UMIN-CTR Clinical Trial

Basic information
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
Condition	N/A (healthy adults)
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
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

Assessment
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).

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	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

Eligibility
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

Research contact person
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

Public contact
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

Sponsor
Institute	TES Holdings Co., Ltd.
Institute
Department

Funding Source
Organization	ARKRAY Inc.
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	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
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 04 Month 11 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	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

Progress
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
Other related information

Management information
Registered date	2019 Year 04 Month 11 Day
Last modified on	2019 Year 09 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041558