UMIN ID: UMIN000001301
Registered date:01/01/2009
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.
Basic Information
| Recruitment status | Complete: follow-up complete |
|---|---|
| Health condition(s) or Problem(s) studied | Obesity and impaired glucose tolerance |
| Date of first enrollment | 2008/08/01 |
| Target sample size | 50 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | 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 |
Outcome(s)
| Primary Outcome | Visceral fat accumulation |
|---|---|
| Secondary Outcome | Hemoglobin A1c HOMA index Area under the curb of glucose concentration after 75gOGTT Area under the curb of insurin concentration after 75gOGTT |
Key inclusion & exclusion criteria
| Age minimum | 20years-old |
|---|---|
| Age maximum | 70years-old |
| Gender | Male and Female |
| Include criteria | |
| Exclude criteria | 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. |
Related Information
| Primary Sponsor | Meiji Dairies Corporation |
|---|---|
| Secondary Sponsor | Internal Medicine of Tokushima University Hospital of Medicine and Dentistry |
| Source(s) of Monetary Support | Meiji Dairies Corporation |
| Secondary ID(s) |
Contact
| public contact | |
| Name | Hiromitsu Aonuma |
| Address | 540 Naruda, Odawara, Kanagawa Japan |
| Telephone | 0465-37-3617 |
| HIROMITSU_AONUMA@MEIJI-MILK.COM | |
| Affiliation | Meiji Dairies Corporation Food Science Institute Nutrition Research Department Clinical Study and Scientific Assessment Section |
| scientific contact | |
| Name | Eiji Takeda |
| Address | 3-8-5Kuramoto-cho,Tokushima Japan |
| Telephone | 088-633-7093 |
| Affiliation | University of Tokushima Graduate School Department of Clinical Nutrition |