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

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 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

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043502


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name