A study of the effect of probiotics on the intestinal environment as a result of protein supplementation -A Randomized, Double-Blind, Placebo-Controlled trial

UMIN ID: UMIN000055574

Registered date:30/09/2024

Basic Information

• Recruitment status: Complete: follow-up continuing
• Health condition(s) or Problem(s) studied: Healthy subjects
• Date of first enrollment: 2024/09/30
• Target sample size: 60
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Test food intake for 4 weeks
Placebo food intake for 4 weeks

Outcome(s)

• Primary Outcome: intestinal environment
• Secondary Outcome: fecal frequency, fecal characteristics, dietary survey, physical examination, skin gas, condition assessment, gastrointestinal symptoms

Key inclusion & exclusion criteria

• Age minimum: 18years-old
• Age maximum: Not applicable
• Gender: Male
• Exclude criteria: 1.Subjects who have a current or past history of liver disease or serious renal, endocrine, cardiovascular, gastrointestinal, pulmonary, hematologic, or metabolic disease. 2.Subjects who regularly use medicine that affect the gut microbiota such as Intestinal regulators, laxatives, etc. 3.Subjects who have lactose intolerance. 4.Subjects who are unable to discontinue foods or supplements containing lactic acid bacteria, bifidobacteria, oligosaccharides, etc. during the study period. 5.Subjects whose daily protein intake is 3.0 g/kg body weight/day or more. 6.Subjects who have drug allergy, food allergy or medical history. 7.Individuals who participated in other clinical trials in the past 1 month or who are going to participate in other trials in this study period. 8.Subjects considered to be inappropriate for this study by the principal investigator based on their background, physical examination, etc.

Related Information

• Primary Sponsor: Juntendo University
• Source(s) of Monetary Support: Morinaga Milk Industry Co., Ltd.