UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000041066
Receipt number R000046902
Scientific Title Verification of the usefulness of food material intake for physical deterioration caused by aging -Randomized double-blind parallel group comparison method-
Date of disclosure of the study information 2020/07/13
Last modified on 2022/01/27 09:26:38

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Basic information

Public title

Verification of the usefulness of food material intake for physical deterioration caused by aging

Acronym

Verification of the usefulness of food material intake for physical deterioration caused by aging

Scientific Title

Verification of the usefulness of food material intake for physical deterioration caused by aging
-Randomized double-blind parallel group comparison method-

Scientific Title:Acronym

Verification of the usefulness of food material intake for physical deterioration caused by aging
-Randomized double-blind parallel group comparison method-

Region

Japan


Condition

Condition

Healthy

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

This study verifies efficacy in improving physical fitness

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

muscle function

Key secondary outcomes

Physical fitness indices, Muscle indices, Questionnaire about QOL and feelings


Base

Study type

Interventional


Study design

Basic design

Parallel

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

(1)Take test food once a day for 12 weeks
(2) Participate in four exercise classes
(3) Perform resistance exercise at home for 5 days a week

Interventions/Control_2

(1) Take placebo once a day for 12 weeks
(2) Participate in four exercise classes
(3) Perform resistance exercise at home for 5 days a week

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

50 years-old <=

Age-upper limit

69 years-old >=

Gender

Male and Female

Key inclusion criteria

(1) Men and women between the ages of 50 and 69 with reduced muscle quality
(2) 5 days a week during the test period, who can perform resistance exercise by own weight for 10 to 15 minutes at home
(3) Subjects who have received a sufficient explanation of the purpose and contents of the examination, have the ability to consent, have well understood, volunteered to participate, and have signed the informed consent document

Key exclusion criteria

(1) Subjects who meet the sarcopenia criteria
(2) Subjects who take more protein than necessary
(3) Subjects whose physical activity level is too high
(4) Subjects who regularly use medicines that may affect muscle and lipid metabolism and amino acid preparations
(5) Subjects who cannot stop taking supplements and health foods (including foods for specified health uses and foods with functional claims)
(6) Screening test, subjects unable to quit drinking 2 days before each test
(7) Subjects with a history of drug dependence or alcohol dependence or current medical history
(8) Subjects who participated in tests that use other foods and pharmaceuticals, tests that apply cosmetics and pharmaceuticals, etc. within 1 month from the time of obtaining consent, and subjects who participate in other tests while participating in this study
(9) Subjects with systolic blood pressure of 160 mmHg or more at screening test or diastolic blood pressure of 100 mmHg or more
(10) Subjects suffering from serious kidney disease, digestive system disease, heart disease, respiratory system disease, endocrine disease or other metabolic diseases, or subjects under treatment
(11) Subjects with physical disabilities such as severe low back pain and knee pain, which interfere with exercise
(12) Subjects with a history of orthopedic surgery that interferes with movements such as the waist and knees
(13) Subjects with metal implants such as pacemakers and bolts
(14) Subjects with difficulty measuring muscle mass and muscle quality
(15) Subjects whose exercise is prohibited by doctors
(16) Subjects who are judged as unsuitable for the study by the investigators

Target sample size

40


Research contact person

Name of lead principal investigator

1st name Tomoyuki
Middle name
Last name Mine

Organization

Ajinomoto Co., Inc.

Division name

Human Health & Nutrition Group, Institute of Food Sciences and Technologies

Zip code

210-8681

Address

1-1, Suzuki-cho, Kawasaki-ku, Kawasaki-shi, Kanagawa

TEL

044-223-4114

Email

tomoyuki_mine@ajinomoto.com


Public contact

Name of contact person

1st name Ryo
Middle name
Last name Uchida

Organization

Ajinomoto Co., Inc.

Division name

Human Health & Nutrition Group, Institute of Food Sciences and Technologies

Zip code

210-8681

Address

1-1, Suzuki-cho, Kawasaki-ku, Kawasaki-shi, Kanagawa

TEL

044-223-4114

Homepage URL


Email

ryo_uchida@ajinomoto.com


Sponsor or person

Institute

KSO Corporation

Institute

Department

Personal name



Funding Source

Organization

Ajinomoto Co., Inc

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization



Other related organizations

Co-sponsor

KSO Corporation

Name of secondary funder(s)



IRB Contact (For public release)

Organization

Ethical Committee of Nihonbashi Cardiology Clinic

Address

Kyodo Bldg. #201, 13 - 4 Nihonbashi Kodenmacho, Chuo-ku, Tokyo

Tel

03-5641-4133

Email

niho-jimucho@well-sleep.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

医療法人財団健康睡眠会 日本橋循環器科クリニック(東京都)


Other administrative information

Date of disclosure of the study information

2020 Year 07 Month 13 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

Completed

Date of protocol fixation

2020 Year 07 Month 09 Day

Date of IRB

2020 Year 07 Month 09 Day

Anticipated trial start date

2020 Year 08 Month 21 Day

Last follow-up date

2020 Year 12 Month 19 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2020 Year 07 Month 10 Day

Last modified on

2022 Year 01 Month 27 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046902


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name