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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000033886
Receipt No. 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

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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
Email 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
Email matsuoka@huma-rd.co.jp

Sponsor
Institute HUMA R&D CORP
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038644

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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