UMIN-CTR Clinical Trial

Public title

A study of milk-derived components on physical functions

Acronym

A study of milk-derived components on physical functions

Scientific Title

A study of milk-derived components on physical functions

Scientific Title:Acronym

A study of milk-derived components on physical functions

Region

Japan

Condition

Healthy Adult

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To investigate the effects on physical functions of milk-derived components ingestion for 8 weeks.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Developmental phase

Not applicable

Primary outcomes

Change in the physical function (stepping (sitting position)) caused by the ingestion of test food.

Key secondary outcomes

Change in the physical functions (10-meter walk, 10-m walk with obstacle crossing, chair stand (CS-30), and foot balance with eyes opened), realization of physical functions, thigh circumference, blood biochemistry, and daily life caused by the ingestion of test food.

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

YES

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

No need to know

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Food	Behavior,custom

Interventions/Control_1

Ingestion of milk-derived components each day and light exercise (2 times per week) for 8 weeks.

Interventions/Control_2

Ingestion of placebo each day and light exercise (2 times per week) for 8 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

70

years-old

>

Gender

Male and Female

Key inclusion criteria

1) Those who satisfy the entry criteria for this test in questionnaire survey at the time of subject requirement.
2) Healthy male and female who are 50 years old and more and less than 70 years old at the time of acquiring consent.
3) Those who can continuously take test foods from May 2016 to September 2016 and participate in the test including blood collection and exercise.

Key exclusion criteria

1) Those who currently have diseases and get treatment and/or medication continuously.
2) Those who are expected to receive doctor's prescription during the test period.
3) Those who have such serious diseases in liver, kidney, heart, lung, digestive organ, blood, endocrine system, and metabolism.
4) Those who have food allergy against milk-related foods.
5) Those who take milk foods excessively (Average 500 mL per day and more)
6) Athlete and training coach
7) Those who are advised by a doctor to stop exercise.
8) Those who have had such serious damages to moving organs such as bone breakage, ruptured tendon and tone muscle within 1 year .
9) Those who have chronic pain in the lower back or knee.
10) Those who take supplements which have claimed to influence to exercise functions (protein, amino acid, etc.) during the last 1 month.
11) Those who have had bad feeling after blood collection.
12) Those who have systolic blood pressure below 90 mmHg or more than 150 mmHg.
13) Those who are in pregnancy (including its possibility) or lactation period.
14) Those male person who donated 400ml of whole blood in 3 months of period before the start of test.
15) Those female person who donated 400ml of whole blood in 4 months of period before the start of test.
16) Those who had full score on "physical functioning" or "daily roll functioning (physical)" of SF-36 in the screening.
17) Those who have the following result of stepping (sitting position) in the screening.
Age 50-54:(M) more than 95 times/10sec,(F)more than 83 times/10sec.
Age 55-59:(M) more than 91 times/10sec,(F)more than 82 times/10sec.
Age 60-64:(M) more than 84 times/10sec,(F)more than 78 times/10sec.
Age 65-69:(M) more than 75 times/10sec,(F)more than 62 times/10sec.
18) Those who are taking part in other tests or who took part in other test no later than 4 weeks.
19) Those who are judged as inappropriate for the subject of this test by any of the doctor in charge of this test.

Target sample size

60

Name of lead principal investigator

1st name
Middle name
Last name	Junichi Hayashi

Organization

Shintoshin Juni-so Clinic

Division name

Head Office

Zip code

Address

2F Concieria Nishi-shinjuku Tower's West, 6-20-7 Nishi-shinjuku Shinjuku-ku Tokyo JAPAN

TEL

03-5323-3032

Email

info@keijunkai.or.jp

Name of contact person

1st name
Middle name
Last name	Shogo Ide

Organization

Sense It Smart Corporation

Division name

Evidence Department

Zip code

Address

K-WING 9F 5-2-1 Kojimachi Chiyoda-ku Tokyo JAPAN

TEL

03-5276-2277

Homepage URL

Email

contact@senseitsmart.com

Institute

Sense It Smart Corporation

Institute

Department

Personal name

Organization

Kao Corporation

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

新都心十二社クリニック、新宿区内会議室（身体機能試験）/ Shintoshin Juni-so Clinic and the conference rooms in Shinjuku-ku (test of physical functions)

Date of disclosure of the study information

2016

Year

06

Month

01

Day

URL releasing protocol

Publication of results

Published

URL related to results and publications

Number of participants that the trial has enrolled

Results

Abstract:
Objectives We investigated changes in physical functions (i.e., agility, balance, strength, and gait) of healthy middle-aged adults consuming milk-derived milk-fat globule membrane (MFGM) containing sphingomyelin.
Methods A randomized, double-blind, placebo-controlled study was conducted with 56 healthy middle-aged adults (age range 50-69 years). The subjects were asked to consume either MFGM tablets (MGFM containing 33 mg of sphingomyelin, 1 g/day) or placebo tablets (whole milk powder, 1 g/day) during the 8-week study period and to participate in a light exercise program (3-3.5 Mets) for 30 min twice a week. Physical performance (10-sec step counts, one-leg standing duration, and chair stand counts) and walking performance (10-m walking speed and obstacle walking speed), and questionnaires (MOS 36-Item Short-Form Health Survey [SF-36] and "Daily life physical function questionnaire") were evaluated.
Results In the MFGM group, changes from week 0 to week 8 of 10-sec step counts, one-leg standing duration, chair stand counts, 10-m walking speed, and obstacle walking speed were significantly improved. Improvement of obstacle walking speed and one-leg standing duration were significantly different between MFGM group and placebo group. These findings suggest that MFGM ingestion leads to better balance and faster walking time. Findings from the questionnaire suggest that subjects in the MFGM group noticed the improvements in physical and walking function (especially walking and stair-climbing performance).
Conclusion MFGM containing sphingomyelin improved physical balance and walking function of healthy middle-aged adults. Thus, MFGM may be helpful for improving locomotive syndrome.
Key words: Agility, Balance, Gait, Milk-fat globule membrane, Physical function, Sphingomyelin, Walking

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

2016

Year

04

Month

18

Day

Date of IRB

Anticipated trial start date

2016

Year

05

Month

02

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

2016

Year

10

Month

12

Day

Date analysis concluded

Other related information

Jpn Pharmacol Ther vol.45 no.2 2017
Title: Physical Performance of Healthy Middle-aged Adults Improved by Milk-fat Globule Membrane Containing Sphingomyelin Derived from Milk
- A Randomized, Double-blind, Placebo-controlled Study -
Author: Kotomi Ishimaru, Yoshiko Yanagisawa, Ryuji Ochiai, Noriko Osaki, Jyunichi Hayashi, and Yoshihisa Katsuragi

Registered date

2016

Year

04

Month

28

Day

Last modified on

2017

Year

03

Month

21

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025506