Healthy person
Conditions
Interventions
1) Dietary guidance period (2 weeks) Provide meal guidance by meal instruction instructor. 2) Half-ED period (2 weeks) Reduce normal meal volume to about half and administer ED 900 kcal/day. 3) No
Sponsors
Kyorin University School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Healthy person
Exclusion criteria
Exclusion criteria: Exclusion criteria are shown below. 1) Person with history of IBD 2) Person who underwent laparotomy surgery within half a year from the start of the study 3) Person with taking antibiotics within half a year of start the study 4) Major drinkers 5) Person with regularly taking medications 6) Person who can not refrain from intake of foods, supplements, medicines that affect the intestinal environment during the test period 7) Person with metabolism abnormality such as diabetes 8) Person with amino acid metabolic abnormality 9) Person with history of hypersensitivity to the study drug 10) Person with pregnancy / breast-feeding 11) Person who plans to change life style significantly during the examination period 12) Person who has chronic diarrhea easily 13) Person who participated in other clinical trials within the past 3 months 14) Person who can not obtain consent of participation in this clinical study 15) Person who is judged by study responsible doctor as inappropriate as subject
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluation of intestinal flora change by combining analysis results below. 1) fecal analysis (collected at 2, 4, 6 week) 16S metagenomic analysis, metabolome analysis 2) Blood biochemistry (collected at 2, 4, 6 weeks) nutritional indicators (ALB, TP, TC), amino acids, fatty acids | — |
Countries
Japan
Contacts
Public ContactDaisuke Saito
Kyorin University School of Medicine The Third Department of Internal Medicine
Outcome results
None listed