UMIN ID: UMIN000001326
Registered date:01/09/2008
A randomized controlled trial of immune-enhancing enteral feeding on immunologic and nutritional status in tube-fed patients
Basic Information
| Recruitment status | Complete: follow-up complete |
|---|---|
| Health condition(s) or Problem(s) studied | malnutrition |
| Date of first enrollment | 2008/09/01 |
| Target sample size | 126 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | Enteral formula with lactoferrin and nucleic acids (immune-enhancing enteral formula) Enteral formula without lactoferrin and nucleic acids |
Outcome(s)
| Primary Outcome | Natural killer cell activity, phagocytic and sterilizing activity of neutrophils, high sensitive C-reactive protein, albumin, prealbumin |
|---|---|
| Secondary Outcome | Body weight, fever from infectious disease, arm circumference, triceps skinfold thickness, calf circumference |
Key inclusion & exclusion criteria
| Age minimum | 50years-old |
|---|---|
| Age maximum | 95years-old |
| Gender | Male and Female |
| Include criteria | |
| Exclude criteria | 1) Patients with co-morbid diseases which might affect evaluation of study, such as infectious disease. 2) Patients on artificial dialysis. 3) Patients allergic to milk, soybeans, wheat, or fish oil. 4) Patients participating in other clinical trials. 5) Patients who are judged inappropriate for the study by the physician. |
Related Information
| Primary Sponsor | Morinaga Milk Industry Co., Ltd. |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | Morinaga Milk Industry Co., Ltd. |
| Secondary ID(s) |
Contact
| public contact | |
| Name | Yoshiaki Takeuchi |
| Address | 1-5-8, Hatanodai, Shinagawa-ku, Tokyo, Japan Japan |
| Telephone | 03-3784-8535 |
| Affiliation | Showa University, School of Medicine Department of Gastroenterology |
| scientific contact | |
| Name | Yoshiaki Takeuchi |
| Address | 1-5-8, Hatanodai, Shinagawa-ku, Tokyo, Japan Japan |
| Telephone | 03-3784-8535 |
| Affiliation | Showa University, School of Medicine Department of Gastroenterology |