臨床研究等提出・公開システム

Date of registration	Sept. 13, 2019
Last modified on	Sept. 25, 2020
Trial ID	jRCT1030190095

Scientific Title	Evaluation of fatigue reduction by food containing CoQ10 and krill oil
Public Title	CoQ10 trial

Completion date	Dec. 25, 2019
Result actual enrolment	51
Baseline Characteristics	Fifty-four individuals entered the study and 18 were assigned to each of the three groups (test article group (CoQ10 and krill oil) , control article group(CoQ10 only), placebo group). One person included in the placebo group did not participate. The study started with 53 people. The breakdown of 53 people was 24 men, 29 women, and average age 57.8 years.
Participant flow	Fifty-three (test sample group; 18, control group; 18, placebo group; 17) started the study. Two people (test sample group; 1, control product group;1) discontinued the study due to their own circumstances (work convenience; one, fever due to cold; one).Fifty-one (test sample group; 17, control group; 17, placebo group; 17) completed the study. The breakdown of the 51 persons was 23 males, 28 females, and an average age of 57.8 years (50 to 70 years old).
Adverse events	none
Outcome measures	Comparison with before start: In the test product group, "autonomic nerve activity" and "deviation value" were significantly increased (improved), and "autonomic nerve function age" and "fatigue" were significantly decreased (improved). In the control product group, there was a decreasing tendency in "autonomic nervous function age", and a significant decrease in "feeling of fatigue". The placebo group showed a significant reduction in "feeling of fatigue". Comparison of changes between groups: In the test product group, the "autonomic nerve activity" and "deviation value" tended to increase compared to the control product group. Compared to the placebo group, the test product group showed an increasing tendency in "deviation value" and a decreasing tendency in "functional age", and there was a significant difference in "autonomic nerve activity".
Brief summary	As a result of continuous ingestion of the test sample (CoQ10 and krill oil) for 12 weeks, the amount of activity of autonomic nerves and autonomic nerve function age were improved, and the feeling of fatigue was reduced. It was thought to have the effect of reducing fatigue. It was also suggested that blending CoQ10 and krill oil has a greater effect of reducing fatigue than using CoQ10 only.
Date of posting of results summaries	June. 28, 2020
Date of the first journal publication of results	June. 28, 2020
URL hyperlink(s) related to results and publications	https://www.shinryo-to-shinyaku.com/sin_0057_06.html

Plan to share IPD	No
Plan description	none
URL link to protocol file(s) with version and date	https://jrct.mhlw.go.jp/latest-detail/jRCT1030190095

Contact for Scientific Queries	Name	Miyata Akinobu
	Affiliation	Nihonbashi M's Clinic
	Address	9F, 2-2-8 Nihonbashi, Tyuuouku, Tokyo
	Telephone	+81-3-5204-3088
	E-mail	info@nihonbashi-ms-clinic.com
Contact for Public Queries	Name	Kaneko Takeshi
	Affiliation	Japan Clinical Trial Association
	Address	5F, 4-3-17 Shinjuku, Shinjukuku, Tokyo
	Telephone	+81-3-6302-0593
	E-mail	jacta@usjri.com

Recruitment status	Complete

Anticipated date of first enrollment		Sept. 13, 2019
Target sample size		54
Study Type		Interventional
Study Design	allocation	randomized controlled trial
	masking	double blind
	control	placebo control
	assignment	parallel assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	Subjects who are tired
	Exclusion Criteria	1. Subject with a history of food allergy 2. Subject who are pregnant or nursing 3. Subjects taking health food that has effect 4. Subjects taking medication to bring about the effect 5. Subjects with frail constitution, Subjects with chronic fatigue
	Age Minimum	50age old over
	Age Maximum	70age old under
	Gender	Both
Health Condition(s) or Problem(s) Studied		Healthy adult
Intervention(s)		Evaluate fatigue level by continuously taking test article for 12 weeks
Primary Outcome(s)		instrument measurement, VAS, Chalder fatigue scale
Secondary Outcome(s)		questionnaire

Source of Monetary Support / Secondary Sponsor	EC STUDIO Co., Ltd.
Secondary Sponsor	Not applicable

Name of Certified Review Board	JSSRM of CRB
Address	Shinjuku Park Tower 30F, 3-7-1 nishishinjuku, shinjukuku, Tokyo
Telephone	+81-3-5326-3129
E-Mail	rinsyo@jssrm.com
Approval Status	Approval
Date of approval	Sept. 12, 2019

Secondary ID(s)	UMIN000037784
Issuing Authority	University hospital Medical Information Network (UMIN) Center

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
2	Sept. 25, 2020	(this page)	Changes
1	Sept. 13, 2019	Detail

List of change history