UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046334 |
|---|---|
| Receipt number | R000052863 |
| Scientific Title | Effect of breakfast skipping on endothelial function, glycemic response and gastric emptying in the morning and early afternoon |
| Date of disclosure of the study information | 2021/12/20 |
| Last modified on | 2024/12/16 15:24:44 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Effect of breakfast skipping on endothelial function, glycemic response and gastric emptying in the morning and early afternoon
Acronym
Effect of breakfast skipping on endothelial function, glycemic response and gastric emptying in the morning and early afternoon
Scientific Title
Effect of breakfast skipping on endothelial function, glycemic response and gastric emptying in the morning and early afternoon
Scientific Title:Acronym
Effect of breakfast skipping on endothelial function, glycemic response and gastric emptying in the morning and early afternoon
Region
| Japan |
Condition
Condition
Adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Breakfast skipping is a risk factor for cardiovascular diseases, including atherosclerosis.However, it is possible that many complex and unmeasured confounding factors contribute to deciphering these data. Thus, we need to investigate whether breakfast skipping itself is causally related to cardiovascular disease outcomes [e.g. vascular endothelial function (VEF) which is a biomarker of cardiovascular disease]. The objective of the present study was to investigate the effects of breakfast skipping on brachial artery VEF in the morning (before lunch) and afternoon (after lunch) in healthy subjects with a breakfast habit.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
endothelial function
Key secondary outcomes
Blood glucose, plasma insulin, plasma free fatty acids, plasma triglycerides, blood pressure, heart rate, brachial artery blood flow velocity, brachial artery vascular diameter,
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 | Behavior,custom | Other |
Interventions/Control_1
Participants consume a breakfast meal at 8:30-9:00, and subsequently consume lunch meal at 12:00-12:30 and rest for 3 hours (at 15:30). Endothelial function in brachial artery is evaluated using flow mediated dilation (FMD) method by ultrasonography at 8:00 (baseline), 10:00, 12:00, 13:30 and 15:30. FMD is calculated as percent change of diameter (%FMD) and also normalized for shear rate (SR) (%FMDSRauc). Blood glucose and plasma insulin levels are measured before and after breakfast and lunch time. Gastric emptying rate is evaluated using 13C breath test.
Interventions/Control_2
Participants skip a breakfast meal at 8:30-9:00, and subsequently consume lunch meal at 12:00-12:30 and rest for 3 hours (at 15:30). Endothelial function in brachial artery is evaluated using flow mediated dilation (FMD) method by ultrasonography at 8:00 (baseline), 10:00, 12:00, 13:30 and 15:30. FMD is calculated as percent change of diameter (%FMD) and also normalized for shear rate (SR) (%FMDSRauc). Blood glucose and plasma insulin levels are measured before and after breakfast and lunch time. Gastric emptying rate is evaluated using 13C breath test.
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
| 18 | years-old | <= |
Age-upper limit
| 59 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Age between 20 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 20 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 | Hideaki |
| Middle name | |
| Last name | Kashima |
Organization
Prefectural University of Hiroshima
Division name
Faculty of Health Sciences
Zip code
734-8558
Address
1-1-71 Ujina-higashi, Minami-ku, Hiroshima
TEL
082-251-9806
h-kashima@pu-hiroshima.ac.jp
Public contact
Name of contact person
| 1st name | Hideaki |
| Middle name | |
| Last name | Kashima |
Organization
Prefectural University of Hiroshima
Division name
Faculty of Health Sciences
Zip code
734-8558
Address
1-1-71 Ujina-higashi, Minami-ku, Hiroshima
TEL
082-251-9806
Homepage URL
h-kashima@pu-hiroshima.ac.jp
Sponsor or person
Institute
Prefectural University of Hiroshima
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science KAKENHI
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Prefectural University of Hiroshima
Address
1-1-71 Ujina-higashi, Minami-ku, Hiroshima
Tel
0822519534
kikaku2@pu-hiroshima.ac.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 | 12 | Month | 20 | 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
10
Results
Vascular endothelial function was significantly increased in eating breakfast condition early after consumption of lunch compared with baseline (P < 0.05), but it did not change in Skipping breakfast condition.
Results date posted
| 2022 | Year | 12 | Month | 10 | Day |
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 | 03 | Month | 22 | Day |
Date of IRB
| 2021 | Year | 03 | Month | 22 | Day |
Anticipated trial start date
| 2021 | Year | 12 | Month | 20 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2023 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2024 | Year | 02 | Month | 28 | Day |
Date analysis concluded
| 2024 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2021 | Year | 12 | Month | 09 | Day |
Last modified on
| 2024 | Year | 12 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052863
