UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000048577
Receipt number 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 2023/02/06 14:42:31

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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 or person

Institute

Healthcare Systems Co., Ltd.

Institute

Department

Personal name



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

20

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

Completed

Date of protocol fixation

2022 Year 08 Month 04 Day

Date of IRB

2022 Year 08 Month 04 Day

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

2023 Year 02 Month 06 Day



Link to view the page

Value
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