UMIN-CTR Clinical Trial

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	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035826