Unique ID issued by UMIN | UMIN000022637 |
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Receipt number | R000026096 |
Scientific Title | A pilot clinical trial on the efficacy of two L-carnitine-based dietary supplements on muscle mass and function in healthy elderly |
Date of disclosure of the study information | 2016/06/11 |
Last modified on | 2017/09/13 16:23:25 |
A pilot clinical trial on the efficacy of two L-carnitine-based dietary supplements on muscle mass and function in healthy elderly
Effect of two L-carnitine-based dietary supplements on muscle mass and function in elderly
A pilot clinical trial on the efficacy of two L-carnitine-based dietary supplements on muscle mass and function in healthy elderly
Effect of two L-carnitine-based dietary supplements on muscle mass and function in elderly
Japan |
Healthy volunteers
Adult |
Others
NO
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.
Efficacy
Exploratory
Not applicable
DXA
Muscle functional and physical/mental status
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
3
Prevention
Food |
Intake of placebo dietary supplement (1 packet/day) for 8 weeks
Intake of L-carnitine-based dietary supplement Carnipure 1 (1 packet/day) for 8 weeks
Intake of L-carnitine-based dietary supplement Carnipure 2 (1 packet/day) for 8 weeks
55 | years-old | <= |
75 | years-old | >= |
Male and Female
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.
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.
60
1st name | |
Middle name | |
Last name | Yoshio Suzuki |
Juntendo University
Graduate School of Health and Sports Science
1-1, Hiragagakuendai, Inzai, Chiba, 270-1695 Japan
+81-476-98-1001
yssuzuki@juntendo.ac.jp
1st name | |
Middle name | |
Last name | Yoshio Suzuki |
Juntendo University
Graduate School of Health and Sports Science
1-1, Hiragagakuendai, Inzai, Chiba, 270-1695 Japan
+81-476-98-1001
yssuzuki@juntendo.ac.jp
Juntendo University Graduate School of Health and Sports Science
Lonza Japan Ltd
Profit organization
NO
2016 | Year | 06 | Month | 11 | Day |
Unpublished
Completed
2016 | Year | 05 | Month | 25 | Day |
2016 | Year | 06 | Month | 11 | Day |
2016 | Year | 06 | Month | 07 | Day |
2017 | Year | 09 | Month | 13 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026096
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