |
2016 | Year | 04 | Month | 18 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025163
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