UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042157 |
|---|---|
| Receipt number | 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 | 2021/10/20 10:40:06 |
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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
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
m.miyashita@waseda.jp
Sponsor or person
Institute
Waseda University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048123
