UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053941 |
|---|---|
| Receipt number | R000061549 |
| Scientific Title | Effect of Pu-erh tea in the obese parameters of overweight participants: double-blind, randomized controlled trial |
| Date of disclosure of the study information | 2024/03/25 |
| Last modified on | 2024/09/20 10:46:50 |
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Basic information
Public title
Anti-obesity effect of Pu-erh tea drinking in obese parameters (bodyweight and body fat).
Acronym
Anti-obesity effect of Pu-erh tea drinking in obese parameters (bodyweight and body fat).
Scientific Title
Effect of Pu-erh tea in the obese parameters of overweight participants: double-blind, randomized controlled trial
Scientific Title:Acronym
Effect of Pu-erh tea in the obese parameters of overweight participants
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effect of Pu-erh tea on body weight and percent body fat in overweight adults.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change of percent body fat after 12-weeks of administration.
Key secondary outcomes
Change in body weight, waist circumference, serum triglyceride, serum total cholesterol levels.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Duration: 12 weeks
Test drink: Pu-erh tea
Directions and administration: Three times a day, take 200mL of Pu-erh tea bags extracted with boiling water for 3 minutes.
Interventions/Control_2
Duration: 12 weeks
Test food: barley tea
Directions and administration: Three times a day, take 200mL of the infusion of barley tea bags extracted with boiling water for 3 minutes.
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
| 30 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Healthy adult aged 30 to 65 with a BMI of 25 to 30
Key exclusion criteria
1)Subjects who are pregnant or lactating
2)Subjects with a history of stroke, heart disease, or chronic kidney disease
3)Subjects taking antidiabetic drugs, dyslipidemia drugs, hyperuricemia, gout drugs, or antihypertensive drugs
4)Subjects who have developed allergic symptoms to green tea, oolong tea, black tea, Pu-erh tea, barley tea (wheat), etc.
5)Subjects who have not participated in another clinical trial aimed at weight loss for less than 3 months
6)Subjects who are judged as unsuitable for the study by the investigator for the other reason
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | Yuki |
| Middle name | |
| Last name | Shimba |
Organization
University of Shizuoka
Division name
Assistant Professor School of Food and Nutritional Sciences
Zip code
422-8526
Address
52-1 Yada, Suruga-ku, Shizuoka-shi, Shizuoka, 422-8526, Japan
TEL
054-264-5561
shokuji@u-shizuoka-ken.ac.jp
Public contact
Name of contact person
| 1st name | Yuki |
| Middle name | |
| Last name | Shimba |
Organization
University of Shizuoka
Division name
Assistant Professor School of Food and Nutritional Sciences
Zip code
422-8526
Address
52-1 Yada, Suruga-ku, Shizuoka-shi, Shizuoka 422-8526, Japan
TEL
054-264-5561
Homepage URL
shokuji@u-shizuoka-ken.ac.jp
Sponsor or person
Institute
University of Shizuoka
Institute
Department
Personal name
Funding Source
Organization
Tea Life Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Ethics Committee of the University of Shizuoka
Address
52-1 Yada, Suruga-ku, Shizuoka-shi, Shizuoka 422-8526, Japan
Tel
054-264-5103
tyous10@u-shizuoka-ken.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
| 2024 | Year | 03 | Month | 25 | 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
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
Open public recruiting
Date of protocol fixation
| 2024 | Year | 03 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 03 | Month | 11 | Day |
Anticipated trial start date
| 2024 | Year | 03 | Month | 25 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 03 | Month | 22 | Day |
Last modified on
| 2024 | Year | 09 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061549
