Unique ID issued by UMIN | UMIN000001301 |
---|---|
Receipt number | R000001536 |
Scientific Title | A prospective,randomized,single-blind,comparative study of Inslow,palatinose-based liquid formula and Meibalance,standard balanced liquid formula,using viscera fat accumulation as a primary endpoint in adults patients with confirmed diagnosis of obesity and impaired glucose tolerance. |
Date of disclosure of the study information | 2009/01/01 |
Last modified on | 2010/08/10 09:52:15 |
A prospective,randomized,single-blind,comparative study of Inslow,palatinose-based liquid formula and
Meibalance,standard balanced liquid formula,using viscera fat accumulation as
a primary endpoint in adults patients with
confirmed diagnosis of obesity and impaired glucose tolerance.
A prospective,randomized,single-blind,comparative study of Inslow,palatinose-based liquid formula and Meibalance,standard balanced liquid formula ingested for a certain period,using visceral fat accumulation as a primary endpoint in adults patients with obesity
and impaired glucose tolerance.
A prospective,randomized,single-blind,comparative study of Inslow,palatinose-based liquid formula and
Meibalance,standard balanced liquid formula,using viscera fat accumulation as
a primary endpoint in adults patients with
confirmed diagnosis of obesity and impaired glucose tolerance.
A prospective,randomized,single-blind,comparative study of Inslow,palatinose-based liquid formula and Meibalance,standard balanced liquid formula ingested for a certain period,using visceral fat accumulation as a primary endpoint in adults patients with obesity
and impaired glucose tolerance.
Japan |
Obesity and impaired glucose tolerance
Endocrinology and Metabolism |
Others
NO
To compare mitigation effect of Inslow
(palatinose-based liquid formula)and Meibalance(standard balanced liquid formula)on risk factors of metabolic syndrome in adults patients with obesity
and impaired glucose tolerance. The primary endpoint of efficacy for the study
is visceral fat accumulation.
Safety,Efficacy
Confirmatory
Pragmatic
Not applicable
Visceral fat accumulation
Hemoglobin A1c
HOMA index
Area under the curb of glucose concentration after 75gOGTT
Area under the curb of insurin
concentration after 75gOGTT
Interventional
Parallel
Randomized
Individual
Single blind -investigator(s) and assessor(s) are blinded
Placebo
NO
YES
Institution is considered as adjustment factor in dynamic allocation.
NO
Central registration
2
Treatment
Food |
Inslow(palatinose-based liquid formula)
ingested group
1.Period of intervention:
a)nutritional consultation period;
3 months
b)period of ingestion;6 months
2.Intake amount per day:200 Kcal
3.Intake frequency per day:once a day
Meibalance(standard balanced liquid formula) ingested group
1.Period of intervention:
a)nutritional consultation period;
3 months
b)period of ingestion;6 months
2.Intake amount per day:200 Kcal
3.Intake frequency per day:once a day
20 | years-old | <= |
70 | years-old | >= |
Male and Female
1)Inclusion criteria at the preliminary
registration
1.BMI>=25Kg/m2
2.Fasting glucose concentrations:
100-125mg/dL
3.HbA1c 5.2%-6.5%
4.Volunteers with written informed consent
2)Inclusion criteria at the registration
1.BMI>=25kg/m2
2.Fasting glucose concentrations:
100-125mg/dL
3.HbA1c 5.2%-6.5%
4.Successful volunteers in the nutritional
period
1.Participants recieveing anti-diabetic
drug
2.Deep chronic drinker
3.Participants with following
complications or with past histry
*Exocrine diseases of pancreas:
Pancreatitis;Tumor;
Hemochromatosis,etc.
*Endocrine diseases:
Cushings's syndrome;Acromegaly,
Pheochromocytoma;
Hyperthyroidism,etc.
*Hepatic diseases:Chronic hepatitis,
Hepatic cirrhosis
*Patients with gastrectmy or with chronic
gastro-enteral disease
4.Female who is pregnant, in a lactation
period, child-bearing potential or
wishing to be pregnant.
5.Participants judged to be inadequate by
the investigator.
50
1st name | |
Middle name | |
Last name | Eiji Takeda |
University of Tokushima Graduate School
Department of Clinical Nutrition
3-8-5Kuramoto-cho,Tokushima
088-633-7093
1st name | |
Middle name | |
Last name | Hiromitsu Aonuma |
Meiji Dairies Corporation Food Science Institute
Nutrition Research Department Clinical Study and Scientific Assessment Section
540 Naruda, Odawara, Kanagawa
0465-37-3617
HIROMITSU_AONUMA@MEIJI-MILK.COM
Meiji Dairies Corporation
Meiji Dairies Corporation
Profit organization
Japan
Internal Medicine of Tokushima University
Hospital of Medicine and Dentistry
NO
1)長崎大学医学部・歯学部附属病院(長崎県) 1)Nagasaki University Hospital
2)徳島大学病院 2)Tokushima University Hospital
3)滋賀医科大学病院 3)Shiga Medical University Hospital
4)京都大学病院 4)kyoto University Hospital
5)松原メイフラワー病院 5)Matsubara Mayflower Hospital
2009 | Year | 01 | Month | 01 | Day |
Unpublished
Completed
2008 | Year | 02 | Month | 04 | Day |
2008 | Year | 08 | Month | 01 | Day |
2010 | Year | 10 | Month | 01 | Day |
2010 | Year | 11 | Month | 01 | Day |
2010 | Year | 12 | Month | 01 | Day |
2011 | Year | 03 | Month | 01 | Day |
2008 | Year | 08 | Month | 06 | Day |
2010 | Year | 08 | Month | 10 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001536