UMIN-CTR Clinical Trial

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
Last 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
1st 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