臨床研究等提出・公開システム

Date of registration	Jan. 06, 2021
Last modified on	Mar. 07, 2022
Trial ID	jRCTs061200042

Scientific Title	Inhibitory effects of anti AGEs supplementation on tissue AGEs in healthy individuals
Public Title	anti AGEs supplementation

Completion date	Jan. 31, 2022
Result actual enrolment	20
Baseline Characteristics	1. Those who do not conflict exclusion criteria age d from 40 to 90 years old. 2. Intake rate of 80% or more for 3 months.
Participant flow	No problem
Adverse events	None
Outcome measures	In anti AGEs supplementaion group, AGEs estimated by AGE reader did not reduce compared to placebo.
Brief summary	No adverse events were identified in the both groups. Blood composition were not significantly changed in either group. In anti advanced glycation endproducts supplementaion group. Insulin resistance index tended to reduce compared to placebo.
Date of posting of results summaries	Feb. 03, 2022

Plan to share IPD	No
Plan description	No
URL link to protocol file(s) with version and date	https://jrct.mhlw.go.jp/latest-detail/jRCTs061200042

Contact for Scientific Queries	Name	Igase Michiya
	Affiliation	Ehime University Hospital
	Address	Shitsukawa, Toon, Ehime
	Telephone	+81-899605932
	E-mail	migase@m.ehime-u.ac.jp
Contact for Public Queries	Name	Igase Michiya
	Affiliation	Ehime University Graduate School of Medicine
	Address	Shitsukawa, Toon, Ehime
	Telephone	+81-89-960-5851
	E-mail	migase@m.ehime-u.ac.jp

Recruitment status	Complete

Anticipated date of first enrollment		Jan. 06, 2021
Target sample size		20
Study Type		Interventional
Study Design	allocation	randomized controlled trial
	masking	double blind
	control	placebo control
	assignment	parallel assignment
	purpose	prevention purpose
Key inclusion & exclusion criteria	Inclusion Criteria	1. Those who do not conflict exclusion criteria aged from 40 to 90 years old. 2. Intake rate of 80% or more for 3 months.
	Exclusion Criteria	1. Persons with a history of serious illness. 2. Those who have abnormal liver function and renal function test values (Based on the standard values of Ehime University Hospital as of December 1, 2020). 3. Persons who have impaired cardiopulmonary function. 4. Those with food and drug allergies. 5. Those who have under one gastrointestinal surgery. 6. Persons with chronic or acute infectious diseases at the discretion of doctors. 7. Participants in other clinical trials at the start of this study. 8. Pregnant person. 9. Other persons who are judged inappropriate by the investigator.
	Age Minimum	40age old over
	Age Maximum	90age old under
	Gender	Both
Health Condition(s) or Problem(s) Studied		none
Intervention(s)		Anti AGEs group: 2220mg per day for three months Placebo group: 2220mg per day for three months
Primary Outcome(s)		skin AGEs and blood AGEs
Secondary Outcome(s)		blood 8-OHdG, MCP-1, pulse wave velocity, carotid echo, hand grip, stabilometer, one leg standing test, blood test (anemia, liver function, renal function, LDL-cholesterol, HDL cholesterol, Triglyceride, BNP, thyroid function, Hba1c, blood sugar, insulin etc.), bone density measurement, questioners

Secondary Sponsor

Secondary Sponsor

Name of Certified Review Board	Certified Review Board, Ehime University
Address	Shitsukawa, Toon, Ehime
Telephone	+81-89-960-5172
E-Mail	rinri@m.ehime-u.ac.jp
Approval Status	Approval
Date of approval	Dec. 04, 2020

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
3	Mar. 07, 2022	(this page)	Changes
2	Mar. 25, 2021	Detail	Changes
1	Jan. 06, 2021	Detail

List of change history