UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A pilot clinical trial on the efficacy of two L-carnitine-based dietary supplements on muscle mass and function in healthy elderly
Title of the study (Brief title)	Effect of two L-carnitine-based dietary supplements on muscle mass and function in elderly
Region	Japan

Condition
Condition	Healthy volunteers
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The objective of this exploratory study is to evaluate the effects of two L-carnitine-based dietary supplements on muscle mass and function, and physical/mental status.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	DXA
Key secondary outcomes	Muscle functional and physical/mental status

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	3
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Intake of placebo dietary supplement (1 packet/day) for 8 weeks
Interventions/Control_2	Intake of L-carnitine-based dietary supplement Carnipure 1 (1 packet/day) for 8 weeks
Interventions/Control_3	Intake of L-carnitine-based dietary supplement Carnipure 2 (1 packet/day) for 8 weeks
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	55 years-old <=
Age-upper limit	75 years-old >=
Gender	Male and Female
Key inclusion criteria	1. Healthy male and female adults, aged 55 to 75 years 2. BMI of 21 kg/m2 to 33 kg/m2 3. Subjects in good physical condition such that they can perform exercise testing safely, 4. Subjects who are sedentary and not currently engaging in any regular exercise. 5. Subjects who agree to maintain their current level of activity throughout the trial period. 6. Subjects who have given voluntary, written, informed consent to participate in the study.
Key exclusion criteria	1. Subjects who are smokers but smokes more than one box a day. 2. Subjects who have experienced weight loss or gain of greater than 4.5 kg (approximately 10 lbs.) in the past 3 months 3. Subjects diagnosed with active heart disease 4. Subjects with uncontrolled hypertension (=> 160 mmHg) 5. Subjects with history of seizure 6. Present or history of neurological disorders or significant psychiatric illness 7. Subjects with gout 8. Subject with significant heart, liver, kidney, blood or respiratory disease 9. Subjects with Type I or Type II diabetes 10. Subjects with unstable thyroid disease 11. Use of another investigational product within 3 month of the screening visit 12. Subjects with an allergy or sensitivity to the investigational dietary supplement ingredient. 13. Subjects who use illicit drugs or have a history of alcohol or drug abuse within the past 6 months 14. Subjects who currently consume greater than 2 standard alcoholic drinks per day.
Target sample size	60

Research contact person
Name of lead principal investigator	Yoshio Suzuki
Organization	Juntendo University
Division name	Graduate School of Health and Sports Science
Address	1-1, Hiragagakuendai, Inzai, Chiba, 270-1695 Japan
TEL	+81-476-98-1001
Email	yssuzuki@juntendo.ac.jp

Public contact
Name of contact person	Yoshio Suzuki
Organization	Juntendo University
Division name	Graduate School of Health and Sports Science
Address	1-1, Hiragagakuendai, Inzai, Chiba, 270-1695 Japan
TEL	+81-476-98-1001
Homepage URL
Email	yssuzuki@juntendo.ac.jp

Sponsor
Institute	Juntendo University Graduate School of Health and Sports Science
Institute
Department

Funding Source
Organization	Lonza Japan Ltd
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2016 Year 06 Month 11 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 05 Month 25 Day
Anticipated trial start date	2016 Year 06 Month 11 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 06 Month 07 Day
Last modified on	2017 Year 09 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026096