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Japanese

Feb. 03, 2023

Nov. 17, 2023

jRCTs051220163

An exploratory study to evaluate the effects of dietary fiber on short-chain fatty acid production in the gut microbiota of healthy subjects

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

Kodama Yuzo

Kobe University Hospital

7-5-2 Kusunoki-cho, Chuo-ku, kobe city, Hyogo

+81-783826305

kodama@med.kobe-u.ac.jp

Inoue Jun

Kobe University Hospital

7-5-2 Kusunoki-cho, Chuo-ku, kobe city, Hyogo

+81-783826305

juninoue@med.kobe-u.ac.jp

Recruiting

Feb. 03, 2023

April. 06, 2023
8

Interventional

non-randomized controlled trial

single blind

uncontrolled control

single assignment

treatment purpose

(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

(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

20age old over
70age old under

Both

Healthy people

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.

D040361

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)

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.

Kobe University Clinical Research Ethical Committee
7-5-2 Kusunoki-cho, Chuo-ku, kobe city, Hyogo

+81-78-382-6669

cerb@med.kobe-u.ac.jp
Approval

Dec. 12, 2022

なし
none

none

History of Changes

No Publication date
3 Nov. 17, 2023 (this page) Changes
2 Nov. 15, 2023 Detail Changes
1 Feb. 03, 2023 Detail