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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000031375
Receipt No. 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 2018/02/19

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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
Institute Medical Corporation Hokubukai Noguchi Hospital
Institute
Department

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 No longer recruiting
Date of protocol fixation
2018 Year 01 Month 05 Day
Date of IRB
Anticipated trial start date
2018 Year 01 Month 16 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 02 Month 19 Day
Last modified on
2018 Year 02 Month 19 Day


Link to view the page
URL(English) https://upload.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


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