UMIN-CTR Clinical Trial

Basic information
Public title	Effect of continuous ingestion of dietary components on postprandial substrate metabolism under conditions without weight fluctuation
Acronym	Effect of continuous ingestion of dietary components on postprandial substrate metabolism under conditions without weight fluctuation
Scientific Title	Effect of continuous ingestion of dietary components on postprandial substrate metabolism under conditions without weight fluctuation
Scientific Title:Acronym	Effect of continuous ingestion of dietary components on postprandial substrate metabolism under conditions without weight fluctuation
Region	Japan

Condition
Condition	Healthy subjects
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the effect on postprandial substrate metabolism during rest and exercise, middle-aged and elderly pre-obese who do not have exercise habits ingest test diets with different dietary components continuously for 2-weeks.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Stable isotope excretion after test meals (during rest and exercise)
Key secondary outcomes	(Secondary outcomes) Postprandial substrate oxidation, respiratory exchange ratio (during rest and exercise) (Safety evaluation) Vital signs, 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	2-week ingestion of the test food Wash out(2 weeks) 2-week ingestion of the placebo food
Interventions/Control_2	2-week ingestion of the placebo food Wash out(2 weeks) 2-week ingestion of the test food
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 and Female
Key inclusion criteria	1)Japanese men and women aged 35 to 64 years old at the time of informed consent. 2)Subject with BMI from 25 less than 30 (unit: kg/m2). 3)Non-smoker 4)Subject with alcohol intake less than 30g / day. 5)Subject who has received sufficient explanation of the purpose and content of the research, has the ability to consent.
Key exclusion criteria	1)Subject who is taking medication or under medical treatment due to serious illness. 2)Subject who has experienced chest pain or abnormal pulse at rest. 3)Subject who is under exercise therapy or dietetic therapy. 4)Subject with serious current illness or complications or history such as heart disease, liver disease, kidney disease, cardiovascular disease, blood disease, etc. 5)Subject who is treating rheumatism. 6)Subject who frequently experiences shortness of breath, dizziness, and loss of consciousness. 7)Subject who has or had a history of drug allergies, food allergies, or allergies to raw materials for test foods (soybeans, milk protein). 8)Subject who has a family member who died suddenly of unknown causes. 9)Subject who has been diagnosed as having problems with the legs and hips. 10)Subject who feels pain in their hips, knees, or body when ascending or descending stairs, etc. 11)Subject with knee surgery or disease, or those who use a cane on a daily basis. 12)Subject who has or had a history of either medicine or alcohol dependence syndrome. 13)Subject who has or had suspected of disorder with mental (such as depression) or sleep (such as insomnia and sleep apnea syndrome). 14)Subject who exercises for the purpose of maintaining or improving their physical fitness for a total of 60 minutes or more per week. 15)Subject who performs physical labor for a total of 10 hours or more per week. 16)Subject whose working hours are irregular due to night shifts, etc. 17)Subject with a weight fluctuation of more than +-5 kg within 2 months. 18)Subject who has extremely irregular lifestyle such as eating and sleeping. 19)Subject who has an unbalanced diet. 20)Subject who uses health foods, supplements, or drugs that affect fatigue reduction, fat burning, or obesity control.
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Daisuke Middle name Last name Ochitani
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	03-3431-1260
Email	ochitani@huma-rd.co.jp

Public contact
Name of contact person	1st name Daisuke Middle name Last name Ochitani
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	03-3431-1260
Homepage URL
Email	ochitani@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 Yoga Allergy Clinic
Address	4-32-16 Yoga,Setagaya-ku,Tokyo 158-0097 Japan
Tel	03-5491-4478
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	2021 Year 01 Month 15 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	2021 Year 01 Month 06 Day
Date of IRB	2021 Year 01 Month 15 Day
Anticipated trial start date	2021 Year 01 Month 18 Day
Last follow-up date	2021 Year 04 Month 23 Day
Date of closure to data entry	2021 Year 04 Month 30 Day
Date trial data considered complete	2021 Year 05 Month 12 Day
Date analysis concluded	2021 Year 09 Month 30 Day

Other

Other related information

(Exclusion criteria continued) 21)Subject who has participated in other clinical studies within the past 3 months from the day of the consent acquisition or who is planning to participate in other clinical studies during the current study. 22)Subject who has blood collection or donation more than 200mL within the past 1 months or more than 400mL within the past 3 months from the day of the consent acquisition. 23)Subject who plans or wish to donate blood or get vaccinated during the test period. 24)Subject who is planning to get pregnant during the test period after the day of informed consent or is currently pregnant and lactating. 25)Subject who can't keep the daily records. 26)Subject who is judged as an inappropriate candidate according to the screening data. 27)Subject who is considered as an inappropriate candidate by the doctor in charge.

Management information
Registered date	2021 Year 01 Month 15 Day
Last modified on	2021 Year 10 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049074