UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000062528 |
|---|---|
| Receipt number | R000071565 |
| Scientific Title | Study on the utilization of sugarcane bagasse as a dietary fiber source in cold confections: Bioavailability of bagasse-containing ice cream in humans |
| Date of disclosure of the study information | 2026/08/09 |
| Last modified on | 2026/08/09 18:05:09 |
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Basic information
Public title
Study on bioavailability of sugarcane bagasse-containing ice cream in humans
Acronym
Bioavailability of bagasse-containing ice cream in humans
Scientific Title
Study on the utilization of sugarcane bagasse as a dietary fiber source in cold confections: Bioavailability of bagasse-containing ice cream in humans
Scientific Title:Acronym
Bioavailability of bagasse-containing ice cream in humans
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effects of a single ingestion of a cold confection (ice cream) containing sugarcane bagasse on postprandial blood glucose and insulin levels, and to assess its fermentability and utilization by gut microbiota in the large intestine (via breath hydrogen output), thereby clarifying its bioavailability and safety in humans.
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Postprandial blood glucose and insulin concentrations (at 0, 30, 60, 90, 120, 150, and 180 min post-ingestion.)
Key secondary outcomes
Breath hydrogen concentration (at 0 min and up to 14 h post-ingestion (every hour up to 8 h, and every 2 hours from 8 to 14 h, for a total of 12 times) and gastrointestinal symptoms (monitor symptoms such as nausea, abdominal pain, abdominal bloating, and bowel movement status.)
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Duration: 1 day (Single ingestion, with a washout period of at least 1 week between tests)
Test material: Plain black tea-flavored ice cream (Control)
Dose: Approx. 150 g
Administration: Ingest once in the early morning under fasting conditions.
Interventions/Control_2
Duration: 1 day (Single ingestion, with a washout period of at least 1 week between tests)
Test material: 1.5% Sugarcane bagasse-containing black tea-flavored ice cream
Dose: Approx. 150 g
Administration: Ingest once in the early morning under fasting conditions.
Interventions/Control_3
Duration: 1 day (Single ingestion, with a washout period of at least 1 week between tests)
Test material: 1.5% Cellulose-containing black tea-flavored ice cream (Positive control)
Dose: Approx. 150 g
Administration: Ingest once in the early morning under fasting conditions.
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
| 35 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Healthy Japanese adult men and women
Key exclusion criteria
The exclusion criteria are diabetes mellitus, abnormal glucose metabolism, respiratory disease, chronic gastrointestinal disease (inflammatory bowel disease, irritable bowel syndrome, functional dyspepsia, etc.), abdominal surgery, history of abnormal bowel movements, blood disorders, food allergies, or a BMI of 25.0 or higher. Smokers, individuals with excessive alcohol intake, and pregnant or lactating women will be excluded. Also excluded are those who regularly consume non-digestible and absorbable saccharides (such as dietary fiber), and those who routinely consume pharmaceuticals (such as antibiotics), foods for specified health uses, functional foods, or health foods.
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Kenichi |
| Middle name | |
| Last name | Tanabe |
Organization
Nakamura Gakuen University
Division name
Department of Nutritional Science, Faculty of Nutritional Sciences
Zip code
814-0198
Address
5-7-1 Befu, Jonan-ku, Fukuoka
TEL
092-851-2598
tanabek@nakamura-u.ac.jp
Public contact
Name of contact person
| 1st name | Kenichi |
| Middle name | |
| Last name | Tanabe |
Organization
Nakamura Gakuen University
Division name
Faculty of Nutritional Sciences
Zip code
814-0198
Address
5-7-1 Befu, Jonan-ku, Fukuoka
TEL
092-851-2598
Homepage URL
tanabek@nakamura-u.ac.jp
Sponsor or person
Institute
Nakamura Gakuen University
Institute
Department
Personal name
Funding Source
Organization
Nakamura Gakuen University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Fukuoka Institute of Technology
Name of secondary funder(s)
Fukuoka Institute of Technology
IRB Contact (For public release)
Organization
Ethical Review Committee for Research Involving Human Subjects in Nakamura Gakuen University
Address
5-7-1 Befu, Jonan-ku, Fukuoka
Tel
092-851-2598
tanabek@nakamura-u.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
中村学園大学（福岡県）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 08 | Month | 09 | 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 | 06 | Month | 29 | Day |
Date of IRB
| 2026 | Year | 08 | Month | 06 | Day |
Anticipated trial start date
| 2026 | Year | 08 | Month | 17 | Day |
Last follow-up date
| 2027 | 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
| 2026 | Year | 08 | Month | 09 | Day |
Last modified on
| 2026 | Year | 08 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071565
