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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000042157
Receipt No. R000048123
Scientific Title Evaluation of the effects of postprandial food intake on energy expenditure, digestion and absorption
Date of disclosure of the study information 2020/10/19
Last modified on 2021/04/20

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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 Open public recruiting
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 04 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048123

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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