UMIN-CTR Clinical Trial

Basic information
Public title	Effect of continuous intake of dietary components on postprandial substrate metabolism under dietary maintenance conditions
Acronym	Effect of continuous intake of dietary components on postprandial substrate metabolism under dietary maintenance conditions
Scientific Title	Effect of continuous intake of dietary components on postprandial substrate metabolism under dietary maintenance conditions
Scientific Title:Acronym	Effect of continuous intake of dietary components on postprandial substrate metabolism under dietary maintenance conditions
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 4-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), fatty acid conversion, respiratory exchange ratio (during exercise)
Key secondary outcomes	(Secondary outcomes) Postprandial body heat production (during rest), carbohydrate oxidation (during exercise), visceral fat measurement, heart rate variability (Safety evaluation) Vital signs, body measurements(weight,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	4-week ingestion of the test food Wash out(5 weeks or more) 4-week ingestion of the placebo food
Interventions/Control_2	4-week ingestion of the placebo food Wash out(5 weeks or more) 4-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 between 35 and 65 years old at the time of obtaining written consent. 2)Subject with BMI >=25kg/m2 and <30kg/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 receiving the rheumatism treatment. 6.Subject who frequently has shortness of breath, lightheadedness, dizziness or loss of consciousness. 7.Subject who might has or has a history of drug allergies, food allergies, allergies to test foods, or allergies to raw materials for evaluated foods(soybeans, milk protein, pork). 8.Subject who has difficulty ingesting test foods and evaluation foods. 9.Subject who has a family member who died suddenly of unknown causes. 10.Subject who has been diagnosed as having problems with the legs and hips. 11.Subject who feels pain in their hips, knees, or body when ascending or descending stairs, etc. 12.Subject with knee surgery or disease, or those who use a cane on a daily basis. 13.Subject with current or history of drug or alcohol dependence. 14.Subject who attends a hospital due to mental disorders (depression, etc.) or sleep disorders (Insomnia, sleep apnea syndrome, etc.), or who has a history of mental illness in the past. 15.Subject who exercises for the purpose of maintaining or improving their physical fitness for a total of 60 minutes or more per week.
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Hidemasa Middle name Last name Toya
Organization	HUMA R&D CORP
Division name	Clinical Development Department
Zip code	108-0014
Address	Round Cross Tamachi 10F 5-31-19 Shiba Minato-ku Tokyo 108-0014 Japan
TEL	03-3431-1260
Email	toya@huma-rd.co.jp

Public contact
Name of contact person	1st name Hidemasa Middle name Last name Toya
Organization	HUMA R&D CORP
Division name	Clinical Development Department
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	toya@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	2022 Year 01 Month 13 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
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	Preinitiation
Date of protocol fixation	2021 Year 12 Month 03 Day
Date of IRB	2021 Year 12 Month 10 Day
Anticipated trial start date	2022 Year 01 Month 14 Day
Last follow-up date	2022 Year 06 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other

Other related information

(Exclusion criteria continued) 16.Subject who performs physical labor for a total of 10 hours or more per week. 17.Subject whose working hours are irregular due to night shifts, etc. 18.Subject with a weight fluctuation of more than +-5 kg within 2 months. 19.Subject who has extremely irregular lifestyle habits such as eating and sleeping. 20.Subject who has an extremely unbalanced diet. 21.Subject who are using or cannot stop using health foods, supplements, or medicines that affect fatigue reduction, fat burning and obesity control. 22.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. 23.Subject who has blood collection or donation more than 200mL within the past 1 month or more than 400mL within the past 3 months from the day of the consent acquisition. 24.Subject who plans or wish to donate blood or get vaccinated during the test period. However, this does not apply to vaccination against the new coronavirus. 25.Subject who is planning to get pregnant after the day of informed consent or is currently pregnant and lactating. 26.Subject who has difficulty observing records on various survey forms. 27.Subject who is judged as an inappropriate candidate according to the screening data. 28.Subject who is considered as an inappropriate candidate by the doctor in charge.

Management information
Registered date	2022 Year 01 Month 12 Day
Last modified on	2022 Year 01 Month 05 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053101

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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