UMIN ID: UMIN000002040
Registered date:01/07/2009
The effects of a calorie intake on an energy metabolism in patients with chronic liver diseases
Basic Information
| Recruitment status | Complete: follow-up complete |
|---|---|
| Health condition(s) or Problem(s) studied | Chronic liver diseases |
| Date of first enrollment | 2009/07/01 |
| Target sample size | 120 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | Noramal calorie intake at home, Keep the calorie at home after admission, No additional branched-chain amino acids Noramal calorie intake at home, Keep the calorie at home after admission, Additional branched-chain amino acids Exceeded calorie intake at home, Keep the calorie at home after admission, No additional branched-chain amino acids Exceeded calorie intake at home, Keep the calorie at home after admission, Additional branched-chain amino acids Exceeded calorie intake at home, Normalize the calorie at home after admission, No additional branched-chain amino acids Exceeded calorie intake at home, Normalize the calorie at home after admission, Additional branched-chain amino acids |
Outcome(s)
| Primary Outcome | 1)non-protein respiratory quotient 2)neuro-psychological test 3homeostasis model assessment of insulin resistance 4)nitrogen balance 5)Branched-chain amino acid/Tyrosine molar ratio 6)hospital days |
|---|---|
| Secondary Outcome |
Key inclusion & exclusion criteria
| Age minimum | Not applicable |
|---|---|
| Age maximum | Not applicable |
| Gender | Male and Female |
| Include criteria | |
| Exclude criteria | 1) Calorie intake at home are lower than 80% of standard calorie estimated from Harris-Benedict formula. 2) The concentration of creatinine in the serum was more than 2.0 mg/dl. 3) Allergic reaction was evoked by milk. 4) Hasegawa Dementia Scale revealed an overt dementia 5) Technically it is hard to perform a neuro-psychological test 6) An attending doctor judged inadequate due to any reason |
Related Information
| Primary Sponsor | Niigata Liver Metabolism Study Group |
|---|---|
| Secondary Sponsor | None |
| Source(s) of Monetary Support | None,None |
| Secondary ID(s) |
Contact
| public contact | |
| Name | Tsutomu Kanefuji |
| Address | 1-757 Asahi-Machi, Chuo-Ku, Niigata, Niigata 951-8122 Japan |
| Telephone | 025-227-2207 |
| kanefuji1229@gmail.com | |
| Affiliation | Niigata Liver Metabolism Study Group Excuteive office |
| scientific contact | |
| Name | Takeshi Suda |
| Address | 1-757 Asahi-Machi, Chuo-Ku, Niigata, Niigata 951-8122 Japan |
| Telephone | 025-227-2207 |
| tspitt@med.niigata-u.ac.jp | |
| Affiliation | Niigata University Graduate School of Medical and Dental Sciences Department of Gastroenterology and Hepatology |