Research on the effects of dietary fiber on short-chain fatty acid production in the gut microbiota.

JRCT ID: jRCTs051220163

Registered date:03/02/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Healthy people
• Date of first enrollment: 06/04/2023
• Target sample size: 8
• Study type: Interventional
• Intervention(s): Subjects take the two assigned dietary fiber foods as test drugs, 3 g each time, twice a day, for 6 consecutive weeks, with a washout period of 4 weeks in between.

Outcome(s)

• Primary Outcome: Changes in short-chain fatty acids in feces before and after starting test drug (comparison of changes in short-chain fatty acids before and after administration in one individual)

Secondary Outcome

Exploratory endpoint
1. Changes in responsiveness to various dietary fibers by MyDFFS before and after starting the test drug.
2. Changes in the composition of the intestinal flora before and after starting the study drug.

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 70age old
• Gender: Both

Include criteria

(1) Persons aged between 20 and 70 at the time of obtaining consent
(2) Regardless of gender
(3) Patients who gave their voluntary written consent to participate in this clinical research
(4) Subjects who can or are expected to be able to continue their usual dietary habits and intake of supplements during the study period

Exclude criteria

(1) Subjects with a history of diabetes, liver disease, kidney disease, heart disease, lung disease, or other serious diseases
(2) Subjects who are currently undergoing treatment
(3) Subjects with food and drug allergies
(4) Others who are deemed inappropriate by the person in charge of this clinical study

Related Information

• Primary Sponsor: Kodama Yuzo
• Secondary Sponsor: Osawa Ro
• Secondary ID(s): Nil known