UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038165 |
|---|---|
| Receipt number | R000043502 |
| Scientific Title | Study on the effects of ingestion of water chestnut tea "Hishicha" on body fat |
| Date of disclosure of the study information | 2019/10/04 |
| Last modified on | 2020/04/01 14:58:00 |
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Basic information
Public title
Study on the effects of ingestion of water chestnut tea "Hishicha" on body fat
Acronym
Effects of ingestion of Hishicha on body fat
Scientific Title
Study on the effects of ingestion of water chestnut tea "Hishicha" on body fat
Scientific Title:Acronym
Effects of ingestion of Hishicha on body fat
Region
| Japan |
Condition
Condition
obesity
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effects of long-tern ingestion water chestnut tea "Hishicha" on suppression of body fat.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Visceral fat area
Key secondary outcomes
Height, Body weight, BMI, Body fat percentage, Waist length, Blood pressure, AGEs (Advanced Glycation End Products), Total bilirubin, Total protein, Albumin, AST, ALT, ALP, LD, gamma-GT, Total cholesterol, LDL-cholesterol, HDL-cholesterol, Serum triglyceride, Serum amylase, Urea nitrogen, Creatinine, Uric acid, Na, Cl, K, Direct bilirubin, CK, Cholinesterase, Calcium, Inorganic phosphorus, Serum blood glucose level, White blood cell count, Red blood cell count, Hemoglobin, Hematocrit, Platelet count, Hemoglobin A1c, Dietary survey
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
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
The subjects ingested the active meal for eight weeks.
Interventions/Control_2
The subjects ingested the placebo meal for eight weeks.
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
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Individuals who live or work in Kanzaki city
2) Adults aged 20 to 70 (both male and female)
3) Individuals who are concerned about obesity or visceral fat
4) BMI {weight kg / (height m) 2 or more} is 23 or more and less than 30
5) As a rule, individuals with visceral fat area of 80 cm2 or more or waist length of 81 cm or more
6) Individuals who understand the purpose and contents of the experiment
Key exclusion criteria
1) Individuals who cannot meet the values of residence or work place, age, BMI, visceral fat area or waist circumference
2) Individuals using drugs that may affect lipid metabolism
3) Individuals who cannot stop taking supplements and health foods that may affect lipid metabolism during the test period
4) Individuals suffering from diabetes, kidney / liver disease or being treated
5) Individuals who have been diagnosed with primary dyslipidemia such as familial hypercholesterolemia
6) Individuals with chronic diseases who regularly use drugs
7) Individuals who cannot stop taking large amounts of green tea, oolong tea and black tea during the test period
8) Individuals who are pregnant, those who intend to become pregnant during the test period, breastfeeding individuals
9) Individuals taking part in other food intake and drug use tests, cosmetics and drug application tests
10) Other individuals whose doctors are deemed inappropriate as research subjects
11) Individuals who have been asked to cancel the clinical test
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Midori |
| Middle name | |
| Last name | Yasuda |
Organization
Nishikyushu University
Division name
Faculty of Health and Nutrition Sciences
Zip code
842-8585
Address
4490-9 Osaki, Kanzaki-machi, Kanzaki-shi, Saga, Japan
TEL
0952-37-9274
midori@nisikyu-u.ac.jp
Public contact
Name of contact person
| 1st name | Midori |
| Middle name | |
| Last name | Yasuda |
Organization
Nishikyushu University
Division name
Faculty of Health and Nutrition Sciences
Zip code
842-8585
Address
4490-9 Osaki, Kanzaki-machi, Kanzaki-shi, Saga, Japan
TEL
0952-52-4191
Homepage URL
midori@nisikyu-u.ac.jp
Sponsor or person
Institute
Nishikyushu University
Institute
Department
Personal name
Funding Source
Organization
Kanzaki-shi
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nishikyushu University
Address
4490-9 Osaki, Kanzaki-machi, Kanzaki-shi, Saga, Japan
Tel
0952-52-4191
midori@nisikyu-u.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
| 2019 | Year | 10 | Month | 04 | 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
44
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
| 2019 | Year | 10 | Month | 04 | Day |
Date of IRB
| 2019 | Year | 08 | Month | 19 | Day |
Anticipated trial start date
| 2019 | Year | 10 | Month | 07 | Day |
Last follow-up date
| 2019 | Year | 12 | Month | 16 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 10 | Month | 01 | Day |
Last modified on
| 2020 | Year | 04 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043502
