UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045074 |
|---|---|
| Receipt number | R000051495 |
| Scientific Title | A prospective cohort study of taste changes due to weight loss in highly obese patients |
| Date of disclosure of the study information | 2021/08/06 |
| Last modified on | 2022/12/22 16:29:20 |
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Basic information
Public title
A prospective cohort study of taste changes due to weight loss in highly obese patients
Acronym
A study for taste change in obese patients
Scientific Title
A prospective cohort study of taste changes due to weight loss in highly obese patients
Scientific Title:Acronym
A study for taste change in obese patients
Region
| Japan |
Condition
Condition
Obesity
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effect of weight loss on taste (fat taste, umami, sweetness) in severely obese patients
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Taste rank
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
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
| 20 | years-old | <= |
Age-upper limit
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Non-obese patients (BMI less than 25) or highly obese patients (BMI over 30) who are outpatients and hospitalized in the Department of Diabetes and Endocrinology and Metabolism, Wakayama Prefectural Medical University Hospital, and who have consented to the study.
Key exclusion criteria
1. Patients with a history of severe ketosis or diabetic coma within 6 weeks of the start of the study
2. Patients who develop severe hypoglycemia within 6 weeks of the start of the study
3. Patients with severe renal dysfunction (eGFR <15 mL / min / 1.73 m2) or patients with end-stage renal disease on dialysis
4. Patients with proliferative retinopathy (excluding patients who have undergone photocoagulation and have stable state)
5. Patients with severe gastrointestinal disorders within 2 weeks of the study
6. Pregnant or potentially pregnant women and lactating patients
7. Patients with severe infections and serious trauma
8. Patients with other serious food allergies, including dairy products
9. Other patients who the principal investigator deems inappropriate as subjects
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Akiko |
| Middle name | |
| Last name | Tanaka |
Organization
Wakayama Medical University Hospital
Division name
Division of Clinical Nutrition and Metabolism
Zip code
641-8510
Address
811-1 Kimiidera Wakayama city Wakayama Prefecture
TEL
0734410513
atanaka@wakayama-med.ac.jp
Public contact
Name of contact person
| 1st name | Akiko |
| Middle name | |
| Last name | Tanaka |
Organization
Wakayama Medical University Hospital
Division name
Division of Clinical Nutrition and Metabolism
Zip code
641-8510
Address
811-1 Kimiidera Wakayama city Wakayama Prefecture
TEL
0734410513
Homepage URL
atanaka@wakayama-med.ac.jp
Sponsor or person
Institute
Wakayama Medical University Hospital
Institute
Department
Personal name
Funding Source
Organization
Wakayama Medical University Hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethics Committee of Wakayama Medical University
Address
811-1 Kimiidera Wakayama city Wakayama Prefecture
Tel
0734472300
wa-rinri@wakayama-med.ac.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
| 2021 | Year | 08 | Month | 06 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
26
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
| 2020 | Year | 01 | Month | 23 | Day |
Date of IRB
| 2020 | Year | 01 | Month | 23 | Day |
Anticipated trial start date
| 2020 | Year | 01 | Month | 23 | Day |
Last follow-up date
| 2022 | Year | 08 | Month | 19 | Day |
Date of closure to data entry
| 2022 | Year | 08 | Month | 19 | Day |
Date trial data considered complete
| 2022 | Year | 08 | Month | 19 | Day |
Date analysis concluded
| 2022 | Year | 08 | Month | 19 | Day |
Other
Other related information
Questionnaire
Management information
Registered date
| 2021 | Year | 08 | Month | 05 | Day |
Last modified on
| 2022 | Year | 12 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051495
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
