UMIN-CTR Clinical Trial

Public title

Effects of Combination of Consuming the Test Food and Mild Exercise on Physical Performance (Mobility Function) in Healthy Middle-Aged and Older Adults.

Acronym

Effects of Combination of Consuming the Test Food and Mild Exercise on Physical Performance (Mobility Function) in Healthy Middle-Aged and Older Adults.

Scientific Title

Effects of Combination of Consuming the Test Food and Mild Exercise on Physical Performance (Mobility Function) in Healthy Middle-Aged and Older Adults.

Scientific Title:Acronym

Effects of Combination of Consuming the Test Food and Mild Exercise on Physical Performance (Mobility Function) in Healthy Middle-Aged and Older Adults.

Region

Japan

Condition

No

Classification by specialty

Not applicable

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

This study aims to examine effects of combination of consuming the test food and mild exercise on physical performance (mobility function) in healthy middle-aged and older adults.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Motor function related indexes.
･Knee extension muscular strength measurement.
･Five times sit to stand test
(Screening, Week 0, Week 4, Week 8, Week 12).

Key secondary outcomes

*Secondary indexes
QOL related index.
･SF-36v2 Japanese version (Acute version)(1).

*Safety
[1] Hematologic test (2)
[2] Blood biochemical test (2)
[3] Urine analysis (2)
[4] Blood pressure, pulsation (1)
[5] Weight, body fat percentage, BMI(1)
[6] Doctor's questions/ Adverse events (1)
[7] Subject's diary (3)

*Other indexes
[1] Baseline characteristics(4)
[2] Height measurement(4)
[3] Electrocardiogram (4)

(1): Screening, Week 0, Week 4, Week8, Week 12
(2): Screening, Week 0, Week8, Week 12
(3): From the first day of ingestion of a test material to the last day of the test
(4): Screening

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

Oral intake of the test product (1 packet (3 g), 3 times a day: 12 weeks) and exercise (Once every 2 days: 12 weeks).

Interventions/Control_2

Oral intake of the placebo product (1 packet (3 g), 3 times a day: 12 weeks)and exercise (Once every 2 days: 12 weeks).

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

50

years-old

<=

Age-upper limit

60

years-old

>

Gender

Male and Female

Key inclusion criteria

[1] Healthy Japanese males and females aged 50-59 years.
[2] Individuals who are healthy and have no chronic physical disease.
[3] Individuals who do not have a habit of exercising regularly and feel the motor functional decline.
[4] Individuals whose written informed consent has been obtained after explanation of this study.
[5] Individuals who can have an examination on a designated check day.
[6] Individuals who are judged appropriate for the study by the principal.

Key exclusion criteria

[1] Individuals who may develop allergic symptoms to yams
[2] Individuals who have difficulty in performing the designated exercise at home during the test period.
[3] Individuals using medical products.
[4] Individuals who are patient or have a history of psychiatric disease, high blood pressure, diabetes, and hyperlipidemia.
[5] Individuals who have a history of serious hepatopathy, kidney damage, heart disease, hematological and blood disease.
[6] Individuals who contract or have a history of serious endocrine disease.
[7] Individuals with a history or current medical history of cardiac disease, or with abnormalities in electrocardiogram tests.
[8] Individuals who are patient or have a history of psychiatric disease, high blood pressure, diabetes, and hyperlipidemia.
[9] Individuals who are sensitive to foods, and medical products.
[10] Individuals whose BMI is over 30 kg/m2.
[11] Individuals who donated blood over 200mL in the past 1 month or over 400mL in the past 3 months.
[12] Individuals who have a habit of continuous intake of functional foods, health foods, supplements, and beverages (excepting individuals who can suspend intake for a period of time at obtaining informed consent.), and who plan to consume such foods during the test period.
[13] Individuals who are salespeople or often work outside the office with exercise habits.
[14] Individuals who are alcoholism or excessively take alcohol (expressed in an amount of alcohol: over 60g/day).
[15] Individuals who are likely to undergo a significant change in lifestyle, such as long-term business trips or travel during the research period.
[16] Individuals who are or are possibly, or are lactating.
[17] Individuals who participated in other clinical studies in the past 3 months.
[18] Individuals who are or whose family is engaged in health foods of functional foods.
[19] Individuals judged inappropriate for the study by the principal.

Target sample size

80

Name of lead principal investigator

1st name	Atsushi
Middle name
Last name	Nakajima

Organization

Ueno-Asagao Clinic

Division name

Head

Zip code

110-0015

Address

6F Kairaku Building 2-7-5 Higashiueno Taito-ku Tokyo 110-0015, JAPAN

TEL

+81-3-6240-1162

Email

info@ueno-asagao.clinc

Name of contact person

1st name	Ryoma
Middle name
Last name	Shimizu

Organization

TES Holdings Co., Ltd.

Division name

Administrative Department of Clinical Trials

Zip code

110-0015

Address

6F Kairaku Building 2-7-5 Higashiueno Taito-ku Tokyo 110-0015, JAPAN

TEL

+81-3-6801-8480

Homepage URL

Email

r.shimizu@tes-h.co.jp

Institute

TES Holdings Co., Ltd.

Institute

Department

Personal name

Organization

Otsuka Pharmaceutical Factory, Inc.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Ueno-Asagao Clinic Ethical Review Committee

Address

6F Kairaku Building 2-7-5 Higashiueno Taito-ku Tokyo 110-0015, JAPAN

Tel

+81-3-6240-1162

Email

i.takahashi@tes-h.co.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2024

Year

08

Month

16

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Completed

Date of protocol fixation

2023

Year

07

Month

26

Day

Date of IRB

2023

Year

07

Month

27

Day

Anticipated trial start date

2023

Year

08

Month

30

Day

Last follow-up date

2023

Year

11

Month

30

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2023

Year

08

Month

10

Day

Last modified on

2024

Year

02

Month

22

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059048