UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049363 |
|---|---|
| Receipt number | R000056217 |
| Scientific Title | Effect of additional fruit granola intake for breakfast on physical status |
| Date of disclosure of the study information | 2022/10/29 |
| Last modified on | 2024/04/06 21:08:56 |
* 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 additional fruit granola intake for breakfast on physical status
Acronym
Effect of additional fruit granola intake for breakfast on physical status
Scientific Title
Effect of additional fruit granola intake for breakfast on physical status
Scientific Title:Acronym
Effect of additional fruit granola intake for breakfast on physical status
Region
| Japan |
Condition
Condition
Healthy Children
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effects of additional fruit granola intake for breakfast on waking and sleeping times, defecation, and breakfast nutritional balance.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
sleep index
Key secondary outcomes
Defecation, nutritional balance of breakfast
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Add to eat fruit granola at breakfast
Interventions/Control_2
Not to eat fruit granola at breakfast
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
| 6 | years-old | <= |
Age-upper limit
| 12 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Healthy children between the ages of 6-12
2. Parental or guardian's consent in writing
Key exclusion criteria
1.Those who are currently undergoing treatment for a medical condition
2.Those who are currently taking medication under the direction of a physician.
3.You are planning to receive medical treatment during the study period.
4.Have any of the following food allergies (milk, wheat, almond, soybean, gelatin)
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Akiko |
| Middle name | |
| Last name | Furutani |
Organization
Aikoku Gakuen Junior College
Division name
Department of Home Economics
Zip code
1338585
Address
5-7-1, Nishikoiwa, Edogawa-ku, Tokyo
TEL
03-5668-7260
furutani@aikoku-jc.ac.jp
Public contact
Name of contact person
| 1st name | Akiko |
| Middle name | |
| Last name | Furutani |
Organization
Aikoku Gakuen Junior College
Division name
Department of Home Economics
Zip code
1338585
Address
5-7-1, Nishikoiwa, Edogawa-ku, Tokyo
TEL
03-5668-7260
Homepage URL
a.furutani@kurenai.waseda.jp
Sponsor or person
Institute
Aikoku Gakuen Junior College
Institute
Department
Personal name
Funding Source
Organization
Calbee, Inc.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Waseda University, Research Organization for Nano and Life Innovation
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Aikoku Gakuen Junior College
Address
5-7-1, Nishikoiwa, Edogawa-ku, Tokyo
Tel
03-5668-7260
aioffice@aikoku-jc.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
| 2022 | Year | 10 | Month | 29 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://www.mdpi.com/2227-9067/10/5/779
Number of participants that the trial has enrolled
26
Results
The additional consumption of granola snacks increased the breakfast intake of 15 nutrients.
The changes were particularly significant increased for iron, vitamin B1, vitamin D, and dietary fiber.
During the intervention, bed in time was not chenged, wake-up time became earlier about 15 minutes
In terms of defecation, the intervention did not change stool characteristics, but the frequency of defecations per week increased on average by 1.2 per week.
Results date posted
| 2024 | Year | 04 | Month | 06 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
No adverse events were reported.
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2022 | Year | 10 | Month | 28 | Day |
Date of IRB
| 2022 | Year | 10 | Month | 01 | Day |
Anticipated trial start date
| 2022 | Year | 10 | Month | 28 | Day |
Last follow-up date
| 2023 | Year | 12 | 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
| 2022 | Year | 10 | Month | 28 | Day |
Last modified on
| 2024 | Year | 04 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056217
