UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000035718
Receipt number R000040691
Scientific Title Intervention study on intake of Alaska pollack soup for sarcopenia prevention in community-dwelling elderly
Date of disclosure of the study information 2019/04/01
Last modified on 2022/10/25 15:09:25

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Basic information

Public title

Intervention study on intake of Alaska pollack soup for sarcopenia prevention in community-dwelling elderly

Acronym

Intervention study of Alaska pollack soup for sarcopenia prevention

Scientific Title

Intervention study on intake of Alaska pollack soup for sarcopenia prevention in community-dwelling elderly

Scientific Title:Acronym

Intervention study of Alaska pollack soup for sarcopenia prevention

Region

Japan


Condition

Condition

Sarcopenia

Classification by specialty

Geriatrics Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

For the purpose of prevention of sarcopenia, we will clarify the influence of ingesting Alaska pollack soup once a day on the increase of skeletal muscle mass and muscle strength of the elderly and improvement of health-related quality of life in a randomized controlled trial.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Skeletal muscle mass index (adjusted by body height).
The change of outcome value the between two groups from baseline to 4, 12, and 24 weeks, was compared.

Key secondary outcomes

Total skeletal muscle mass, grip strength, gait speed, knee extension strength, chair stand test, and health-related QOL.
The change of outcome value the between two groups from baseline to 4, 12, and 24 weeks, was compared.


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

YES

Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

For 24 weeks, once a day, ingest the Alaska pollack-derived powder with 120 ml of hot water at breakfast.

Interventions/Control_2

For 24 weeks, once a day, ingest the whey milk-derived powder with 120 ml of hot water at breakfast.

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

65 years-old <=

Age-upper limit

90 years-old >

Gender

Female

Key inclusion criteria

Non-Sarcopenia(sarcopenia diagnostic criteria is Asian Working Group for Sarcopenia. SMI, grip strength,gait speed < cutoff value)
Healthy older women

Key exclusion criteria

<65 years old, diabetes, CKD, chronic cardiac diseases, hepatic disease, respiratory diseases, resistance trainded elderly, joint and motor dysfunction, difficult to eat meals, food allergy (fish, milk, soybeans, chicken),sarcopenia, men.

Target sample size

100


Research contact person

Name of lead principal investigator

1st name Mori
Middle name
Last name Hiroyasu

Organization

University of Tokushima

Division name

Diabetes Therapeutics and Research Center

Zip code

7708503

Address

3-18-15 Kuramoto, Tokushima, Tokushima 770-8503, Japan

TEL

0886337587

Email

mori.hiroyasu@tokushima-u.ac.jp


Public contact

Name of contact person

1st name Mori
Middle name
Last name Hiroyasu

Organization

University of Tokushima

Division name

Diabetes Therapeutics and Research Center

Zip code

7708503

Address

3-18-15 Kuramoto, Tokushima, Tokushima 770-8503, Japan

TEL

0886337587

Homepage URL


Email

mori.hiroyasu@tokushima-u.ac.jp


Sponsor or person

Institute

University of Tokushima, Diabetes Therapeutics and Research Center

Institute

Department

Personal name



Funding Source

Organization

Nippom Suisan Kaisha,Led. Functional,ingredient research section food function R&D center.

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

University of Tokushima

Address

3-18-15 Kuramoto, Tokushima, Tokushima 770-8503, Japan

Tel

0886337587

Email

mori.hiroyasu@tokushima-u.ac.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

2019 Year 04 Month 01 Day


Related information

URL releasing protocol

https://academic.oup.com/jn/advance-article/doi/10.1093/jn/nxac219/6711695?login=true

Publication of results

Unpublished


Result

URL related to results and publications

https://academic.oup.com/jn/advance-article/doi/10.1093/jn/nxac219/6711695?login=true

Number of participants that the trial has enrolled

92

Results

The change in SMI was greater in the APP group compared with the CON group at 24 wk, and knee extension strength was higher at these times, respectively.

Results date posted

2022 Year 10 Month 25 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

healthy women >65 y.

Participant flow

In this double-blind randomized controlled trial, healthy women > 65 y were allocated to an APP or whey protein control (CON) group.

Adverse events

None

Outcome measures

Between-group differences in the change of skeletal muscle mass index (SMI) as the primary outcome.

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Main results already published

Date of protocol fixation

2019 Year 03 Month 31 Day

Date of IRB

2019 Year 03 Month 25 Day

Anticipated trial start date

2019 Year 04 Month 01 Day

Last follow-up date

2019 Year 12 Month 21 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2019 Year 01 Month 30 Day

Last modified on

2022 Year 10 Month 25 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040691


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name