UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059121 |
|---|---|
| Receipt number | R000067630 |
| Scientific Title | The inhibitory effect of NVIF2025-01 intake on fructose absorption |
| Date of disclosure of the study information | 2025/09/23 |
| Last modified on | 2025/09/18 11:57:21 |
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Basic information
Public title
The inhibitory effect of NVIF2025-01 intake on fructose absorption
Acronym
The inhibitory effect of NVIF2025-01 intake on fructose absorption
Scientific Title
The inhibitory effect of NVIF2025-01 intake on fructose absorption
Scientific Title:Acronym
The inhibitory effect of NVIF2025-01 intake on fructose absorption
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of NVIF2025-01 in suppressing the elevation of postprandial blood fructose concentration.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Postprandial blood fructose dynamics
Key secondary outcomes
None
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Placebo drink (a single time intake) -> Washout (not less than 1 week) -> Test drink, containing NVIF2025-01 (a single time intake)
Interventions/Control_2
Test drink, containing NVIF2025-01 (a single time intake) -> Washout (not less than 1 week) -> Placebo drink (a single time intake)
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
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Male and female employees of Nagase Vita Co., Ltd. aged 18 to 65 who have been employed for over one year.
2) Those who do not work in shifts for the convenience of subject management.
3) Those who do not smoke or consume excessive alcohol.
4) Those who are not pregnant, may not be pregnant, or are not breastfeeding during the trial period.
5) Those who have no history of conditions or medications that could affect the trial.
6) Those who have never been diagnosed with impaired glucose tolerance or dyslipidemia.
7) Those whose liver function and blood glucose test values from their most recent health checkup are within normal ranges.
8) BMI (Body Mass Index) is included between 18.5 to less than 30.
9) Those who do not experience regular abdominal discomfort.
10) Those who have no allergies to the provided foods.
11) Those who are comfortable with consuming sweet beverages.
12) Those who are considered suitable for participation by the investigator.
Key exclusion criteria
Those who are judged inappropriate for the study by the investigator.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Yu |
| Middle name | |
| Last name | Oka |
Organization
Nagase Viita Co., Ltd.
Division name
Research, Technology & Value Creation Division, Product Value Creation Department
Zip code
702-8006
Address
675-1, Fujisaki, Naka-ku, Okayama
TEL
0862763141
yu.oka@nagase.co.jp
Public contact
Name of contact person
| 1st name | Yu |
| Middle name | |
| Last name | Oka |
Organization
Nagase Viita Co., Ltd.
Division name
Research, Technology & Value Creation Division, Product Value Creation Department
Zip code
702-8006
Address
675-1, Fujisaki, Naka-ku, Okayama
TEL
0862763141
Homepage URL
yu.oka@nagase.co.jp
Sponsor or person
Institute
Nagase Viita Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Ethics Committee of Nagase Viita Co., Ltd.
Address
675-1, Fujisaki, Naka-ku, Okayama
Tel
0862763141
NVI800014@nagase.co.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
ナガセヴィータ株式会社（岡山県）/ Nagase Viita Co., Ltd.（Okayama）
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 09 | Month | 23 | 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
| 2025 | Year | 04 | Month | 21 | Day |
Date of IRB
| 2025 | Year | 04 | Month | 21 | Day |
Anticipated trial start date
| 2025 | Year | 09 | Month | 24 | Day |
Last follow-up date
| 2025 | 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
| 2025 | Year | 09 | Month | 18 | Day |
Last modified on
| 2025 | Year | 09 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067630
