UMIN-ICDS Clinical Trial

Public title

Effect of continuous ingestion of dietary components on risk factors for arteriosclerosis under body weight maintenance conditions

Acronym

Effect of continuous ingestion of dietary components on risk factors for arteriosclerosis under body weight maintenance conditions

Scientific Title

Effect of continuous ingestion of dietary components on risk factors for arteriosclerosis under body weight maintenance conditions

Scientific Title:Acronym

Effect of continuous ingestion of dietary components on risk factors for arteriosclerosis under body weight maintenance conditions

Region

Japan

Condition

Healthy subjects

Classification by specialty

Not applicable

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

The purpose of the study is to examine the effect of continuous ingestion of the test diets on risk factors for arteriosclerosis in Japanese healthy male volunteers aged 35 years or older and younger than 65 years.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

MDA-LDL

Key secondary outcomes

(Secondary outcomes)
LDL-Cho,LP-PLA2,sd-LDL,PAO,Stool examination (fecal microbiome), stool questionnaire parameters (e.g., frequency, characteristics, and amount of stool)
(Safety endpoints)
Vital signs, physical measurements (body weight and BMI), adverse events

Study type

Interventional

Basic design

Cross-over

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

Prevention

Type of intervention

Food

Interventions/Control_1

Continuous ingestion of the test food for 3 weeks
washout
Continuous ingestion of the placebo food for 3 weeks

Interventions/Control_2

Continuous ingestion of the placebo food for 3 weeks
washout
Continuous ingestion of the test food for 3 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

35

years-old

<=

Age-upper limit

65

years-old

>

Gender

Male

Key inclusion criteria

1.Japanese males who are aged 35 years or older and younger than 65 years at the time of written informed consent.
2.Subjects whose BMI is 21 kg/m2 or more and less than 30 kg/m2.
3.Subjects whose LDL-Cho level is 100 mg/dL or more and less than 140 mg/dL.
4.Non-smokers.
5.Subjects whose mean alcohol consumption of less than 30 g per day.
6.Subjects who are fully informed of the purpose and details of the study, capable of giving informed consent, and volunteering to participate in the study based on a full understanding of it, and who have given written informed consent to participate in the study.

Key exclusion criteria

1.Subjects receiving medication or outpatient treatment for a serious disease.
2.Subjects receiving exercise or diet therapy under the supervision of a physician.
3.Subjects who may be allergic to any of the raw materials of the study food or other foods evaluated in the study (wheat, milk components, soybean, chicken, or pork).
4.Subjects with current or previous history of drug dependence or alcohol dependence.
5.Subjects who are currently seeing a doctor for the treatment of a psychiatric disorder (e.g., depression) and/or sleep disorder (e.g., insomnia, sleep apnea syndrome) or have previous history of a psychiatric disorder.
6.Night or shift workers with irregular life patterns.
7.Subjects doing physical work for 10 hours or more per week.
8.Subjects whose eating, sleeping, and other habits are extremely irregular.
9.Subjects who are having a very unbalanced diet.
10.Subjects doing exercise to maintain or improve strength for 30 minutes or more twice a week.

Target sample size

80

Name of lead principal investigator

1st name	Hidemasa
Middle name
Last name	Toya

Organization

HUMA R&D CORP

Division name

Clinical Development Department

Zip code

108-0014

Address

Round Cross Tamachi 9F, 5-31-19 Shiba, Minato-ku, Tokyo 108-0014 Japan

TEL

03-3431-1260

Email

toya@huma-rd.co.jp

Name of contact person

1st name	Hidemasa
Middle name
Last name	Toya

Organization

HUMA R&D CORP

Division name

Clinical Development Department

Zip code

108-0014

Address

Round Cross Tamachi 9F, 5-31-19 Shiba, Minato-ku, Tokyo 108-0014 Japan

TEL

03-3431-1260

Homepage URL

Email

toya@huma-rd.co.jp

Institute

HUMA R&D CORP

Institute

Department

Personal name

Organization

The Nisshin OilliO Group, Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Ethics Committees of Yoga Allergy Clinic

Address

4-32-16 Yoga, Setagaya-ku, Tokyo 158-0097 Japan

Tel

03-5491-4478

Email

jim@medipharma.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

2022

Year

11

Month

10

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

80

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

No longer recruiting

Date of protocol fixation

2022

Year

10

Month

07

Day

Date of IRB

2022

Year

10

Month

14

Day

Anticipated trial start date

2022

Year

11

Month

11

Day

Last follow-up date

2023

Year

04

Month

26

Day

Date of closure to data entry

2023

Year

05

Month

31

Day

Date trial data considered complete

2023

Year

06

Month

15

Day

Date analysis concluded

2024

Year

09

Month

30

Day

Other related information

11.Subjects whose body weight increased or decreased by 5 kg or more in the last 2 months.
12.Subjects with current or previous history of a brain disease, malignancy, immunological disease, diabetes mellitus, hepatic disease (hepatitis), renal disease, cardiac disease, thyroid disease, adrenal disease, metabolic disease, or other serious diseases.
13.Subjects who are intaking olive oil, a healthy food or supplement that affects the antioxidative ability of the body (containing vitamin E, vitamin C, coenzyme Q10, beta-carotene, lycopene, anthocyanin, catechin, or astaxanthin), or a drug and also refusing to stop it during the study period.
14.Subjects who participated in another clinical study/research within 3 months before the date of informed consent or who plan to participate in another clinical study/research during the study period.
15.Subjects who donated more than 200 mL of whole blood, plasma, or platelets within 1 month before the date of informed consent or 400 mL within 3 months before the date of informed consent.
16.Subjects who have difficulty complying with recording of each survey form.
17.Subjects whose laboratory test values or measurements at screening indicate their ineligibility to participate in the study.
18.Other Subjects who are considered ineligible for participation in the study by the investigator.

Registered date

2022

Year

11

Month

10

Day

Last modified on

2024

Year

04

Month

01

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000056328