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Name
UMIN ID

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000048577
Receipt No. R000055355
Scientific Title An exploratory study on the effects of continuous intake of almond meal on health conditions
Date of disclosure of the study information 2022/08/04
Last modified on 2022/08/04

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Basic information
Public title An exploratory study on the effects of continuous intake of almond meal on health conditions
Acronym An exploratory study on the effects of continuous intake of almond meal on health conditions
Scientific Title An exploratory study on the effects of continuous intake of almond meal on health conditions
Scientific Title:Acronym An exploratory study on the effects of continuous intake of almond meal on health conditions
Region
Japan

Condition
Condition Healthy Adults
Classification by specialty
Not applicable
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To assess the health effects of two-week consumption of almond meal
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Intestinal environment (urinary indoxyl sulfate, urinary creatinine) before and after ingestion
Key secondary outcomes Oxidative stress level(urinary 8-OHdG, urinary creatinine)
Protein adequacy test (urinary urea nitrogen, urinary creatinine)
Immune test (IgA in saliva)
before and after ingestion

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 Consume 20 g of almond meal daily for 2 weeks
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
65 years-old >
Gender Male and Female
Key inclusion criteria 1. Persons who received a sufficient explanation of the purpose and contents of the exam, have the capacity to consent, applied with free will with sufficient understanding, and agreed to participate with a written document
2. Healthy Japanese who are 20 years old or more and under 65 years old
Key exclusion criteria 1. Persons who have chronic illness, receiving medication, have a serious disease history
2. Persons who are allergic to the test food or almond
3. Persons who regularly take a large amount of test food or almonds
4. Persons who regularly take medicines or foods with health claims that may affect the intestinal environment, immunity, and antioxidant effects, or nutritional supplements to supplement proteins.
5. Persons who have participated in other tests within the first month before the start of the test, or those who intend to participate in another exam after consenting to this exam
6. Persons who were judged as inappropriate for study participants by the principal investigator
7. Persons who are pregnant, planning or hoping to be pregnant during the study period, breastfeeding
Target sample size 20

Research contact person
Name of lead principal investigator
1st name Yoshikatsu
Middle name
Last name Hosoya
Organization Healthcare Systems Co., Ltd.
Division name Sales Planning Department
Zip code 105-0004
Address Nisshin Tatemono Shinbashi Bld. 7F, 4-6-15 Shinbashi, Minato-ku, Tokyo, JAPAN
TEL 03-6809-2722
Email hosoya@hc-sys.jp

Public contact
Name of contact person
1st name Yoshikatsu
Middle name
Last name Hosoya
Organization Healthcare Systems Co., Ltd.
Division name Sales Planning Department
Zip code 105-0004
Address Nisshin Tatemono Shinbashi Bld. 7F, 4-6-15 Shinbashi, Minato-ku, Tokyo, JAPAN
TEL 03-6809-2722
Homepage URL
Email hosoya@hc-sys.jp

Sponsor
Institute Healthcare Systems Co., Ltd.
Institute
Department

Funding Source
Organization Ota Oil 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 Ethics Committee of Healthcare Systems Co., Ltd.
Address 1-14-18 Shirakane, Showa-ku, Nagoya city, Aichi, JAPAN
Tel 052-734-8885
Email soumu@hc-sys.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 08 Month 04 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
2022 Year 08 Month 04 Day
Date of IRB
Anticipated trial start date
2022 Year 08 Month 05 Day
Last follow-up date
2022 Year 08 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 08 Month 04 Day
Last modified on
2022 Year 08 Month 04 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055355

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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