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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Completed |
Unique ID issued by UMIN | UMIN000017783 |
Receipt No. | R000020599 |
Scientific Title | The effects of olfactory stimulation with foods on mood and body temperatures: a randomized cross-over trial. |
Date of disclosure of the study information | 2015/06/02 |
Last modified on | 2019/03/08 |
Basic information | ||
Public title | The effects of olfactory stimulation with foods on mood and body temperatures: a randomized cross-over trial. | |
Acronym | The effects of olfactory stimulation with foods on mood and body temperatures. | |
Scientific Title | The effects of olfactory stimulation with foods on mood and body temperatures: a randomized cross-over trial. | |
Scientific Title:Acronym | The effects of olfactory stimulation with foods on mood and body temperatures. | |
Region |
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Condition | |||
Condition | Adult | ||
Classification by specialty |
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Classification by malignancy | Others | ||
Genomic information | NO |
Objectives | |
Narrative objectives1 | To investigate the effects of olfactory stimulation with foods on mood and body temperatures in healthy young women. |
Basic objectives2 | Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | |
Trial characteristics_2 | |
Developmental phase |
Assessment | |
Primary outcomes | Mood-related parameter |
Key secondary outcomes | Body temperatures
Autonomic nervous system parameters Awakening scores Gastric motility (electrogastrography) Appetite scores |
Base | |
Study type | Interventional |
Study design | |
Basic design | Cross-over |
Randomization | Randomized |
Randomization unit | Individual |
Blinding | Single blind -participants are blinded |
Control | Placebo |
Stratification | NO |
Dynamic allocation | NO |
Institution consideration | Institution is not considered as adjustment factor. |
Blocking | NO |
Concealment | Pseudo-randomization |
Intervention | ||
No. of arms | 4 | |
Purpose of intervention | Prevention | |
Type of intervention |
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Interventions/Control_1 | Olfactory stimulation using a liquid sample with normal concentration | |
Interventions/Control_2 | Olfactory stimulation using a liquid sample with lower concentration | |
Interventions/Control_3 | Olfactory stimulation using a liquid sample with higher concentration | |
Interventions/Control_4 | Olfactory stimulation using mineral water | |
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 | Female | |||
Key inclusion criteria | 1) Japanese women
2) Age >=20 years, =<25 years 3)Good health conditions determined by the health examination in April 2015 4) Less than 2 kg body weight change within the past one month 5) Having a regular menstrual cycles 6) Informed consent provided |
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Key exclusion criteria | 1) Pregnancy, breast-feeding, or planning a pregnancy
2) Received the medical treatment for hypertension/diabetes/dyslipidemia/heart disease or gastric ulcer 3) During medication 4) Had the excessive fatigue or stress within one month 5) History of smoking 6) Difficulty to determine the smell due to otolaryngology diseases 7) Allergy against foods and drinks using this examination 8) No alcohol tolerance 9) Subjects judged by the project leader to be ineligible for other reasons |
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Target sample size | 12 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | University of Hyogo | ||||||
Division name | School of Human Science and Environment | ||||||
Zip code | |||||||
Address | 1-1-12 Shinzaike-honcho, Himeji, Hyogo, 670-0092 Japan | ||||||
TEL | +81-79-292-1515 | ||||||
nagai@shse.u-hyogo.ac.jp |
Public contact | |||||||
Name of contact person |
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Organization | University of Hyogo | ||||||
Division name | School of Human Science and Environment | ||||||
Zip code | |||||||
Address | 1-1-12 Shinzaike-honcho, Himeji, Hyogo, 670-0092 Japan | ||||||
TEL | +81-79-292-1515 | ||||||
Homepage URL | |||||||
nagai@shse.u-hyogo.ac.jp |
Sponsor | |
Institute | University of Hyogo |
Institute | |
Department |
Funding Source | |
Organization | Suntory Global Innovation Center Ltd. |
Organization | |
Division | |
Category of Funding Organization | Profit organization |
Nationality of Funding Organization |
Other related organizations | |
Co-sponsor | Suntory Global Innovation Center Ltd.(The sample supplier) |
Name of secondary funder(s) |
IRB Contact (For public release) | |
Organization | |
Address | |
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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 | 兵庫県立大学(兵庫県)(University of Hyogo, Hyogo) |
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 | |||||||
Anticipated trial start date |
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Last follow-up date | |||||||
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Date analysis concluded |
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Other | |
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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=R000020599 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |