UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000031375
Receipt number R000035826
Scientific Title The effects of functional food ingredient on nutritional status and physical function in healthy senior citizens.
Date of disclosure of the study information 2018/12/31
Last modified on 2020/03/02 14:47:33

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Basic information

Public title

The effects of functional food ingredient on nutritional status and physical function in healthy senior citizens.

Acronym

The effects of functional food ingredient on nutritional status and physical function in healthy senior citizens.

Scientific Title

The effects of functional food ingredient on nutritional status and physical function in healthy senior citizens.

Scientific Title:Acronym

The effects of functional food ingredient on nutritional status and physical function in healthy senior citizens.

Region

Japan


Condition

Condition

Healthy adults

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the effect of functional food ingredient on nutritional status and physical function in healthy senior citizens.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Food intake
Energy intake
Nutrition intake
Physical function
Nutritional status questionnaires

Key secondary outcomes

Albumin
Pre-albumin
Total protein
Body composition
Appetite questionnaires
Activities of daily living questionnaires


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

Prevention

Type of intervention

Food

Interventions/Control_1

Amino acids intake for 8 weeks

Interventions/Control_2

Placebo intake 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



Eligibility

Age-lower limit

65 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1.Person whose food intake weight is less than 1100g in men and 900g in women
2.Person whose age is more than 65 years
3.Person whom responsible doctor allow to join the study referring screening test.
4.Person who provides informed consent by a document.

Key exclusion criteria

1. Person who has the disease which affects appetite and food intake.
2. Person who had a surgical history for excision of the gastrointestinal tract, excluding surgery to excise the appendix.
3. Person who takes the drug which affects appetite and food intake. Example: anticancer agent (fluorouracil, cisplatin etc.), Mazindol, Rikkunshito etc. Responsible doctor judge the participation of person who is taking the other medicine.
4. Person who takes antihistamine.
5. Person who can not walks without anyone's help. (Person who uses a wheelchair.)
6. Person who can not eat regularly (Person who can not eat meal more than 3 times in a week, and can not eat in the daytime.) Shift worker.
7. Person who was diagnosed with dementia.
8. Person who has participated in other clinical study and monitor test (food, medicine, cosmetic and liniment) or are planned to participate in other clinical study.
9. Person who is judged to be inappropriate for current study based on the medical chart by medical doctor.

Target sample size

70


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yasufumi Furuhata

Organization

Ajinomoto Co., Inc

Division name

Institute of Food Sciences and Technologies

Zip code


Address

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

TEL

044-223-4114

Email

yasufumi_furuhata@ajinomoto.com


Public contact

Name of contact person

1st name
Middle name
Last name Tomonori Koizumi

Organization

Ajinomoto Co., Inc.

Division name

Human Health & Nutrition Group Institute of Food Sciences and Technologies

Zip code


Address

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

TEL

044-223-4114

Homepage URL


Email

tomonori_koizumi@ajinomoto.com


Sponsor or person

Institute

Medical Corporation Hokubukai Noguchi Hospital

Institute

Department

Personal name



Funding Source

Organization

Ajinomoto Co., Inc.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor

Clinical Support Corporation

Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



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 北武会 野口病院(北海道)
Medical Corporation Hokubukai Noguchi Hospital


Other administrative information

Date of disclosure of the study information

2018 Year 12 Month 31 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

2018 Year 01 Month 05 Day

Date of IRB

2018 Year 01 Month 05 Day

Anticipated trial start date

2018 Year 01 Month 16 Day

Last follow-up date

2018 Year 04 Month 26 Day

Date of closure to data entry

2018 Year 06 Month 05 Day

Date trial data considered complete

2018 Year 08 Month 08 Day

Date analysis concluded

2019 Year 01 Month 27 Day


Other

Other related information



Management information

Registered date

2018 Year 02 Month 19 Day

Last modified on

2020 Year 03 Month 02 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035826


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name