UMIN-CTR Clinical Trial

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
Email	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
Email	midori@nisikyu-u.ac.jp

Sponsor
Institute	Nishikyushu University
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000043502