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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Completed |
Unique ID issued by UMIN | UMIN000037222 |
Receipt No. | R000042437 |
Scientific Title | Trial of the efficacy of food ingredients on fatigue in healthy men and women (SWE-2019-04) |
Date of disclosure of the study information | 2020/11/30 |
Last modified on | 2020/08/26 |
Basic information | ||
Public title | Trial of the efficacy of food ingredients on fatigue in healthy men and women (SWE-2019-04) | |
Acronym | Trial of the efficacy of food ingredients on fatigue in healthy men and women | |
Scientific Title | Trial of the efficacy of food ingredients on fatigue in healthy men and women (SWE-2019-04) | |
Scientific Title:Acronym | Trial of the efficacy of food ingredients on fatigue in healthy men and women | |
Region |
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Condition | ||
Condition | Not applicable | |
Classification by specialty |
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Classification by malignancy | Others | |
Genomic information | NO |
Objectives | |
Narrative objectives1 | To evaluate the effect of food ingredients on fatigue. |
Basic objectives2 | Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | |
Trial characteristics_2 | |
Developmental phase |
Assessment | |
Primary outcomes | Fatigue |
Key secondary outcomes |
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 | 4 | |
Purpose of intervention | Prevention | |
Type of intervention |
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Interventions/Control_1 | Intake of the test foods A (8 weeks) | |
Interventions/Control_2 | Intake of the test foods B (8 weeks) | |
Interventions/Control_3 | Intake of the test foods C (8 weeks) | |
Interventions/Control_4 | Intake of the control foods (8 weeks) | |
Interventions/Control_5 | ||
Interventions/Control_6 | ||
Interventions/Control_7 | ||
Interventions/Control_8 | ||
Interventions/Control_9 | ||
Interventions/Control_10 |
Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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Gender | Male and Female | |||
Key inclusion criteria | 1) Women and men aged 40 to 64 years.
2) Person who feels tired with increasing age. 3) Person who feels tired on a daily basis. 4) Person who can come to the medical and inspection organizations for the measurement at the date of visiting. 5) Person who can understand the purpose and content of this study and agree in writing to participate in this study. |
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Key exclusion criteria | 1) Person who has difficulty in implementation of exercise tolerance test.
2) Person whose gets high-intensity exercise on a daily basis 3) Use of product affecting the data of this study, such as food for specified health use, food with function claims, and medicine. 4) Presence of previous and present disease such as chronic fatigue syndrome, sleep apnea syndrome, menopause, lung disorder, cardiovascular disorder, diabetes mellitus, food allergy. 5) Investigator's judgment for other reason. |
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Target sample size | 120 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Suntory Wellness Limited | ||||||
Division name | Institute For Health Care Science | ||||||
Zip code | 619-0284 | ||||||
Address | 8-1-1 Seikadai, Seika-cho, Soraku-gun, Kyoto, 619-0284, Japan | ||||||
TEL | 050-3182-0590 | ||||||
Takao_Tanaka@suntory.co.jp |
Public contact | |||||||
Name of contact person |
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Organization | Suntory Wellness Limited | ||||||
Division name | Institute For Health Care Science | ||||||
Zip code | 619-0284 | ||||||
Address | 8-1-1 Seikadai, Seika-cho, Soraku-gun, Kyoto, 619-0284, Japan | ||||||
TEL | 050-3182-0648 | ||||||
Homepage URL | |||||||
Izumi_Yamasaki@suntory.co.jp |
Sponsor | |
Institute | Suntory Wellness Limited |
Institute | |
Department |
Funding Source | |
Organization | None |
Organization | |
Division | |
Category of Funding Organization | Self funding |
Nationality of Funding Organization |
Other related organizations | |
Co-sponsor | |
Name of secondary funder(s) |
IRB Contact (For public release) | |
Organization | Miura Clinic Research Ethnics Committee |
Address | Higashitenma Bldg. 9F, 1-7-17 Higashitenma, Kita-ku, Osaka, 530-0044, Japan |
Tel | 06-6135-5200 |
info@miura-cl.jp |
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 |
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Related information | |
URL releasing protocol | |
Publication of results | Unpublished |
Result | |
URL related to results and publications | |
Number of participants that the trial has enrolled | |
Results | |
Results date posted | |
Results Delayed | |
Results Delay Reason | |
Date of the first journal publication of results | |
Baseline Characteristics | |
Participant flow | |
Adverse events | |
Outcome measures | |
Plan to share IPD | |
IPD sharing Plan description |
Progress | |||||||
Recruitment status | Completed | ||||||
Date of protocol fixation |
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Date of IRB |
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Anticipated trial start date |
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Last follow-up date |
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Date of closure to data entry | |||||||
Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
Other related information |
Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042437 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |