Unique ID issued by UMIN | UMIN000031123 |
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Receipt number | R000035534 |
Scientific Title | A clinical study to evaluate the effects of sugar-containing vinegar beverage on recovery from fatigue |
Date of disclosure of the study information | 2019/03/31 |
Last modified on | 2023/08/08 18:49:54 |
A clinical study to evaluate the effects of sugar-containing vinegar beverage on recovery from fatigue
A clinical study to evaluate the effects of sugar-containing vinegar beverage on recovery from fatigue
A clinical study to evaluate the effects of sugar-containing vinegar beverage on recovery from fatigue
A clinical study to evaluate the effects of sugar-containing vinegar beverage on recovery from fatigue
Japan |
None
Not applicable | Adult |
Others
NO
To investigate the effects of sugar-containing vinegar beverage on recovery from fatigue: a randomized, double-blind, placebo-controlled, crossover study
Efficacy
Performance test (Physical working capacity test)
Physical endurance (VO2max), Visual analogue scale (fatigue sensation), Autonomic nervous system function, Blood examination
Interventional
Cross-over
Randomized
Individual
Double blind -all involved are blinded
Placebo
2
Treatment
Food |
Intake of test food -> Washout for 4 weeks -> Intake of Placebo
Intake of Placebo -> Washout for 4 weeks -> Intake of test food
30 | years-old | <= |
65 | years-old | > |
Male and Female
The subjects who meet all the conditions in a screening test
1)Healthy people whose age of 30 years or more and less than 65 years old
2) Subjects having a briefing of the content of the present study, fully understanding and agreeing to its objective and being able to personally sign a written informed consent
1) Subjects receiving a medical treatment for serious renal, hepatic, cardio-vascular, respiratory, endocrine or metabolic disorders or having a medical history of these disorders
2) Subjects having the chronic fatigue syndrome (CFS), or subjects deemed to have severe fatigue like idiopathic chronic fatigue by the investigator
3) Subjects having a medical history of chest pain or syncope
4) Subjects having an abnormality in the electrocardiogram
5) Subjects having a subjective symptom of low back pain, arthralgia or lumber hernia, disease of lower limbs, palpitations
6) Subjects who have the possibility of developing allergic symptoms by the test food
7) Subjects who take regularly pharmaceuticals or quasi-drugs which having the efficacy for recovery from fatigue or nutrient replenishment in case of physical fatigue.
8) Subjects who take regularly Foods with Function Claims labeled the effect of attenuating fatigue sensation
9) Subjects who have a seasonal allergic rhinitis (cedar or Japanese cypress pollen) with moderate or severe symptoms
10) Subjects having blood sample of 200 ml or more taken within 1 month, or 400 ml or more within 3 months prior to the start of the present study (e.g. donated blood)
11) Subjects who took part in another clinical study within 3 months prior to the start of the present study or who is currently taking part in another clinical study
12) Female subjects who are pregnant or lactating, or intending to become pregnant during the study
13) Subjects deemed unsuitable by the investigator
24
1st name | |
Middle name | |
Last name | Osami Kajimoto |
Osaka City University Graduate School of Medicine
Department of Medical Science on Fatigue
1-4-3 Asahi-machi, Abeno-ku, Osaka
06-6645-6171
kajimoto@med.osaka-cu.ac.jp
1st name | |
Middle name | |
Last name | Tomohiro Sugino |
Soiken Inc.
R&D Division
Senri Life Science Center 13F, 1-4-2, Shinsenri-higashimachi, Toyonaka, Osaka
06-6871-8888
sugino@soiken.com
Soiken Inc.
Mizkan Co., Ltd.
Profit organization
NO
医療法人弘正会ふくだ内科クリニック(大阪府)
2019 | Year | 03 | Month | 31 | Day |
Unpublished
Completed
2017 | Year | 12 | Month | 16 | Day |
2017 | Year | 12 | Month | 16 | Day |
2018 | Year | 02 | Month | 03 | Day |
2018 | Year | 03 | Month | 25 | Day |
2018 | Year | 02 | Month | 02 | Day |
2023 | Year | 08 | Month | 08 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035534
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