UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046210 |
|---|---|
| Receipt number | R000052489 |
| Scientific Title | The effects of pre-exercise different glycaemic index meals on glucose and fat metabolism, and appetite |
| Date of disclosure of the study information | 2021/11/30 |
| Last modified on | 2022/11/28 09:29:29 |
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Basic information
Public title
The effects of pre-exercise high and low glycaemic index meals on metabolism and appetite
Acronym
Effects of pre-exercise different glycaemic index meals on metabolism and appetite
Scientific Title
The effects of pre-exercise different glycaemic index meals on glucose and fat metabolism, and appetite
Scientific Title:Acronym
Effects of pre-exercise different glycaemic index meals on subsequent metabolism and appetite
Region
| Japan |
Condition
Condition
Adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to investigate the effects of pre-exercise meal with high and low glycaemic index (GI) on carbohydrate metabolism, fat metabolism, appetite-related hormones and appetite in middle-aged inactive women
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Fat oxidation
Key secondary outcomes
Expired gas, blood lipid and carbohydrate parameters, hormonal markers and food reward
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food | Other |
Interventions/Control_1
Participants consume the low GI meal and then perform walking exercise. Energy metabolism, blood lipids/carbohydrate metabolic parameters, hormonal markers and reward-driven appetite are measured and evaluated.
Interventions/Control_2
Participants consume the high GI meal and then perform walking exercise. Energy metabolism, blood lipids/carbohydrate metabolic parameters, hormonal markers and reward-driven appetite are measured and evaluated.
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
| 30 | years-old | <= |
Age-upper limit
| 59 | years-old | >= |
Gender
Female
Key inclusion criteria
1. Age between 30 and 59 years old
2. Not taking any medications and dietary supplements
3. No medical and surgical diseases
4. No smoker
5. A participant who not performed weight changes plus or minus 3 kg in the past three months and who has no intention to weight loss during the study
6. Must not be the participant of others research within the research period (confirm by asking the participants directly and orally when explaining the research content)
7. A participant who can consume the test meal in the study
8. A participant whose menstrual cycle is normal
Key exclusion criteria
1. Not age between 30 and 59 years old
2. A participant who takes medications and dietary supplements
3. A participant who has medical and surgical diseases
4. Smoker
5. A participant who performed weight changes plus or minus 3 kg in the past three months and who has an intention to weight loss during the study
6. A participant who are scheduled to participate to others research.
7. A participant who cannot consume the test meal in the study
8. A participant who is pregnant, suspected of being pregnant, and within 1 year of parturition
Target sample size
15
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
Waseda University
Organization
Division
Category of Funding Organization
Other
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
| 2021 | Year | 11 | Month | 30 | 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
| 2021 | Year | 11 | Month | 15 | Day |
Date of IRB
| 2021 | Year | 11 | Month | 22 | Day |
Anticipated trial start date
| 2021 | Year | 11 | Month | 30 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 11 | Month | 27 | Day |
Last modified on
| 2022 | Year | 11 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052489
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
