UMIN-CTR Clinical Trial

Basic information
Public title	The effects of postprandial food intake on subsequence metabolism, digestion and absorption
Acronym	The effects of postprandial food intake on subsequence metabolism
Scientific Title	Evaluation of the effects of postprandial food intake on energy expenditure, digestion and absorption
Scientific Title:Acronym	The effects of postprandial food intake on energy expenditure
Region	Japan

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

Objectives
Narrative objectives1	To examine the effects of postprandial food intake on diet-induced thermogenesis, digestion and absorption in healthy adults
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Energy expenditure
Key secondary outcomes	lipid and carbohydrate metabolism, and digestion and absorption speed

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -participants 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	Participants consume test foods after a standardised meal. Then, diet-induced thermogenesis, digestion and absorption are evaluated for 4 hours.
Interventions/Control_2	Participants consume control foods after a standardised meal. Then, diet-induced thermogenesis, digestion and absorption are evaluated for 4 hours.
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	20 years-old <=
Age-upper limit	69 years-old >
Gender	Male and Female
Key inclusion criteria	1)Healthy men and women age between 20 and 69 years old (body mass index between 22 and 30) 2)A participant who consumes the test and control foods on a daily basis
Key exclusion criteria	1)Not age between 20 and 69 years old 2)Not body mass index between 22 and 30 3)A pregnant and breastfeeding women 4)A participant who has systolic blood pressure is over 140 mmHg or diastolic blood pressure is over 90 mmHg 5)A participant who has a digestive problem 6)A participant who has a digestive disease in the past 3 months 7)A participant who has a digestive tract surgery in the past 3 months 8)A participant who has food allergies
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Masashi Middle name Last name Miyashita
Organization	Waseda University
Division name	Faculty of Sport Sciences
Zip code	359-1192
Address	2-579-15 Mikajima,Tokorozawa, Saitama
TEL	04-2947-6774
Email	m.miyashita@waseda.jp

Public contact
Name of contact person	1st name Masashi Middle name Last name Miyashita
Organization	Waseda University
Division name	Faculty of Sport Sciences
Zip code	359-1192
Address	2-579-15 Mikajima,Tokorozawa, Saitama
TEL	04-2947-6774
Homepage URL
Email	m.miyashita@waseda.jp

Sponsor
Institute	Waseda University
Institute
Department

Funding Source
Organization	Lotte Co., 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	Waseda University
Address	1-104 Totsuka-cho, shinjuku-ku, Tokyo
Tel	03-5272-1639
Email	rinri@list.waseda.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	2020 Year 10 Month 19 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	Completed
Date of protocol fixation	2020 Year 08 Month 18 Day
Date of IRB	2020 Year 10 Month 20 Day
Anticipated trial start date	2020 Year 11 Month 01 Day
Last follow-up date	2022 Year 03 Month 25 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2020 Year 10 Month 19 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/icdr_e/ctr_view.cgi?recptno=R000048123