UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046268 |
|---|---|
| Receipt number | R000052792 |
| Scientific Title | Evaluation of the effect of continuous intake of nuts on the functional components in blood and feces |
| Date of disclosure of the study information | 2023/04/30 |
| Last modified on | 2023/11/29 13:56:11 |
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Basic information
Public title
Evaluation of the effect of continuous intake of nuts on the functional components in blood and feces
Acronym
Evaluation of the effects of continuous intake of nuts
Scientific Title
Evaluation of the effect of continuous intake of nuts on the functional components in blood and feces
Scientific Title:Acronym
Evaluation of the effects of continuous intake of nuts
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of continuous intake of nuts on blood and fecal functional components
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
linoleic acid metabolites concentration in blood
Key secondary outcomes
linoleic acid metabolites concentration in feces
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
3 capsules of linoleic acid metabolites-containing food are taken.
After that, (1) 30 g of almonds, (2) 9 capsules of linoleic acid metabolites-containing foods, are daily taken for one week, respectively.
Interventions/Control_2
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Males and females over 20 years old
Key exclusion criteria
(1) Subjects who regularly use other health foods and drugs
(2) Subjects who are heavy drinkers or alcoholics
(3) Subjects who have a disease that requires emergency treatment, or have serious complications
(4) Subjects who have a medical history of digestive diseases or surgeries affecting digestion and absorption
(5) Subjects who are pregnant or plan to become pregnant, or breast-feeding during the study
(6) Subjects who are participating in other clinical trials that intake/apply any foods or drugs
(7) Subjects who do not meet the specimen acceptance criteria set by the company
Target sample size
8
Research contact person
Name of lead principal investigator
| 1st name | Yasuo |
| Middle name | |
| Last name | Saito |
Organization
Ezaki Glico Co., Ltd.
Division name
R&D Laboratory
Zip code
555-8502
Address
4-6-5 Utajima, Nishiyodogawa-ku, Osaka 555-8502, Japan
TEL
05017466514
yasuo.saito@glico.com
Public contact
Name of contact person
| 1st name | Natsumi |
| Middle name | |
| Last name | Wada |
Organization
Ezaki Glico Co., Ltd.
Division name
R&D Laboratory
Zip code
555-8502
Address
4-6-5 Utajima, Nishiyodogawa-ku, Osaka 555-8502, Japan
TEL
05017496432
Homepage URL
natsumi.wada@glico.com
Sponsor or person
Institute
Ezaki Glico Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Ezaki Glico Co., Ltd.
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
The Institutional Review Board of Glico Group
Address
4-6-5 Utajima, Nishiyodogawa-ku, Osaka 555-8502, Japan
Tel
05017454027
toshihiko.koike@glico.com
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
| 2023 | Year | 04 | Month | 30 | Day |
Related information
URL releasing protocol
https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000052792
Publication of results
Unpublished
Result
URL related to results and publications
https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000052792
Number of participants that the trial has enrolled
8
Results
Concentrations of linoleic acid metabolites were elevated in feces compared to baseline in some individuals with continued consumption of almonds, although not statistically significant. In contrast, no linoleic acid metabolites were detected in blood.
Results date posted
| 2023 | Year | 11 | Month | 29 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
linoleic acid metabolites concentration in blood
linoleic acid metabolites concentration in feces
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2021 | Year | 11 | Month | 09 | Day |
Date of IRB
| 2021 | Year | 11 | Month | 09 | Day |
Anticipated trial start date
| 2021 | Year | 12 | Month | 04 | Day |
Last follow-up date
| 2023 | Year | 11 | Month | 20 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 12 | Month | 03 | Day |
Last modified on
| 2023 | Year | 11 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052792
