UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041607 |
|---|---|
| Receipt number | R000047494 |
| Scientific Title | Effects of test food on lipid metabolism |
| Date of disclosure of the study information | 2020/09/15 |
| Last modified on | 2021/05/31 14:04:13 |
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Basic information
Public title
Effects of test food on lipid metabolism
Acronym
Effects of test food on lipid metabolism
Scientific Title
Effects of test food on lipid metabolism
Scientific Title:Acronym
Effects of test food on lipid metabolism
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to examine effects of test food on lipid metabolism.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Expired-gas measurement
(lipid oxidation, carbohydrate oxidation, respiratory quotient)
Key secondary outcomes
Serum free fatty acid concentration, pulse rate
(oxidative stress-antioxidant potential, concentration of serum lipid metabolites and hormones, oxygen consumption, and serum T-cho, LDL-Cho, HDL-Cho, TG and Glucose concentration)
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
Diagnosis
Type of intervention
| Food |
Interventions/Control_1
Oral ingestion of the test food for two weeks
Interventions/Control_2
Oral ingestion of the placebo food for two 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
| 30 | years-old | <= |
Age-upper limit
| 60 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Individuals aged 30-59 years.
2) Individuals who are healthy (BMI >=18.5 and <30).
3) Individuals who can visit an inspection facility and be inspected in designated days.
4) Individuals who can pedal the cycle ergometer for more than 30 minutes.
5) Individuals who don't have regular exercise more than twice a week now or in the past 6 months.
6) Individuals whose written informed consent has been obtained.
Key exclusion criteria
1) Individuals who take foods more than three times a week with functional claims or foods or supplements containing Passienol-TM now or in the past 1 month, or will take them for this test period.
2) Individuals who take medications more than three times a week now or in the past 1 month, or will take them for this test period.
3) Individuals who take food for specified health use or foods with functional claims or supplements claiming to improve lipid metabolism more than three times a week now or in the past 1 month, or will take them for this test period.
4) Individuals who are allergic to especially foods or medicines or rubber.
5) Individuals who have currently or a history of hepatopathy, kidney damage, heart disease, lung, and gastrointestinal disease.
6) Individuals who were hospitalized in the past 6 months, or will be hospitalized for this test period.
7) Individuals who are currently treating anemia.
8) Individuals who are expected to have severe menstrual pain at one of the three cycle ergometer tests.
9) Females who are or are possibly pregnant, or are lactating.
10) Individuals who are a smoker.
11) Individuals who are heavy drinker of alcohol.
12) Individuals who have irregular life rhythms such as shift workers and late-night workers.
13) Individuals who participated in other clinical studies in the past 4 weeks, or will participate for this test period.
14) Individuals who donated total more than 200mL whole blood or blood component for the past 1 month.
15) Males who donated total more than 400mL whole blood for the past 3 months.
16) Females who donated total more than 400mL whole blood for the past 4 months.
17) Males who will donate total more than 1200mL blood for the past 12 months and this test period.
18) Females who will donate total more than 1200mL blood for the past 8 months and this test period.
19) Individuals judged inappropriate for this study by the principal investigator.
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | Hiroko |
| Middle name | |
| Last name | Uchida |
Organization
MORINAGA & CO., LTD.
Division name
Health Science and Research Center, R&D institute
Zip code
230-8504
Address
2-1-1, Shimodueyoshi, Tsurumi-ku, Yokohama
TEL
045-571-6140
h-uchida-ji@morinaga.co.jp
Public contact
Name of contact person
| 1st name | Naoko |
| Middle name | |
| Last name | Matsui |
Organization
MORINAGA & CO., LTD.
Division name
Health Science and Research Center, R&D institute
Zip code
230-8504
Address
2-1-1, Shimodueyoshi, Tsurumi-ku, Yokohama
TEL
045-571-6140
Homepage URL
n-matsui-ah@morinaga.co.jp
Sponsor or person
Institute
Morinaga & Co., Ltd
Institute
Department
Personal name
Funding Source
Organization
Morinaga & Co., 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
Institutional Review Board of Chiyoda Paramedical Care Clinic
Address
4F Sanwauchikanda Building, 3-3-5 Uchikanda, Chiyoda-ku, Tokyo
Tel
03-5297-3112
IRB@cpcc.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
| 2020 | Year | 09 | Month | 15 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
12
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
Main results already published
Date of protocol fixation
| 2020 | Year | 08 | Month | 12 | Day |
Date of IRB
| 2020 | Year | 08 | Month | 21 | Day |
Anticipated trial start date
| 2020 | Year | 08 | Month | 24 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 08 | Month | 30 | Day |
Last modified on
| 2021 | Year | 05 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047494
| Research Plan | |
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| Registered date | File name |
| Research case data | |
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