UMIN-ICDS Clinical Trial

Public title

Effect of a Food Containing Beta-cryptoxanthin to Lipid Metabolism, Liver Function, Glucose Metabolism and Body Fat.

Acronym

Effect of a Food Containing Beta-cryptoxanthin to Lipid Metabolism, Liver Function, Glucose Metabolism and Body Fat.

Scientific Title

Effect of a Food Containing Beta-cryptoxanthin to Lipid Metabolism, Liver Function, Glucose Metabolism and Body Fat.

Scientific Title:Acronym

Effect of a Food Containing Beta-cryptoxanthin to Lipid Metabolism, Liver Function, Glucose Metabolism and Body Fat.

Region

Japan

Condition

N/A (healthy adults)

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

This study aims to examine effect of a food to lipid metabolism, liver function, glucose metabolism and body fat (a randomized, double-blind, placebo-controlled, parallel-group study).

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

[1]LDL-cholesterol (Screening, Week 6, Week 12).

Key secondary outcomes

*Secondary outcomes
[1]Indexes for lipid metabolism (Triglyceride, total cholesterol, HDL cholesterol, atherogenic index, non-HDL cholesterol) (Screening, Week 6, Week 12).
[2]Indexes for liver function (Aspartate aminotransferase, alanine transaminase, gamma-glutamyltransferase) (Screening, Week 6, Week 12).
[3]indexes for glucose metabolism (Blood sugar, HbA1c, HOMA-IR) (Screening, Week 6, Week 12).
[4]Indexes for body fat (Weight, body fat percentage, BMI, waist girth, hip girth / waist-hip ratio) (Screening, Week 6, Week 12).

*Safety
[1]Blood pressure, pulsation (Week 0, Week 4, Week 8, Week 12).
[2]Hematologic test (Week 0, Week 4, Week 8, Week 12).
[3]Blood biochemical test (Week 0, Week 4, Week 8, Week 12).
[4]Urine analysis (Week 0, Week 4, Week 8, Week 12).
[5]Doctor's questions (Week 0, Week 4, Week 8, Week 12).
[6]Subject's diary (From the first day of ingestion of a test material to the last day of the test).

*Other index
[1]Serum beta-cryptoxanthin level (Screening, Week 12).

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Food

Interventions/Control_1

Oral intake of the test product (3 tablets in a day; 12 weeks).

Interventions/Control_2

Oral intake of the placebo product (3 tablets in a day; 12 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

Age-lower limit

20

years-old

<=

Age-upper limit

65

years-old

>

Gender

Male and Female

Key inclusion criteria

[1]Healthy Japanese males and females aged 20-64 years.
[2]Individuals who are healthy and are not suffered from a chronic malady including skin disease.
[3]Individuals whose LDL cholesterol is 120 mg/dl - 139 mg/dl⁽¹⁾.
[4]Individuals whose written informed consent has been obtained.
[5]Individuals who can visit an inspection facility and be inspected in designated days.
[6]Individuals judged appropriate for the study by the principal.
⁽¹⁾A standard value of LDL cholesterol is a target value and when total number of compatible individuals are less than 40, non-compatible individual(s) will be selected as a subject of the study.

Key exclusion criteria

[1]Individuals using medical products.
[2]Individuals who are or are under treatment or have a history of hyperlipidemia, and the other serious disorders.
[3]Individuals who used a drug to treat in the past 1 month.
[4]Individuals who have a history of serious hepatopathy, kidney damage, heart disease, lung disease, or blood disease.
[5]Individuals who have a history of digestive organ disease.
[6]Individuals whose BMI is over 30.
[7]Individuals with serious anemia.
[8]Individuals who are sensitive to a test product or other foods, and medical products.
[9]Individuals who have a nutritional or exercise guidance by a health care provider.
[10]Individuals who are on a diet or have changed an exercise habit in the past 2 months.
[11]Individuals who are alcoholism or excessively take alcohol expressed in an amount of alcohol over 60g/day.
[12]Individuals whose life style will change during the test period.
[13]Individuals who had a habit to ingest foods (ex. health-promoting foods) in the past 3 months or will ingest those foods during the test period.
[14]Individuals who have a habit to intake mandarin juice more than 2 times in 1 week.
[15]Individuals who had intaken averaged 1 mandarin in 1 week from Oct. 2018 to Mar. 2019.
[16]Individuals who regularly intake high beta-cryptoxanthin containing ingredients.
[17]Individuals who had a habit to ingest foods (ex. health-promoting foods) which adopt to improve lipid metabolism, liver function, glucose metabolism and body fat in the past 3 months or will ingest those foods during the test period.
[18]Individuals who donated blood over 200mL in the past 1 month or over 400mL in the past 3 months.
[19]Individuals who are or are possibly pregnant, or are lactating.
[20]Individuals who participated in other clinical studies in the past 3 months.
[21]Individuals who are or whose family is an employee of a health food company.
[22]Individuals judged inappropriate for the study by the principal.

Target sample size

40

Name of lead principal investigator

1st name	Takahiro
Middle name
Last name	Ono

Organization

Ueno-Asagao Clinic

Division name

Head

Zip code

110-0015

Address

6F Kairaku Building 2-7-5 Higashiueno Taito-ku Tokyo 110-0015, JAPAN

TEL

+81-3-6240-1162

Email

info@ueno-asagao.clinc

Name of contact person

1st name	Ryoma
Middle name
Last name	Shimizu

Organization

TES Holdings Co., Ltd.

Division name

Administrative Department of Clinical Trials

Zip code

110-0015

Address

6F Kairaku Building 2-7-5 Higashiueno Taito-ku Tokyo 110-0015, JAPAN

TEL

+81-6801-8480

Homepage URL

Email

r.shimizu@tes-h.co.jp

Institute

TES Holdings Co., Ltd.

Institute

Department

Personal name

Organization

ARKRAY Inc.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Ueno-Asagao Clinic Ethical Review Committee

Address

Kairaku Building 6F, 2-7-5, Higashiueno, Taito-ku, Tokyo, 110-0015 JAPAN

Tel

+81-3-6240-1162

Email

jimukyoku@tes-h.co.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2019

Year

04

Month

11

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

40

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

Recruitment status

Completed

Date of protocol fixation

2019

Year

03

Month

15

Day

Date of IRB

2019

Year

03

Month

18

Day

Anticipated trial start date

2019

Year

04

Month

12

Day

Last follow-up date

2019

Year

07

Month

11

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2019

Year

04

Month

11

Day

Last modified on

2019

Year

09

Month

17

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000041558