UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033886 |
|---|---|
| Receipt number | R000038644 |
| Scientific Title | Effect of Dietary Constituent Ingestion on Substrate Metabolism during Exercise under a Condition of No Change of Body Weight |
| Date of disclosure of the study information | 2018/08/27 |
| Last modified on | 2019/05/21 17:37:18 |
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Basic information
Public title
Effect of Dietary Constituent Ingestion on Substrate Metabolism during Exercise under a Condition of No Change of Body Weight
Acronym
Effect of Dietary Constituent Ingestion on Substrate Metabolism during Exercise
Scientific Title
Effect of Dietary Constituent Ingestion on Substrate Metabolism during Exercise under a Condition of No Change of Body Weight
Scientific Title:Acronym
Effect of Dietary Constituent Ingestion on Substrate Metabolism during Exercise
Region
| Japan |
Condition
Condition
Healthy subjects
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect of 2-week ingestion of different dietary constituents on substrate metabolism during exercise in subjects who aged from 40 to less than 60 years and does not form an exercise habit
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Substrate oxidation during exercise (maximum rate, AUC)
Key secondary outcomes
Power output and rate of perceived exertion (RPE) at when indicated a maximum rate of substrate oxidation during exercise. Power output, RPE and respiratory exchange ratio at when indicated a ventilation threshold during exercise
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
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
2-week ingestion of the test food A
Wash out(2 weeks)
2-week ingestion of the placebo
Wash out(2 weeks)
2-week ingestion of the test food B
Interventions/Control_2
2-week ingestion of the test food B
Wash out(2 weeks)
2-week ingestion of the test food A
Wash out(2 weeks)
2-week ingestion of the placebo
Interventions/Control_3
2-week ingestion of the placebo
Wash out(2 weeks)
2-week ingestion of the test food B
Wash out(2 weeks)
2-week ingestion of the test food A
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
| 40 | years-old | <= |
Age-upper limit
| 60 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1)Japanese males and females aged 40 years or older and under 60 years at the time of informed consent acquisition, Japanese males and females who meet the following inclusion criteria for protection of human rights and who do not conflict with the exclusion criteria and are able to comply with the management requirements during the study period.
2)Subjects with BMI of 20.7 to 27.5 in males and 18.8 to 26.0 in females.
3)Non smoker.
4)Persons who have received sufficient explanation on the purpose and content of the research, who have the ability to give consent, who voluntarily volunteers to participate in the research with a good understanding, and who have given written consent to participate in the research.
Key exclusion criteria
1) Currently receiving any medication or ambulatory treatment.
2) Have a history of or complication of serious heart, liver, kidney, cardiovascular system, or blood disorders.
3) Have experienced chest pain or vein abnormalities at rest.
4) Frequent shortness of breath, light-headedness, dizziness, and loss of consciousness.
5) Have a history of drug allergy, food allergy, or allergy to raw materials (milk protein, etc.) used in test foods.
6) Have family member who died suddenly for unknown reasons.
7) Diagnosed with lumbar foot disorders.
8) Taking health foods, supplements, or drugs that may affect fatigue relief.
9) Eat extremely biased meals.
10) Extremely irregular lifestyle habits such as diet and sleep.
11) Suspected of having insomnia (insomnia, sleep apnea syndrome, etc.)
12) Present or past history of psychiatric disorder (depression, etc.)
13) Drug dependence, present illness of alcoholism, previous history.
14) Currently participating in other clinical trials or have participated in other clinical trials within the past 3 months.
15) Irregular working hours, such as those working at night.
16) Feels an effect or pain on the lower back, knee, or body during ascent or descent of stairs, etc.
17) Receiving treatment for rheumatoid arthritis.
18) Have surgery or disease of the knee or routinely use a cane.
19) Body weight fluctuates by +-10 kg or more within 1 year.
20) Wishing to become pregnant during pregnancy, lactation, or during the study period.
21) Difficulties in observing records on various questionnaires.
22) Exercising to maintain or improve physical fitness for at least 60 minutes in total per week.
23) Engaged in physical labor for 10 hours or more in total per week.
24) Scheduled to donate blood or receive vaccination or wishe to donate blood or receive vaccination during the study period.
25) Other, persons who are judged by medical doctor to be inappropriate for the study.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Nosaka |
| Middle name | |
| Last name | Naohisa |
Organization
The Nisshin OilliO Group, Ltd.
Division name
Central Research Laboratory
Zip code
235-8558
Address
1 Shinmori-cho, Isogo-ku, Yokohama, Kanagawa, 235-8558, Japan
TEL
046-837-2488
n-nosaka@nisshin-oillio.com
Public contact
Name of contact person
| 1st name | Masao |
| Middle name | |
| Last name | Matsuoka |
Organization
HUMA R&D CORP
Division name
Clinical Development Division
Zip code
108-0014
Address
Round Cross Tamachi 10F 5-31-19 Shiba Minato-ku Tokyo 108-0014 Japan
TEL
81-3-3431-1260
Homepage URL
matsuoka@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 Nihonbashi Egawa Clinic
Address
2F Kotobuki Build. 1-27-12 Yaesu Chuo-ku, Tokyo 103-0028 Japan
Tel
03-5204-0311
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
| 2018 | Year | 08 | Month | 27 | 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
30
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
| 2018 | Year | 08 | Month | 10 | Day |
Date of IRB
| 2018 | Year | 08 | Month | 13 | Day |
Anticipated trial start date
| 2018 | Year | 09 | Month | 07 | Day |
Last follow-up date
| 2018 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
| 2018 | Year | 12 | Month | 02 | Day |
Date trial data considered complete
| 2018 | Year | 12 | Month | 20 | Day |
Date analysis concluded
| 2019 | Year | 04 | Month | 10 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 08 | Month | 24 | Day |
Last modified on
| 2019 | Year | 05 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038644
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| Registered date | File name |
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| Registered date | File name |
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