UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049473 |
|---|---|
| Receipt number | R000056328 |
| Scientific Title | Effect of continuous ingestion of dietary components on risk factors for arteriosclerosis under body weight maintenance conditions |
| Date of disclosure of the study information | 2022/11/10 |
| Last modified on | 2024/10/01 15:56:29 |
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Basic information
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
Condition
Healthy subjects
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
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
Assessment
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
Base
Study type
Interventional
Study design
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
Intervention
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
Eligibility
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
Research contact person
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
toya@huma-rd.co.jp
Public contact
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
toya@huma-rd.co.jp
Sponsor or person
Institute
HUMA R&D CORP
Institute
Department
Personal name
Funding Source
Organization
The Nisshin OilliO Group, Ltd.
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
Ethics Committees of Yoga Allergy Clinic
Address
4-32-16 Yoga, Setagaya-ku, Tokyo 158-0097 Japan
Tel
03-5491-4478
jim@medipharma.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
| 2022 | Year | 11 | Month | 10 | 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
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
Progress
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
| 2025 | Year | 09 | Month | 30 | Day |
Other
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.
Management information
Registered date
| 2022 | Year | 11 | Month | 10 | Day |
Last modified on
| 2024 | Year | 10 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056328
