UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062919 |
|---|---|
| Receipt number | R000072037 |
| Scientific Title | Effects of Consuming Calcium-Fortified Granola at Breakfast on Glucose Tolerance and Lipid Metabolism Indicators (TG/HDL Ratio) in Japanese Adults: An Open-Label, Randomized, Parallel-Group Comparative Trial |
| Date of disclosure of the study information | 2026/09/15 |
| Last modified on | 2026/09/14 16:38:15 |
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Basic information
Public title
Preliminary Investigation of the Effects of a Calcium-Fortified Breakfast on Glucose Tolerance and Lipid Metabolism Indicators (TG/HDL Ratio) in Japanese Adults
Acronym
Preliminary Investigation of the Effects of a Calcium-Fortified Breakfast on Glucose Tolerance and Lipid Metabolism Indicators (TG/HDL Ratio) in Japanese Adults
Scientific Title
Effects of Consuming Calcium-Fortified Granola at Breakfast on Glucose Tolerance and Lipid Metabolism Indicators (TG/HDL Ratio) in Japanese Adults: An Open-Label, Randomized, Parallel-Group Comparative Trial
Scientific Title:Acronym
Effects of Consuming Calcium-Fortified Granola at Breakfast on Glucose Tolerance and Lipid Metabolism Indicators (TG/HDL Ratio) in Japanese Adults: An Open-Label, Randomized, Parallel-Group Comparative Trial
Region
| Japan |
Condition
Condition
Healthy Adults
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate, through a randomized parallel-group comparative trial, the effects of continued consumption of calcium-fortified granola and milk as breakfast on glycemic indicators (fasting blood glucose and HbA1c) and lipid metabolism indicators (TG, LDL-C, HDL-C, and the TG/HDL ratio) in healthy Japanese adults.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Glucose Tolerance Related Parameters
Key secondary outcomes
Lipid metabolism
Blood pressure
Continuous glucose monitoring
Gut microbiota
Bowel habits
Subjective sleep assessment
Feeling of restfulness after sleep
Mood state
Body composition
Base
Study type
Interventional
Study design
Basic design
Parallel
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
3
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Eat Consuming Calcium Fortified Granola at breakfast
Interventions/Control_2
Eat Granola at breakfast
Interventions/Control_3
Consume their usual breakfast
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
| 19 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Healthy Japanese adults
2. Age: 19 to 65 years
3. BMI: 20 to 30 kg/m2
4. Individuals who skip breakfast or consume only about 100 kcal for breakfast. 5. Individuals who fully understand the study procedures and provide written informed consent
Key exclusion criteria
1. Individuals currently receiving treatment for lifestyle-related diseases, such as diabetes mellitus, dyslipidemia, or hypertension
2. Individuals who regularly use calcium preparations, supplements, or similar products
3. Individuals with allergies to dairy products, wheat, or any ingredients contained in granola
4. Individuals with skin conditions, eczema, or similar conditions at the sensor application site (the back of the upper arm), or those with severe allergies to adhesives such as those used in adhesive bandages
5. Pregnant or breastfeeding individuals
6. Individuals deemed unsuitable for participation by the principal investigator or the study physician
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
133-0057
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
133-0057
Address
5-7-1, Nishikoiwa, Edogawa-ku, Tokyo
TEL
03-5668-7260
Homepage URL
furutani@aikoku-jc.ac.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
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
| 2026 | Year | 09 | Month | 15 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 09 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 09 | Month | 16 | Day |
Last follow-up date
| 2026 | 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
| 2026 | Year | 09 | Month | 14 | Day |
Last modified on
| 2026 | Year | 09 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072037
